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Study of Magrolimab in Participants With Solid Tumors

Sponsor
Gilead Sciences (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04827576
Collaborator
(none)
116
Enrollment
25
Locations
4
Arms
41
Anticipated Duration (Months)
4.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objectives of the study are to evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of magrolimab + docetaxel combination therapy in solid tumors (Safety Run-in Cohort 1, Phase 2 Cohorts 1a,

1b, and 1c) and to evaluate the efficacy of magrolimab + docetaxel combination therapy in solid tumors as determined by investigator-assessed objective response rate (ORR) (Phase 2 Cohorts 1a, 1b, and 1c)

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This study will consist of a Safety Run-in Cohort 1 (magrolimab + docetaxel combination).

After completion of the Safety Run-in Cohort 1, Phase 2 Cohort 1 will occur as follows:
  • Phase 2 Cohort 1: a cohort of participants with solid tumors (metastatic non-small cell lung cancer (mNSCLC) (Phase 2 Cohort 1a), metastatic urothelial cancer (mUC) (Phase 2 Cohort 1b), and metastatic small cell lung cancer (mSCLC) (Phase 2 Cohort 1c).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
116 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multi-Arm Study of Magrolimab in Patients With Solid Tumors
Actual Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Safety Run-in Cohort 1, mNSCLC, mUC, mSCLC (Magrolimab + Docetaxel)

Participants with solid tumors (metastatic non-small cell lung cancer (mNSCLC), metastatic urothelial cancer (mUC), metastatic small cell lung cancer (mSCLC)) will receive an escalating dose of magrolimab and docetaxel.

Drug: Magrolimab
Administered intravenously
Other Names:
  • GS-4721

    • Drug: Docetaxel
    Administered intravenously, 75 mg/m^2 on Day 1 of each cycle
    Other Names:
  • Taxotere®

    		•
    Experimental: Phase 2 Cohort 1a, mNSCLC (Magrolimab + Docetaxel)

    Participants with mNSCLC will receive magrolimab at the recommended Phase 2 dose (RP2D) determined in the Safety Run-in Cohort 1 and docetaxel.

    Drug: Magrolimab
    Administered intravenously
    Other Names:
  • GS-4721

    • Drug: Docetaxel
    Administered intravenously, 75 mg/m^2 on Day 1 of each cycle
    Other Names:
  • Taxotere®

    		•
    Experimental: Phase 2 Cohort 1b, mUC (Magrolimab + Docetaxel)

    Participants with mUC will receive magrolimab at the RP2D determined in the Safety Run-in Cohort 1 and docetaxel.

    Drug: Magrolimab
    Administered intravenously
    Other Names:
  • GS-4721

    • Drug: Docetaxel
    Administered intravenously, 75 mg/m^2 on Day 1 of each cycle
    Other Names:
  • Taxotere®

    		•
    Experimental: Phase 2 Cohort 1c, mSCLC (Magrolimab + Docetaxel)

    Participants with mSCLC will receive magrolimab at the RP2D determined in the Safety Run-in Cohort 1 and docetaxel.

    Drug: Magrolimab
    Administered intravenously
    Other Names:
  • GS-4721

    • Drug: Docetaxel
    Administered intravenously, 75 mg/m^2 on Day 1 of each cycle
    Other Names:
  • Taxotere®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Experiencing Adverse Events According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 [First dose date up to 3 years]

    2. Percentage of Participants Experiencing Laboratory Abnormalities According to the NCI CTCAE Version 5.0 [First dose date up to 3 years]

    3. Objective response rate (ORR) (Phase 2 Cohorts 1a, 1b, and 1c) [Up to 6 months]

      ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR), as measured by RECIST version 1.1, as determined by investigator assessment.

    Secondary Outcome Measures

    1. Progression-free Survival (PFS) (Phase 2 Cohorts 1a, 1b, and 1c) [Up to 3 years]

      PFS is defined as the time from the date of dose initiation until the earliest date of documented disease progression, as determined by investigator assessment per RECIST version 1.1, or death from any cause, whichever occurs first.

    2. Duration of Response (DOR) (Phase 2 Cohorts 1a, 1b, and 1c) [Up to 3 years]

      DOR is defined as time from first documentation of CR or PR to the earliest date of documented disease progression, per RECIST version 1.1, or death from any cause, whichever occurs first, as determined by investigator assessment.

    3. Overall Survival (OS) (Phase 2 Cohorts 1a, 1b, and 1c) [Up to 3 years]

      OS is defined as time from date of dose initiation to death from any cause.

    4. Serum Concentration for Magrolimab [Up to end of treatment (approximately 3 years)]

    5. Percentage of Participants who Developed Anti-Magrolimab Antibodies [Up to end of treatment (approximately 3 years)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    • Individual must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

    • Adequate blood counts

    • Adequate renal function

    • Adequate liver function

    • Pretreatment blood cross-match completed

    • Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception

    • Measurable disease according to RECIST version 1.1

    Cohort-Specific Inclusion Criteria:

    • Safety Run-in Cohort 1: Individuals with metastatic advanced solid tumors who have had at least 1 prior line of systemic anticancer therapy (metastatic non-small cell lung cancer (mNSCLC) and metastatic small cell lung cancer (mSCLC)) in a locally advanced/metastatic setting, or 2 prior lines of systemic anticancer therapy (metastatic urothelial cancer(mUC)) in a locally advanced/metastatic setting, and not more than 3 prior lines of systemic anticancer therapy in a locally advanced/metastatic setting.

    • Phase 2 Cohort 1a (mNSCLC): Individuals with NSCLC who have had treatment with platinum-based chemotherapy and/or immune checkpoint inhibitor therapy in a locally advanced/metastatic setting are eligible. At least 1 prior line of systemic anticancer therapy in a locally advanced/metastatic setting is required and not more than 2 prior lines of systemic anticancer therapy in a locally advanced/metastatic setting are allowed. Individuals treated with a taxane within 12 months or individuals refractory to prior taxane treatment are excluded. Individuals who were treated for epidermal growth factor receptor (EGFR), c-ros oncogene 1 (ROS1), anaplastic lymphoma kinase (ALK), neurotrophic tyrosine kinase (NTRK), or mesenchymal-epithelial transition (MET) exon 14 genomic alterations are excluded.

    • Phase 2 Cohort 1b (mUC): Individuals with UC who have had prior treatment with systemic chemotherapy and/or immune checkpoint inhibitor therapy in a locally advanced/metastatic setting are eligible. At least 2 prior lines of systemic anticancer therapy in a locally advanced/metastatic setting are required and not more than 3 prior lines of systemic anticancer therapy in a locally advanced/metastatic setting are allowed. Individuals treated with a taxane within 12 months or individuals refractory to prior taxane treatment are excluded.

    • Phase 2 Cohort 1c (mSCLC): Individuals with SCLC who have had prior treatment with platinum-based chemotherapy and/or immune checkpoint inhibitor therapy are eligible. At least 1 prior line of systemic anticancer therapy in a locally advanced/metastatic setting is required and not more than 2 prior lines of systemic anticancer therapy in a locally advanced/metastatic setting are allowed. Individuals treated with a taxane within 12 months or individuals refractory to prior taxane treatment are excluded.

    Note: Maintenance therapies are not counted as separate lines of therapy.

    Key Exclusion Criteria:

    • Positive serum pregnancy test

    • Breastfeeding female

    • Active central nervous system (CNS) disease. Individuals with asymptomatic and stable, treated CNS lesions (radiation and/or surgery and/or other CNS-directed therapy who have not received corticosteroids for at least 4 weeks) are allowed

    • Red blood cell (RBC) transfusion dependence, defined as requiring more than 2 units of packed red blood cell transfusions during the 4-week period prior to screening. RBC transfusions are permitted during the screening period and prior to enrollment to meet the hemoglobin inclusion criteria

    • History of hemolytic anemia, autoimmune thrombocytopenia, or Evans syndrome in the last 3 months

    • Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient

    • Prior treatment with CD47 or signal regulatory protein alpha-targeting agents

    • Current participation in another interventional clinical trial

    • Known inherited or acquired bleeding disorders

    • Significant disease or medical conditions, as assessed by the investigator and sponsor, that would substantially increase the risk-benefit ratio of participating in the study. This includes, but is not limited to, acute myocardial infarction within the last 6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, and congestive heart failure New York Heart Association Class III-IV

    • Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which individuals are not on active anticancer therapies and who are in complete remission for over 3 years

    • Known active or chronic hepatitis B or C infection or human immunodeficiency virus

    • Prior anticancer therapy including but not limited to chemotherapy, immunotherapy, or investigational agents within 4 weeks prior to magrolimab is not permitted.

    • Note: Localized non-CNS radiotherapy, previous hormonal therapy with luteinizing hormone releasing hormone agonists for prostate or breast cancer, and treatment with bisphosphonates and receptor activator of nuclear factor kappaB ligand (RANKL) inhibitors are not criteria for exclusion.

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UC San Diego Moores Cancer Center La Jolla California United States 92093
    2 Providence Saint John's Health Center Santa Monica California United States 90404
    3 St. Jude Hospital Yorba dba St. Joseph Heritage Healthcare Santa Rosa California United States 95403
    4 Tallahassee Memorial Healthcare Cancer Center Tallahassee Florida United States 32308
    5 University Center and Blood Center,LLC. Athens Georgia United States 30607
    6 Saint Alphonsus Cancer Institute Caldwell Caldwell Idaho United States 83605
    7 Orchard Healthcare Research Inc Skokie Illinois United States 60077
    8 University of Iowa Hospitals & Clinics Iowa City Iowa United States 52242
    9 University of Michigan Ann Arbor Michigan United States 48109
    10 Virginia Piper Cancer Center (Alliant Health) Minneapolis Minnesota United States 55407
    11 Comprehensive Cancer Centers of Nevada- Twain Office Las Vegas Nevada United States 89169
    12 Astera Cancer Care East Brunswick New Jersey United States 08816
    13 Oregon Health & Science University Portland Oregon United States 97239
    14 Charleston Oncology Charleston South Carolina United States 29414
    15 Mary Crowley Cancer Research Dallas Texas United States 75230
    16 MD Anderson Cancer Center Dallas Texas United States 77030
    17 Huntsman Cancer Institute, University of Utah Salt Lake City Utah United States 84112
    18 Medical Oncology Associates,PS (dba Summit Cancer Center) (includes IP Shipment) Spokane Washington United States 99208
    19 Instytut Centrum Zdrowia Matki Polki Lodz Poland 93-513
    20 Wojewodzki Szpital Specjalistyczny w Siedlcach Siedlce Poland 08-110
    21 Hospital Quironsalud Barcelona Barcelona Spain 8023
    22 Hospital De La Santa Creu I Sant Pau Barcelona Spain 8041
    23 Hospital Universitario Virgen Macarena Sevilla Spain 41009
    24 Hospital Universitario Virgen del Rocio Sevilla Spain 41013
    25 Hospital Universitari i Politecnic La Fe Valencia Spain 46026

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    • Study Director: Gilead Study Director, Gilead Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT04827576
    Other Study ID Numbers:
    • GS-US-548-5918
    • 2020-005265-14
    First Posted:
    Apr 1, 2021
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms
    Docetaxel
    Magrolimab

    Study Results

    No Results Posted as of Aug 25, 2022