Study of Magrolimab (Hu5F9-G4) in Combination With Cetuximab in Participants With Solid Tumors and Advanced Colorectal Cancer

Sponsor

Gilead Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT02953782

Collaborator

California Institute for Regenerative Medicine (CIRM) (Other)

Enrollment

Locations

Arms

39.3

Actual Duration (Months)

9.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objectives of this study are: (Phase 1b) to investigate the safety and tolerability and to determine the recommended Phase 2 dose (RP2D) for magrolimab in combination with cetuximab; and (Phase 2) to evaluate overall response rate (ORR) of magrolimab in combination with cetuximab in participants with Kirsten rat sarcoma 2 viral oncogene homolog (KRAS) mutant and KRAS wild-type colorectal cancer (CRC).

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor Colorectal Cancer	Drug: Magrolimab Drug: Cetuximab	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

78 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1b/2 Trial of Hu5F9-G4 in Combination With Cetuximab in Patients With Solid Tumors and Advanced Colorectal Cancer

Actual Study Start Date :

Nov 2, 2016

Actual Primary Completion Date :

Feb 10, 2020

Actual Study Completion Date :

Feb 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2 Participants with solid tumor will receive a priming dose of magrolimab 1 mg/kg of body weight by intravenous (IV) infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, will start on Day 1. Each cycle will consist of 4 weeks (28 days). Cetuximab will be administered 1 hour prior to magrolimab infusion on days when both are given. Treatment will be administered until unacceptable toxicity, voluntary withdrawal, or documented progressive disease (PD).	Drug: Magrolimab Administered intravenously Other Names: Hu5F9-G4 Drug: Cetuximab Administered intravenously Other Names: ERBITUX®
Experimental: Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2 Participants with solid tumor will receive a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, will start on Day 1. Each cycle will consist of 4 weeks (28 days). Cetuximab will be administered 1 hour prior to magrolimab infusion on days when both are given. Treatment will be administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Drug: Magrolimab Administered intravenously Other Names: Hu5F9-G4 Drug: Cetuximab Administered intravenously Other Names: ERBITUX®
Experimental: Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2 Participants with solid tumor will receive a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, will start on Day 1. Each cycle will consist of 4 weeks (28 days). Cetuximab will be administered 1 hour prior to magrolimab infusion on days when both are given. Treatment will be administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Drug: Magrolimab Administered intravenously Other Names: Hu5F9-G4 Drug: Cetuximab Administered intravenously Other Names: ERBITUX®
Experimental: Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2 Participants with solid tumor will receive a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, will start on Day 1. Each cycle will consist of 4 weeks (28 days). Cetuximab will be administered 1 hour prior to magrolimab infusion on days when both were given. Treatment will be administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Drug: Magrolimab Administered intravenously Other Names: Hu5F9-G4 Drug: Cetuximab Administered intravenously Other Names: ERBITUX®
Experimental: Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2 Participants with solid tumor will receive a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants will also receive a loading dose of magrolimab 45 mg/kg on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab will start on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle will consist of 4 weeks. Treatment will be administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Drug: Magrolimab Administered intravenously Other Names: Hu5F9-G4 Drug: Cetuximab Administered intravenously Other Names: ERBITUX®
Experimental: Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2 Participants with advanced colorectal cancer (CRC) who are KRAS wild type (KRASwt) and are refractory to anti-EGFRmAb therapy will receive a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab will start on Day 1; Days 8 and 22 are removed from Cycle 2 onwards for magrolimab. Each cycle will consist of 4 weeks. Cetuximab will be administered 1 hour prior to magrolimab infusion on days when both are given. Treatment will be administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Drug: Magrolimab Administered intravenously Other Names: Hu5F9-G4 Drug: Cetuximab Administered intravenously Other Names: ERBITUX®
Experimental: Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2 Participants with advanced CRC with KRAS mutation (KRASm) who have progressed or are not candidates for oxaliplatin or irinotecan-based therapy will receive a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab will start on Day 1; Days 8 and 22 are removed from Cycle 2 onwards for magrolimab. Each cycle will consist of 4 weeks. Treatment will be administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Drug: Magrolimab Administered intravenously Other Names: Hu5F9-G4 Drug: Cetuximab Administered intravenously Other Names: ERBITUX®
Experimental: Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2 Participants with advanced CRC with KRASm who have progressed or are not candidates for oxaliplatin or irinotecan-based therapy will receive a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approx. 3 hours) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approx. 2 hours) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants will also receive a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab will start on Day 1; Days 8 and 22 are removed from Cycle 3 onwards for magrolimab. Each cycle will consist of 4 weeks. Treatment will be administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Drug: Magrolimab Administered intravenously Other Names: Hu5F9-G4 Drug: Cetuximab Administered intravenously Other Names: ERBITUX®

Outcome Measures

Primary Outcome Measures

Percentage of Participants With Dose Limiting Toxicities (DLT) [From first dose up to Day 28]
DLT was defined as any Grade (GR) 3 or greater adverse event (AE) that was assessed as related to study treatment with the exceptions of: GR 3: anemia (hemolytic anemia that is medically significant tis considered a DLT), indirect/unconjugated hyperbilirubinemia, electrolyte abnormalities, elevation in alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase that resolved to ≤ Grade 2 with supportive care within 1 week and is not associated with other clinically significant consequences; nausea, vomiting, or diarrhea that resolved to ≤ Grade 2 with supportive care within 72 hours; fatigue that resolved to ≤ Grade 2 within 2 weeks on study; drug-related infusion reactions in the absence of an optimal pretreatment regimen; tumor lysis syndrome or electrolyte disturbances, hypomagnesemia, that resolved to ≤ Grade 2 or baseline within 1 week; GR 3 or 4: lymphopenia or leukopenia.
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) [From first dose date up to last dose date plus 30 days (maximum: 15.3 months)]
An AE was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE was any unfavorable and unintended sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the investigational medicinal product. A TEAE was defined as AEs worsening or occurring during or after a participant's first exposure to study drug and within 30 days after the last administration of study drug or initiation of new anticancer therapy, whichever occurred first.
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [From Screening until 38.89 months (assessed on Day 1 of Cycle 3 then every 8 weeks [Q8W] from Cycle 5 onwards up to 38.89 months; 1 cycle = 4 weeks)]
Objective response rate was defined as the percentage of participants with objective response which consisted of complete response (CR)+ partial response (PR) determined by RECIST v 1.1. CR: Disappearance of all target and all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (< 10 mm short axis). Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Secondary Outcome Measures

Pharmacokinetic (PK) Parameter: Cmax of Magrolimab [Pre-magrolimab dose (within 12 hours) and 1-hour post-magrolimab dose (infusion duration = approximately 3 hours on Day 1 and 2 hours on other days) on Days 1 (Cycle 1 Day 1), 8 (Cycle 1 Day 8), and 29 (Cycle 2 Day 1) (1 cycle = 4 weeks)]
Cmax is defined as the maximum concentration of drug.
PK Parameter: Tmax of Magrolimab [Pre-magrolimab dose (within 12 hours) and 1-hour post-magrolimab dose (infusion duration = approximately 3 hours on Day 1 and 2 hours on other days) on Days 8 (Cycle 1 Day 8) and 29 (Cycle 2 Day 1) (1 cycle = 4 weeks)]
Tmax is defined as the time (observed time point) of Cmax.
PK Parameter: AUClast of Magrolimab [Pre-magrolimab dose (within 12 hours) and 1-hour post-magrolimab dose (infusion duration = approximately 3 hours on Day 1 and 2 hours on other days) on Days 8 (Cycle 1 Day 8) and 29 (Cycle 2 Day 1) (1 cycle = 4 weeks)]
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
PK Parameter: AUCtau of Magrolimab [Pre-magrolimab dose (within 12 hours) and 1-hour post-magrolimab dose (infusion duration = approximately 3 hours on Day 1 and 2 hours on other days) on Days 8 (Cycle 1 Day 8) and 29 (Cycle 2 Day 1) (1 cycle = 4 weeks)]
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Percentage of Participants With Anti-drug Antibodies (ADA) [Baseline; post-treatment (assessed continuously up to 30 days after last dose; maximum 15.3 months )]
Percentage of Participants With Positive ADA at any timepoint was reported.
Disease Control Rate (DCR) as Assessed by RECIST v1.1 [From Screening until 38.89 months (assessed on Cycle 3 Day 1 then every 8 weeks from Cycle 5 onwards up to 38.89 months; 1 cycle = 4 weeks)]
DCR was defined as the percentage of participants with disease control which consisted of CR+PR+SD. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters measured while on study. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions.
Duration of Response (DOR) as Assessed by RECIST v1.1 [From first objective response until documented PD (assessed on Cycle 3 Day 1 then every 8 weeks from Cycle 5 onwards up to 38.89 months; 1 cycle = 4 weeks)]
DOR was measured from when the first (objective) response was met (i.e., CR or PR) until the first date of objectively documented PD. Participants who did not have objectively PD was censored at their last documented progression-free date. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. Kaplan Meier estimate was used for analysis.
Progression Free Survival (PFS) as Assessed by RECIST v1.1 [From first dose until documented PD/death (assessed on Cycle 3 Day 1 then every 8 weeks from Cycle 5 onwards up to 38.89 months; 1 cycle = 4 weeks)]
PFS was measured from first dose until the first date of objectively documented PD or death. Participants who did not have objectively documented PD and not died was censored at their last documented progression-free date. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. Kaplan Meier estimate was used for analysis.
Overall Survival (OS) [From first dose until death (assessed on Cycle 3 Day 1 then every 8 weeks from Cycle 5 onwards up to 38.89 months; 1 cycle = 4 weeks)]
OS was measured from first dose until death. Participants who did not die were censored at their last known alive date. Kaplan Meier estimate was used for analysis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

Histological Diagnosis
Phase 1b only: Advanced solid malignancy with an emphasis on colorectal cancer (CRC), head and neck, breast, pancreatic and ovarian cancers who have been treated with at least one regimen of prior systemic therapy, or who refuse systemic therapy, and for which there is no curative therapy available.
Phase 2:
KRAS Mutant CRC: Advanced KRAS mutant CRC who have progressed or are ineligible for both irinotecan and oxaliplatin based chemotherapy
KRAS Wild-Type CRC: Advanced KRAS wild type CRC who have progressed or are ineligible for fluoropyrimidine, irinotecan, and oxaliplatin based chemotherapy and who are relapsed or refractory to at least 1 prior systemic therapy that included an anti-epidermal growth factor receptor (EGFR) antibody, such as cetuximab, panitumumab or others.
Adequate performance status and hematological, liver, and kidney function
Phase 2 only: Willing to consent to 1 mandatory pre-treatment and 1 on-treatment tumor biopsy

Key Exclusion Criteria:

Active brain metastases
Prior treatment with cluster of differentiation 47 (CD47) or signal regulatory protein alpha (SIRPα) targeting agents.
Phase 2 only: second malignancy within the last 3 years.
Known active or chronic hepatitis B or C infection or human immunodeficiency virus (HIV)
Pregnancy or active breastfeeding

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA	Los Angeles	California	United States	90404
2	Stanford University	Palo Alto	California	United States	94305-5757
3	Wayne State University	Detroit	Michigan	United States	48201
4	START Midwest	Grand Rapids	Michigan	United States	49503
5	UPENN	Philadelphia	Pennsylvania	United States	19104
6	Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203
7	Md Anderson	Houston	Texas	United States	77030
8	START Center for Cancer Care	San Antonio	Texas	United States	78229

Sponsors and Collaborators

Gilead Sciences
California Institute for Regenerative Medicine (CIRM)

Investigators

Study Director: Gilead Study Director, Gilead Sciences

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Gilead Sciences

ClinicalTrials.gov Identifier:

NCT02953782

Other Study ID Numbers:

5F9004

First Posted:

Nov 3, 2016

Last Update Posted:

Mar 1, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colorectal Neoplasms

Cetuximab

Magrolimab

Study Results

Participant Flow

Recruitment Details	Participants were enrolled at study sites in United States. The first participant was screened on 02 November 2016. The last study visit occurred on 10 February 2020.
Pre-assignment Detail	105 participants were screened.

Arm/Group Title	Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2	Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2	Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2	Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2	Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2	Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2	Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2	Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Arm/Group Description	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by intravenous (IV) infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented progressive disease (PD).	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with advanced colorectal cancer (CRC) who were KRAS wild type (KRASwt) and were refractory to anti-EGFRmAb therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with advanced CRC with KRAS mutation (KRASm) who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Period Title: Phase 1b (Maximum Duration: 14.3 Months)
STARTED	6	3	9	8	6	0	0	0
COMPLETED	0	0	0	0	0	0	0	0
NOT COMPLETED	6	3	9	8	6	0	0	0
Period Title: Phase 1b (Maximum Duration: 14.3 Months)
STARTED	0	0	0	0	0	16	15	15
COMPLETED	0	0	0	0	0	0	0	0
NOT COMPLETED	0	0	0	0	0	16	15	15

Baseline Characteristics

Arm/Group Title	Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2	Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2	Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2	Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2	Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2	Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2	Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2	Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2	Total
Arm/Group Description	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Total of all reporting groups
Overall Participants	6	3	9	8	6	16	15	15	78
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.6 (6.72)	68.6 (11.39)	57.3 (7.05)	52.4 (10.97)	63.6 (9.50)	59.7 (14.38)	58.9 (14.41)	57.4 (5.80)	58.9 (11.13)
Sex: Female, Male (Count of Participants)
Female	2 33.3%	0 0%	2 22.2%	2 25%	2 33.3%	6 37.5%	8 53.3%	5 33.3%	27 34.6%
Male	4 66.7%	3 100%	7 77.8%	6 75%	4 66.7%	10 62.5%	7 46.7%	10 66.7%	51 65.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 16.7%	0 0%	1 11.1%	0 0%	1 16.7%	4 25%	1 6.7%	0 0%	8 10.3%
Not Hispanic or Latino	5 83.3%	3 100%	8 88.9%	8 100%	5 83.3%	12 75%	13 86.7%	11 73.3%	65 83.3%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 6.7%	4 26.7%	5 6.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	1 6.3%	0 0%	0 0%	1 1.3%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%	1 6.3%	1 6.7%	3 20%	5 6.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	1 16.7%	0 0%	1 11.1%	0 0%	0 0%	2 12.5%	1 6.7%	0 0%	5 6.4%
White	5 83.3%	3 100%	7 77.8%	8 100%	6 100%	8 50%	10 66.7%	8 53.3%	55 70.5%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	1 11.1%	0 0%	0 0%	4 25%	3 20%	4 26.7%	12 15.4%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Dose Limiting Toxicities (DLT)
Description	DLT was defined as any Grade (GR) 3 or greater adverse event (AE) that was assessed as related to study treatment with the exceptions of: GR 3: anemia (hemolytic anemia that is medically significant tis considered a DLT), indirect/unconjugated hyperbilirubinemia, electrolyte abnormalities, elevation in alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase that resolved to ≤ Grade 2 with supportive care within 1 week and is not associated with other clinically significant consequences; nausea, vomiting, or diarrhea that resolved to ≤ Grade 2 with supportive care within 72 hours; fatigue that resolved to ≤ Grade 2 within 2 weeks on study; drug-related infusion reactions in the absence of an optimal pretreatment regimen; tumor lysis syndrome or electrolyte disturbances, hypomagnesemia, that resolved to ≤ Grade 2 or baseline within 1 week; GR 3 or 4: lymphopenia or leukopenia.
Time Frame	From first dose up to Day 28

Outcome Measure Data

Analysis Population Description
DLT Evaluable Analysis Set included participants who received at least 1 dose of any study drugs during Phase 1b if the participant either experienced a DLT any time during the DLT assessment period (the first 4 weeks of treatment) or completed at least 4 infusions of magrolimab and 2 infusions of cetuximab.

Arm/Group Title	Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2	Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2	Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2	Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2	Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2	Phase 2 Cohort 1 Safety Run-in: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2
Arm/Group Description	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1.After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) in combination with cetuximab 250 mg/m^2 infusions given over 60 minutes.
Measure Participants	6	3	9	7	6	9
Number [percentage of participants]	16.7 278.3%	0.0 0%	0.0 0%	14.3 178.8%	0.0 0%	0.0 0%

2. Primary Outcome

Title	Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Description	An AE was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE was any unfavorable and unintended sign, symptom, disease, and/or laboratory or physiological observation that may or may not be related to the investigational medicinal product. A TEAE was defined as AEs worsening or occurring during or after a participant's first exposure to study drug and within 30 days after the last administration of study drug or initiation of new anticancer therapy, whichever occurred first.
Time Frame	From first dose date up to last dose date plus 30 days (maximum: 15.3 months)

Outcome Measure Data

Analysis Population Description
All Treated included all participants who received at least 1 dose of any study drugs.

Arm/Group Title	Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2	Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2	Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2	Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2	Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2	Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2	Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2	Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2	Magrolimab Priming Dose Only
Arm/Group Description	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants who received only the priming dose (1 mg/kg) of magrolimab in Phase 2 of the study.
Measure Participants	6	3	10	7	6	14	15	14	3
Number [percentage of participants]	100.0 1666.7%	100.0 3333.3%	100.0 1111.1%	100.0 1250%	100.0 1666.7%	100.0 625%	100.0 666.7%	100.0 666.7%	100.0 128.2%

3. Primary Outcome

Title	Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Description	Objective response rate was defined as the percentage of participants with objective response which consisted of complete response (CR)+ partial response (PR) determined by RECIST v 1.1. CR: Disappearance of all target and all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (< 10 mm short axis). Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time Frame	From Screening until 38.89 months (assessed on Day 1 of Cycle 3 then every 8 weeks [Q8W] from Cycle 5 onwards up to 38.89 months; 1 cycle = 4 weeks)

Outcome Measure Data

Analysis Population Description
Participants in All Treated with available data were analyzed. Efficacy results were planned to be reported separately for all CRC participants with KRASwt and KRASm tumors.

Arm/Group Title	KRASwt CRC	KRASm CRC
Arm/Group Description	All CRC participants with KRASwt tumors who received assigned magrolimab doses in combination with cetuximab in any part of the study.	All CRC participants with KRASm tumors who received assigned magrolimab doses in combination with cetuximab in any part of the study.
Measure Participants	32	42
Number (95% Confidence Interval) [percentage of participants]	6.3 105%	0.0 0%

4. Secondary Outcome

Title	Pharmacokinetic (PK) Parameter: Cmax of Magrolimab
Description	Cmax is defined as the maximum concentration of drug.
Time Frame	Pre-magrolimab dose (within 12 hours) and 1-hour post-magrolimab dose (infusion duration = approximately 3 hours on Day 1 and 2 hours on other days) on Days 1 (Cycle 1 Day 1), 8 (Cycle 1 Day 8), and 29 (Cycle 2 Day 1) (1 cycle = 4 weeks)

Outcome Measure Data

Analysis Population Description
Participants in the PK Analysis Set (participants who received any amount of magrolimab with at least one detectable post-treatment serum concentration of magrolimab) with available data were analyzed.

Arm/Group Title	Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2	Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2	Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2	Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2	Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2	Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2	Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2	Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Arm/Group Description	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with advanced CRC with KRAS mutation who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Measure Participants	6	3	10	7	6	15	14	11
Day 1 (Cycle 1 Day 1)	1.04 (0.769)	0.629 (0.437)	0.662 (0.374)	0.432 (0.173)	0.517 (0.311)	0.479 (0.170)	0.559 (0.254)	0.525 (0.296)
Day 8 (Cycle 1 Day 8)	209 (82.0)	230 (54.6)	455 (105)	558 (168)	1100 (287)	513 (148)	616 (121)	901 (131)
Day 29 (Cycle 2 Day 1)	312 (121)	352 (68.4)	728 (207)	982 (182)	2140 (590)	775 (110)	1790 (49.5)

5. Secondary Outcome

Title	PK Parameter: Tmax of Magrolimab
Description	Tmax is defined as the time (observed time point) of Cmax.
Time Frame	Pre-magrolimab dose (within 12 hours) and 1-hour post-magrolimab dose (infusion duration = approximately 3 hours on Day 1 and 2 hours on other days) on Days 8 (Cycle 1 Day 8) and 29 (Cycle 2 Day 1) (1 cycle = 4 weeks)

Outcome Measure Data

Analysis Population Description
Participants in the PK Analysis Set with available data were analyzed.

Arm/Group Title	Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2	Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2	Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2	Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2	Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2	Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2	Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2	Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Arm/Group Description	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Measure Participants	6	3	9	7	6	9	14	11
Day 8 (Cycle 1 Day 8)	0.10	0.12	0.12	0.14	0.13	0.12	0.13	0.12
Day 29 (Cycle 2 Day 1)	0.94	0.13	0.13	0.13	0.12	0.14	0.12

6. Secondary Outcome

Title	PK Parameter: AUClast of Magrolimab
Description	AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Time Frame	Pre-magrolimab dose (within 12 hours) and 1-hour post-magrolimab dose (infusion duration = approximately 3 hours on Day 1 and 2 hours on other days) on Days 8 (Cycle 1 Day 8) and 29 (Cycle 2 Day 1) (1 cycle = 4 weeks)

Outcome Measure Data

Analysis Population Description
Participants in the PK Analysis Set with available data were analyzed.

Arm/Group Title	Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2	Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2	Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2	Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2	Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2	Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2	Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2	Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Arm/Group Description	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Measure Participants	5	3	9	6	6	1	0	0
Day 8 (Cycle 1 Day 8)	676 (75.3)	1530 (513)	2140 (726)	2920 (600)	1930
Day 29 (Cycle 2 Day 1)	1420 (711)	1560 (413)	3330 (1270)	4480 (1220)	7340 (2380)

7. Secondary Outcome

Title	PK Parameter: AUCtau of Magrolimab
Description	AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Time Frame	Pre-magrolimab dose (within 12 hours) and 1-hour post-magrolimab dose (infusion duration = approximately 3 hours on Day 1 and 2 hours on other days) on Days 8 (Cycle 1 Day 8) and 29 (Cycle 2 Day 1) (1 cycle = 4 weeks)

Outcome Measure Data

Analysis Population Description
Participants in the PK Analysis Set with available data were analyzed.

Arm/Group Title	Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2	Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2	Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2	Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2	Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2	Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2	Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2	Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Arm/Group Description	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Measure Participants	4	3	7	6	4	1	0	0
Day 8 (Cycle 1 Day 8)	676 (75.3)	1630 (649)	2140 (726)	1930
Day 29 (Cycle 2 Day 1)	1640 (604)	1560 (413)	3630 (1040)	4480 (1220)	8770 (1120)

8. Secondary Outcome

Title	Percentage of Participants With Anti-drug Antibodies (ADA)
Description	Percentage of Participants With Positive ADA at any timepoint was reported.
Time Frame	Baseline; post-treatment (assessed continuously up to 30 days after last dose; maximum 15.3 months )

Outcome Measure Data

Analysis Population Description
Immunogenicity Analysis Set included participants with at least one reported ADA result.

Arm/Group Title	Phase 1b Cohort 1: Magrolimab 10 mg/kg + Cetuximab 200 mg/m^2	Phase 1b Cohort 2: Magrolimab 10 mg/kg + Cetuximab 250 mg/m^2	Phase 1b Cohort 3: Magrolimab 20 mg/kg + Cetuximab 250 mg/m^2	Phase 1b Cohort 4: Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2	Phase 1b Cohort 5: Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2	Phase 2 Cohort 1 (KRASwt): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2	Phase 2 Cohort 2 (KRASm): Magrolimab 30 mg/kg + Cetuximab 250 mg/m^2	Phase 2 Cohort 3 (KRASm): Magrolimab 45 mg/kg + Cetuximab 250 mg/m^2
Arm/Group Description	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 300 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 200 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 10 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 20 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1 and thereafter, weekly maintenance dose for both magrolimab and cetuximab, started on Day 1. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with solid tumor received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1 with weekly dose in Cycle 2 and bi-weekly dose in Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with advanced CRC who were KRASwt and were refractory to anti-EGFRmAb therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 30 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 2 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.	Participants with advanced CRC with KRASm who had progressed or were not candidates for oxaliplatin or irinotecan-based therapy received a priming dose of magrolimab 1 mg/kg of body weight by IV infusion (approximately 3 hours infusion) on Day 1 followed by a maintenance dose of magrolimab 45 mg/kg of body weight by IV infusion (approximately 2 hours infusion) weekly starting on Day 8 followed by Days 15 and 22 in combination with cetuximab at a loading dose of 400 mg/m^2 infused over 120-minutes on Day 8 followed by a weekly maintenance dose of 250 mg/m^2 infusions given over 60 minutes on Days 15 and 22, in Cycle 1. Participants also received a loading dose of magrolimab 45 mg/kg of body weight on Day 11 of Cycle 1. After Cycle 1, maintenance dose for both magrolimab and cetuximab started on Day 1; Days 8 and 22 were removed from Cycle 3 onwards for magrolimab. Each cycle consisted of 4 weeks (28 days). Cetuximab was administered 1 hour prior to magrolimab infusion on days when both were given. Treatment was administered until unacceptable toxicity, voluntary withdrawal, or documented PD.
Measure Participants	6	3	10	7	6	16	15	15
Baseline ADA	0.00 0%	0.00 0%	0.00 0%	14.3 178.8%	0.00 0%	6.3 39.4%	0.00 0%	0.00 0%
Post-Treatment ADA	33.3 555%	0.00 0%	0.00 0%	0.00 0%	0.00 0%	6.3 39.4%	13.3 88.7%	0.00 0%
Overall ADA	33.3 555%	0.00 0%	0.00 0%	14.3 178.8%	0.00 0%	12.5 78.1%	13.3 88.7%	0.00 0%

9. Secondary Outcome

Title	Disease Control Rate (DCR) as Assessed by RECIST v1.1
Description	DCR was defined as the percentage of participants with disease control which consisted of CR+PR+SD. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters measured while on study. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions.
Time Frame	From Screening until 38.89 months (assessed on Cycle 3 Day 1 then every 8 weeks from Cycle 5 onwards up to 38.89 months; 1 cycle = 4 weeks)

Outcome Measure Data

Analysis Population Description
Participants in All Treated with available data were analyzed. Efficacy results were planned to be reported separately for all CRC participants with KRASwt and KRASm tumors.

Arm/Group Title	KRASwt CRC	KRASm CRC
Arm/Group Description	All CRC participants with KRASwt tumors who received assigned magrolimab doses in combination with cetuximab in any part of the study.	All CRC participants with KRASm tumors who received assigned magrolimab doses in combination with cetuximab in any part of the study.
Measure Participants	32	42
Number (95% Confidence Interval) [percentage of participants]	50.0 833.3%	38.1 1270%

10. Secondary Outcome

Title	Duration of Response (DOR) as Assessed by RECIST v1.1
Description	DOR was measured from when the first (objective) response was met (i.e., CR or PR) until the first date of objectively documented PD. Participants who did not have objectively PD was censored at their last documented progression-free date. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. Kaplan Meier estimate was used for analysis.
Time Frame	From first objective response until documented PD (assessed on Cycle 3 Day 1 then every 8 weeks from Cycle 5 onwards up to 38.89 months; 1 cycle = 4 weeks)

Outcome Measure Data

Analysis Population Description
Participants in All Treated with available data were analyzed. Efficacy results were planned to be reported separately for all CRC participants with KRASwt and KRASm tumors.

Arm/Group Title	KRASwt CRC	KRASm CRC
Arm/Group Description	All CRC participants with KRASwt tumors who received assigned magrolimab doses in combination with cetuximab in any part of the study.	All CRC participants with KRASm tumors who received assigned magrolimab doses in combination with cetuximab in any part of the study.
Measure Participants	2	0
Median (95% Confidence Interval) [months]	9.7

11. Secondary Outcome

Title	Progression Free Survival (PFS) as Assessed by RECIST v1.1
Description	PFS was measured from first dose until the first date of objectively documented PD or death. Participants who did not have objectively documented PD and not died was censored at their last documented progression-free date. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. Kaplan Meier estimate was used for analysis.
Time Frame	From first dose until documented PD/death (assessed on Cycle 3 Day 1 then every 8 weeks from Cycle 5 onwards up to 38.89 months; 1 cycle = 4 weeks)

Outcome Measure Data

Analysis Population Description
Participants in All Treated with available data were analyzed. Efficacy results were planned to be reported separately for all CRC participants with KRASwt and KRASm tumors.

Arm/Group Title	KRASwt CRC	KRASm CRC
Arm/Group Description	All CRC participants with KRASwt tumors who received assigned magrolimab doses in combination with cetuximab in any part of the study.	All CRC participants with KRASm tumors who received assigned magrolimab doses in combination with cetuximab in any part of the study.
Measure Participants	32	42
Median (95% Confidence Interval) [months]	3.6	1.9

12. Secondary Outcome

Title	Overall Survival (OS)
Description	OS was measured from first dose until death. Participants who did not die were censored at their last known alive date. Kaplan Meier estimate was used for analysis.
Time Frame	From first dose until death (assessed on Cycle 3 Day 1 then every 8 weeks from Cycle 5 onwards up to 38.89 months; 1 cycle = 4 weeks)

Outcome Measure Data

Analysis Population Description
Participants in All Treated with available data were analyzed. Efficacy results were planned to be reported separately for all CRC participants with KRASwt and KRASm tumors.

Arm/Group Title	KRASwt CRC	KRASm CRC
Arm/Group Description	All CRC participants with KRASwt tumors who received assigned magrolimab doses in combination with cetuximab in any part of the study.	All CRC participants with KRASm tumors who received assigned magrolimab doses in combination with cetuximab in any part of the study.
Measure Participants	32	42
Median (95% Confidence Interval) [months]	9.5	7.6

Adverse Events

	Magrolimab 10 mg/kg		Magrolimab 20 mg/kg		Magrolimab 30 mg/kg		Magrolimab 45 mg/kg		Magrolimab Priming Dose Only
Time Frame	Adverse Events: From first dose date up to last dose date plus 30 days (maximum: 15.3 months); All-Cause mortality: From first dose date up to 38.89 months
Adverse Event Reporting Description	All Treated participants included all participants who received at least 1 dose of any study drugs. Per planned analysis, AE data were summarized by the magrolimab maintenance dose level.

Arm/Group Title	Magrolimab 10 mg/kg		Magrolimab 20 mg/kg		Magrolimab 30 mg/kg		Magrolimab 45 mg/kg		Magrolimab Priming Dose Only
Arm/Group Description	Participants who received magrolimab maintenance dose of 10 mg/kg in combination with cetuximab in any part of the study.		Participants who received magrolimab maintenance dose of 20 mg/kg in combination with cetuximab in any part of the study.		Participants who received magrolimab maintenance dose of 30 mg/kg in combination with cetuximab in any part of the study.		Participants who received magrolimab maintenance dose of 45 mg/kg in combination with cetuximab in any part of the study.		Participants who received only the priming dose (1 mg/kg) of magrolimab in Phase 2 of the study.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/9 (77.8%)		8/10 (80%)		30/36 (83.3%)		14/20 (70%)		3/3 (100%)
Serious Adverse Events
	Magrolimab 10 mg/kg		Magrolimab 20 mg/kg		Magrolimab 30 mg/kg		Magrolimab 45 mg/kg		Magrolimab Priming Dose Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/9 (33.3%)		6/10 (60%)		10/36 (27.8%)		5/20 (25%)		1/3 (33.3%)
Blood and lymphatic system disorders
Anaemia	0/9 (0%)		1/10 (10%)		1/36 (2.8%)		0/20 (0%)		0/3 (0%)
Immune thrombocytopenic purpura	0/9 (0%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Cardiac disorders
Bradycardia	0/9 (0%)		1/10 (10%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Gastrointestinal disorders
Constipation	0/9 (0%)		1/10 (10%)		0/36 (0%)		0/20 (0%)		1/3 (33.3%)
Enterocolitis	0/9 (0%)		0/10 (0%)		1/36 (2.8%)		0/20 (0%)		0/3 (0%)
Faecaloma	0/9 (0%)		1/10 (10%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Large intestinal obstruction	0/9 (0%)		1/10 (10%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Small intestinal obstruction	2/9 (22.2%)		0/10 (0%)		1/36 (2.8%)		1/20 (5%)		0/3 (0%)
General disorders
Complication associated with device	0/9 (0%)		1/10 (10%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Pyrexia	0/9 (0%)		1/10 (10%)		1/36 (2.8%)		0/20 (0%)		0/3 (0%)
Infections and infestations
Bacterial sepsis	0/9 (0%)		1/10 (10%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Cystitis	0/9 (0%)		0/10 (0%)		1/36 (2.8%)		0/20 (0%)		0/3 (0%)
Post procedural infection	0/9 (0%)		0/10 (0%)		1/36 (2.8%)		0/20 (0%)		0/3 (0%)
Urinary tract infection	0/9 (0%)		2/10 (20%)		1/36 (2.8%)		0/20 (0%)		0/3 (0%)
Injury, poisoning and procedural complications
Infusion related reaction	0/9 (0%)		0/10 (0%)		2/36 (5.6%)		0/20 (0%)		0/3 (0%)
Investigations
Bilirubin conjugated increased	0/9 (0%)		0/10 (0%)		1/36 (2.8%)		0/20 (0%)		0/3 (0%)
International normalised ratio increased	0/9 (0%)		1/10 (10%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Metabolism and nutrition disorders
Dehydration	0/9 (0%)		1/10 (10%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Hyperkalaemia	0/9 (0%)		1/10 (10%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Hypokalaemia	0/9 (0%)		0/10 (0%)		1/36 (2.8%)		0/20 (0%)		0/3 (0%)
Musculoskeletal and connective tissue disorders
Pathological fracture	0/9 (0%)		1/10 (10%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression	1/9 (11.1%)		1/10 (10%)		3/36 (8.3%)		1/20 (5%)		1/3 (33.3%)
Tumour pain	0/9 (0%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Nervous system disorders
Cerebrovascular accident	1/9 (11.1%)		0/10 (0%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Renal and urinary disorders
Acute kidney injury	0/9 (0%)		1/10 (10%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	0/9 (0%)		0/10 (0%)		1/36 (2.8%)		0/20 (0%)		0/3 (0%)
Respiratory failure	0/9 (0%)		0/10 (0%)		1/36 (2.8%)		1/20 (5%)		0/3 (0%)
Vascular disorders
Haemorrhage	0/9 (0%)		1/10 (10%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Magrolimab 10 mg/kg		Magrolimab 20 mg/kg		Magrolimab 30 mg/kg		Magrolimab 45 mg/kg		Magrolimab Priming Dose Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/9 (100%)		10/10 (100%)		36/36 (100%)		20/20 (100%)		3/3 (100%)
Blood and lymphatic system disorders
Anaemia	1/9 (11.1%)		1/10 (10%)		11/36 (30.6%)		4/20 (20%)		0/3 (0%)
Immune thrombocytopenic purpura	0/9 (0%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Iron deficiency anaemia	0/9 (0%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Lymph node pain	0/9 (0%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Lymphopenia	1/9 (11.1%)		0/10 (0%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Cardiac disorders
Palpitations	1/9 (11.1%)		0/10 (0%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Tachycardia	0/9 (0%)		1/10 (10%)		1/36 (2.8%)		0/20 (0%)		0/3 (0%)
Ear and labyrinth disorders
Deafness	0/9 (0%)		0/10 (0%)		0/36 (0%)		0/20 (0%)		1/3 (33.3%)
Tinnitus	2/9 (22.2%)		0/10 (0%)		1/36 (2.8%)		0/20 (0%)		0/3 (0%)
Eye disorders
Blepharal pigmentation	0/9 (0%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Conjunctivitis allergic	1/9 (11.1%)		0/10 (0%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Dry eye	1/9 (11.1%)		0/10 (0%)		1/36 (2.8%)		0/20 (0%)		0/3 (0%)
Photopsia	1/9 (11.1%)		2/10 (20%)		2/36 (5.6%)		0/20 (0%)		0/3 (0%)
Strabismus	0/9 (0%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Vision blurred	0/9 (0%)		0/10 (0%)		3/36 (8.3%)		0/20 (0%)		0/3 (0%)
Vitreous floaters	0/9 (0%)		0/10 (0%)		3/36 (8.3%)		0/20 (0%)		0/3 (0%)
Gastrointestinal disorders
Abdominal distension	1/9 (11.1%)		3/10 (30%)		4/36 (11.1%)		1/20 (5%)		0/3 (0%)
Abdominal pain	3/9 (33.3%)		3/10 (30%)		6/36 (16.7%)		2/20 (10%)		2/3 (66.7%)
Abdominal pain lower	0/9 (0%)		1/10 (10%)		1/36 (2.8%)		0/20 (0%)		0/3 (0%)
Abdominal pain upper	0/9 (0%)		1/10 (10%)		3/36 (8.3%)		0/20 (0%)		0/3 (0%)
Ascites	0/9 (0%)		1/10 (10%)		1/36 (2.8%)		0/20 (0%)		0/3 (0%)
Constipation	1/9 (11.1%)		5/10 (50%)		6/36 (16.7%)		6/20 (30%)		0/3 (0%)
Diarrhoea	4/9 (44.4%)		3/10 (30%)		9/36 (25%)		7/20 (35%)		1/3 (33.3%)
Dry mouth	0/9 (0%)		1/10 (10%)		2/36 (5.6%)		0/20 (0%)		0/3 (0%)
Dyspepsia	1/9 (11.1%)		1/10 (10%)		1/36 (2.8%)		0/20 (0%)		0/3 (0%)
Dysphagia	0/9 (0%)		1/10 (10%)		1/36 (2.8%)		0/20 (0%)		0/3 (0%)
Enterocolitis	0/9 (0%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Gastrooesophageal reflux disease	1/9 (11.1%)		0/10 (0%)		1/36 (2.8%)		1/20 (5%)		1/3 (33.3%)
Glossodynia	0/9 (0%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Hypoaesthesia oral	1/9 (11.1%)		0/10 (0%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Intestinal obstruction	0/9 (0%)		1/10 (10%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Loose tooth	0/9 (0%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Nausea	2/9 (22.2%)		2/10 (20%)		16/36 (44.4%)		3/20 (15%)		1/3 (33.3%)
Oesophageal pain	1/9 (11.1%)		0/10 (0%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Rectal discharge	0/9 (0%)		0/10 (0%)		2/36 (5.6%)		0/20 (0%)		0/3 (0%)
Stomatitis	0/9 (0%)		2/10 (20%)		8/36 (22.2%)		6/20 (30%)		0/3 (0%)
Vomiting	1/9 (11.1%)		3/10 (30%)		11/36 (30.6%)		4/20 (20%)		1/3 (33.3%)
General disorders
Chest discomfort	1/9 (11.1%)		0/10 (0%)		1/36 (2.8%)		1/20 (5%)		0/3 (0%)
Chest pain	0/9 (0%)		1/10 (10%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Chills	2/9 (22.2%)		2/10 (20%)		11/36 (30.6%)		5/20 (25%)		0/3 (0%)
Early satiety	0/9 (0%)		1/10 (10%)		1/36 (2.8%)		1/20 (5%)		0/3 (0%)
Fatigue	4/9 (44.4%)		5/10 (50%)		18/36 (50%)		7/20 (35%)		0/3 (0%)
Gait disturbance	0/9 (0%)		0/10 (0%)		0/36 (0%)		0/20 (0%)		1/3 (33.3%)
Influenza like illness	0/9 (0%)		0/10 (0%)		1/36 (2.8%)		1/20 (5%)		0/3 (0%)
Non-cardiac chest pain	0/9 (0%)		1/10 (10%)		3/36 (8.3%)		1/20 (5%)		0/3 (0%)
Oedema	0/9 (0%)		0/10 (0%)		1/36 (2.8%)		1/20 (5%)		0/3 (0%)
Oedema peripheral	2/9 (22.2%)		0/10 (0%)		2/36 (5.6%)		2/20 (10%)		0/3 (0%)
Pain	0/9 (0%)		0/10 (0%)		3/36 (8.3%)		0/20 (0%)		1/3 (33.3%)
Performance status decreased	0/9 (0%)		0/10 (0%)		0/36 (0%)		0/20 (0%)		1/3 (33.3%)
Pyrexia	0/9 (0%)		2/10 (20%)		13/36 (36.1%)		8/20 (40%)		1/3 (33.3%)
Hepatobiliary disorders
Hyperbilirubinaemia	0/9 (0%)		1/10 (10%)		2/36 (5.6%)		0/20 (0%)		0/3 (0%)
Infections and infestations
Bronchitis	0/9 (0%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Conjunctivitis	1/9 (11.1%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Cystitis	0/9 (0%)		1/10 (10%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Folliculitis	1/9 (11.1%)		0/10 (0%)		1/36 (2.8%)		0/20 (0%)		0/3 (0%)
Gastroenteritis viral	1/9 (11.1%)		0/10 (0%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Herpes zoster	0/9 (0%)		1/10 (10%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Lung infection	0/9 (0%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Nail infection	0/9 (0%)		0/10 (0%)		2/36 (5.6%)		0/20 (0%)		0/3 (0%)
Paronychia	0/9 (0%)		0/10 (0%)		2/36 (5.6%)		0/20 (0%)		0/3 (0%)
Pharyngitis	0/9 (0%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Sinusitis	1/9 (11.1%)		0/10 (0%)		1/36 (2.8%)		0/20 (0%)		0/3 (0%)
Skin infection	1/9 (11.1%)		1/10 (10%)		1/36 (2.8%)		0/20 (0%)		0/3 (0%)
Tinea cruris	1/9 (11.1%)		0/10 (0%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Tooth abscess	0/9 (0%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Upper respiratory tract infection	0/9 (0%)		2/10 (20%)		1/36 (2.8%)		1/20 (5%)		0/3 (0%)
Vaginal infection	0/9 (0%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Viral upper respiratory tract infection	0/9 (0%)		1/10 (10%)		1/36 (2.8%)		0/20 (0%)		0/3 (0%)
Injury, poisoning and procedural complications
Fall	0/9 (0%)		0/10 (0%)		1/36 (2.8%)		1/20 (5%)		0/3 (0%)
Gastrointestinal stoma complication	1/9 (11.1%)		0/10 (0%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Infusion related reaction	3/9 (33.3%)		3/10 (30%)		12/36 (33.3%)		7/20 (35%)		1/3 (33.3%)
Pelvic fracture	0/9 (0%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Investigations
Alanine aminotransferase increased	1/9 (11.1%)		2/10 (20%)		4/36 (11.1%)		1/20 (5%)		0/3 (0%)
Aspartate aminotransferase increased	1/9 (11.1%)		2/10 (20%)		5/36 (13.9%)		1/20 (5%)		1/3 (33.3%)
Blood alkaline phosphatase increased	0/9 (0%)		2/10 (20%)		2/36 (5.6%)		1/20 (5%)		1/3 (33.3%)
Blood bilirubin increased	1/9 (11.1%)		3/10 (30%)		5/36 (13.9%)		5/20 (25%)		1/3 (33.3%)
Blood lactate dehydrogenase increased	0/9 (0%)		0/10 (0%)		0/36 (0%)		0/20 (0%)		1/3 (33.3%)
Blood sodium decreased	0/9 (0%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Electrocardiogram QT prolonged	0/9 (0%)		1/10 (10%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Lymphocyte count decreased	4/9 (44.4%)		1/10 (10%)		3/36 (8.3%)		3/20 (15%)		0/3 (0%)
Platelet count decreased	1/9 (11.1%)		0/10 (0%)		1/36 (2.8%)		1/20 (5%)		0/3 (0%)
Weight decreased	0/9 (0%)		2/10 (20%)		3/36 (8.3%)		1/20 (5%)		0/3 (0%)
White blood cell count decreased	0/9 (0%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Metabolism and nutrition disorders
Decreased appetite	2/9 (22.2%)		3/10 (30%)		9/36 (25%)		5/20 (25%)		0/3 (0%)
Dehydration	2/9 (22.2%)		2/10 (20%)		4/36 (11.1%)		3/20 (15%)		0/3 (0%)
Hyperglycaemia	1/9 (11.1%)		0/10 (0%)		1/36 (2.8%)		0/20 (0%)		0/3 (0%)
Hypokalaemia	1/9 (11.1%)		2/10 (20%)		5/36 (13.9%)		4/20 (20%)		0/3 (0%)
Hypomagnesaemia	1/9 (11.1%)		4/10 (40%)		10/36 (27.8%)		5/20 (25%)		0/3 (0%)
Hyponatraemia	0/9 (0%)		1/10 (10%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Hypophosphataemia	1/9 (11.1%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Iron deficiency	0/9 (0%)		1/10 (10%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Lactic acidosis	0/9 (0%)		0/10 (0%)		0/36 (0%)		0/20 (0%)		1/3 (33.3%)
Malnutrition	0/9 (0%)		1/10 (10%)		1/36 (2.8%)		0/20 (0%)		0/3 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/9 (11.1%)		0/10 (0%)		0/36 (0%)		2/20 (10%)		0/3 (0%)
Back pain	2/9 (22.2%)		2/10 (20%)		5/36 (13.9%)		1/20 (5%)		0/3 (0%)
Flank pain	0/9 (0%)		1/10 (10%)		1/36 (2.8%)		1/20 (5%)		0/3 (0%)
Muscle spasms	0/9 (0%)		0/10 (0%)		4/36 (11.1%)		0/20 (0%)		0/3 (0%)
Muscular weakness	0/9 (0%)		0/10 (0%)		3/36 (8.3%)		0/20 (0%)		0/3 (0%)
Musculoskeletal chest pain	0/9 (0%)		1/10 (10%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Musculoskeletal pain	0/9 (0%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Myalgia	2/9 (22.2%)		0/10 (0%)		3/36 (8.3%)		1/20 (5%)		0/3 (0%)
Neck pain	1/9 (11.1%)		0/10 (0%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain	1/9 (11.1%)		2/10 (20%)		0/36 (0%)		2/20 (10%)		0/3 (0%)
Nervous system disorders
Cerebral infarction	0/9 (0%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Dizziness	1/9 (11.1%)		1/10 (10%)		3/36 (8.3%)		2/20 (10%)		0/3 (0%)
Dysaesthesia	0/9 (0%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Dysgeusia	0/9 (0%)		0/10 (0%)		2/36 (5.6%)		1/20 (5%)		0/3 (0%)
Headache	2/9 (22.2%)		2/10 (20%)		17/36 (47.2%)		8/20 (40%)		1/3 (33.3%)
Presyncope	0/9 (0%)		1/10 (10%)		1/36 (2.8%)		0/20 (0%)		0/3 (0%)
Restless legs syndrome	0/9 (0%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Somnolence	1/9 (11.1%)		0/10 (0%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Syncope	0/9 (0%)		0/10 (0%)		1/36 (2.8%)		1/20 (5%)		0/3 (0%)
Tremor	0/9 (0%)		0/10 (0%)		1/36 (2.8%)		1/20 (5%)		0/3 (0%)
Psychiatric disorders
Anxiety	0/9 (0%)		0/10 (0%)		2/36 (5.6%)		0/20 (0%)		0/3 (0%)
Confusional state	1/9 (11.1%)		0/10 (0%)		1/36 (2.8%)		0/20 (0%)		0/3 (0%)
Depression	1/9 (11.1%)		1/10 (10%)		0/36 (0%)		4/20 (20%)		0/3 (0%)
Insomnia	0/9 (0%)		0/10 (0%)		2/36 (5.6%)		3/20 (15%)		0/3 (0%)
Mental disorder	0/9 (0%)		0/10 (0%)		0/36 (0%)		0/20 (0%)		1/3 (33.3%)
Restlessness	0/9 (0%)		0/10 (0%)		1/36 (2.8%)		1/20 (5%)		0/3 (0%)
Renal and urinary disorders
Dysuria	0/9 (0%)		0/10 (0%)		2/36 (5.6%)		0/20 (0%)		0/3 (0%)
Haematuria	1/9 (11.1%)		0/10 (0%)		2/36 (5.6%)		2/20 (10%)		0/3 (0%)
Hydronephrosis	0/9 (0%)		0/10 (0%)		2/36 (5.6%)		0/20 (0%)		0/3 (0%)
Pollakiuria	0/9 (0%)		0/10 (0%)		1/36 (2.8%)		1/20 (5%)		1/3 (33.3%)
Urinary hesitation	0/9 (0%)		0/10 (0%)		1/36 (2.8%)		1/20 (5%)		0/3 (0%)
Urinary retention	0/9 (0%)		1/10 (10%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	0/9 (0%)		0/10 (0%)		5/36 (13.9%)		4/20 (20%)		0/3 (0%)
Dysphonia	1/9 (11.1%)		0/10 (0%)		2/36 (5.6%)		0/20 (0%)		0/3 (0%)
Dyspnoea	1/9 (11.1%)		1/10 (10%)		11/36 (30.6%)		3/20 (15%)		0/3 (0%)
Dyspnoea exertional	0/9 (0%)		0/10 (0%)		2/36 (5.6%)		0/20 (0%)		0/3 (0%)
Epistaxis	0/9 (0%)		0/10 (0%)		2/36 (5.6%)		1/20 (5%)		0/3 (0%)
Haemoptysis	0/9 (0%)		0/10 (0%)		1/36 (2.8%)		1/20 (5%)		0/3 (0%)
Hypoxia	0/9 (0%)		1/10 (10%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Interstitial lung disease	0/9 (0%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Laryngeal haemorrhage	0/9 (0%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Nasal congestion	1/9 (11.1%)		0/10 (0%)		2/36 (5.6%)		0/20 (0%)		0/3 (0%)
Pulmonary congestion	0/9 (0%)		0/10 (0%)		1/36 (2.8%)		1/20 (5%)		0/3 (0%)
Pulmonary haemorrhage	0/9 (0%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Rhinitis allergic	0/9 (0%)		0/10 (0%)		2/36 (5.6%)		2/20 (10%)		0/3 (0%)
Wheezing	0/9 (0%)		0/10 (0%)		2/36 (5.6%)		0/20 (0%)		0/3 (0%)
Skin and subcutaneous tissue disorders
Acne	0/9 (0%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Dermatitis acneiform	4/9 (44.4%)		5/10 (50%)		14/36 (38.9%)		6/20 (30%)		0/3 (0%)
Dry skin	6/9 (66.7%)		3/10 (30%)		8/36 (22.2%)		10/20 (50%)		0/3 (0%)
Hyperhidrosis	0/9 (0%)		0/10 (0%)		1/36 (2.8%)		0/20 (0%)		1/3 (33.3%)
Ingrowing nail	1/9 (11.1%)		0/10 (0%)		0/36 (0%)		0/20 (0%)		0/3 (0%)
Night sweats	0/9 (0%)		0/10 (0%)		2/36 (5.6%)		0/20 (0%)		0/3 (0%)
Pruritus	2/9 (22.2%)		1/10 (10%)		7/36 (19.4%)		2/20 (10%)		0/3 (0%)
Rash	0/9 (0%)		1/10 (10%)		7/36 (19.4%)		2/20 (10%)		0/3 (0%)
Rash maculo-papular	2/9 (22.2%)		3/10 (30%)		7/36 (19.4%)		5/20 (25%)		1/3 (33.3%)
Rash papular	0/9 (0%)		0/10 (0%)		3/36 (8.3%)		0/20 (0%)		0/3 (0%)
Rash pruritic	0/9 (0%)		0/10 (0%)		4/36 (11.1%)		0/20 (0%)		0/3 (0%)
Urticaria	0/9 (0%)		0/10 (0%)		1/36 (2.8%)		1/20 (5%)		0/3 (0%)
Vascular disorders
Deep vein thrombosis	1/9 (11.1%)		0/10 (0%)		1/36 (2.8%)		0/20 (0%)		0/3 (0%)
Flushing	0/9 (0%)		0/10 (0%)		1/36 (2.8%)		1/20 (5%)		0/3 (0%)
Hypertension	1/9 (11.1%)		0/10 (0%)		0/36 (0%)		2/20 (10%)		0/3 (0%)
Hypotension	0/9 (0%)		0/10 (0%)		2/36 (5.6%)		1/20 (5%)		1/3 (33.3%)
Jugular vein thrombosis	0/9 (0%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)
Raynaud's phenomenon	0/9 (0%)		0/10 (0%)		0/36 (0%)		1/20 (5%)		0/3 (0%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years

Results Point of Contact

Name/Title	Gilead Clinical Study Information Center
Organization	Gilead Sciences
Phone	1-833-445-3230 (GILEAD-0)
Email	GileadClinicalTrials@gilead.com

Responsible Party:

Gilead Sciences

ClinicalTrials.gov Identifier:

NCT02953782

Other Study ID Numbers:

5F9004

First Posted:

Nov 3, 2016

Last Update Posted:

Mar 1, 2021

Last Verified:

Feb 1, 2021

Study of Magrolimab (Hu5F9-G4) in Combination With Cetuximab in Participants With Solid Tumors and Advanced Colorectal Cancer

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