PROCLAIM: CX-072-002: Study of PD-L1 Probody Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors

• Sponsor: CytomX Therapeutics (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03993379
• Collaborator: (none)
• Enrollment: 3
• Locations: 27
• Arms: 4
• Actual Duration (Months): 6
• Patients Per Site: 0.1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

To obtain evidence of antitumor effect of CX-072 in combination with anticancer therapy in adult patients with solid tumor based upon overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST)

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor; Unresectable or Metastatic Melanoma	Drug: CX-072; Drug: Ipilimumab	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Open-Label, Multi-cohort Study of PD-L1 Probody Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors
• Actual Study Start Date: Nov 20, 2019
• Actual Primary Completion Date: May 21, 2020
• Actual Study Completion Date: May 21, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CX-072 in combination with anti-cancer therapy-front line histologically or cytologically confirmed solid tumor who have received no prior treatment	Drug: CX-072; CX-072 in combination with ipilimumab
Experimental: CX-072 in combination with ipilimumab histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma who have experienced progressive disease or relapse following treatment with a PD-1/PD-L1 immune checkpoint inhibitor	Drug: CX-072; CX-072 in combination with ipilimumab; Drug: Ipilimumab; CX-072 in combination with ipilimumab
Experimental: CX-072 in combination with anti-cancer therapy-Progressed histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy	Drug: CX-072; CX-072 in combination with ipilimumab
Experimental: CX-072 in combination with anti-cancer therapy-Neoadjuvant neo-adjuvant study in subjects with histologically confirmed solid tumor	Drug: CX-072; CX-072 in combination with ipilimumab

Outcome Measures

Primary Outcome Measures

1. Overall Response Rate by RECIST v 1.1 [1 year]

   ORR by RECIST v1.1

Secondary Outcome Measures

1. The Percentage of Patients Experiencing Treatment Related Adverse Events [2 years]

   Safety and Tolerability of CX-072 in Combination Therapy

2. The Numbers of Patients Experiencing Anti-tumor Activity by irRECIST [2 years]

   ORR by irRECIST

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. At least 18 years of age

2. Measurable disease as defined by RECIST v1.1

3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

4. Agree to provide tumor tissue and blood samples for biomarker assessment

Exclusion Criteria:

1. Treatment with cytotoxic chemotherapy, biologic agents, radiation, immunotherapy, or any investigational agent within 28 days prior to the first dose of study treatment.

2. Prior therapy with a chimeric antigen receptor T cell-containing regimen

3. History of active autoimmune disease(s) including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies, type 1 insulin-dependent diabetes mellitus

4. History of myocarditis regardless of the cause

5. History of intolerance to prior checkpoint inhibitor therapy defined as the need to discontinue treatment due to an irAE

6. History of any syndrome or medical condition that required treatment with systemic steroids (≥10 mg daily prednisone equivalents) or immunosuppressive medications.

7. History of severe allergic or anaphylactic reactions to human mAb therapy or known hypersensitivity to any Probody therapeutic

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope National Medical Center	Duarte	California	United States	91010
2	The Angeles Clinic and Research Institute	Los Angeles	California	United States	90025
3	Beacon Cancer Care	Coeur d'Alene	Idaho	United States	83814
4	University of Chicago	Chicago	Illinois	United States	60637
5	Norton Cancer Institute	Louisville	Kentucky	United States	40202
6	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02215
7	NYC Cancer Institute	New York	New York	United States	10016
8	Columbia Medical Center	New York	New York	United States	10032
9	Oregon Health & Science Center	Portland	Oregon	United States	97210
10	Providence Portland Medical Center	Portland	Oregon	United States	97213
11	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania	United States	15232
12	Inova Dwight and March Schar Cancer Institute	Fairfax	Virginia	United States	22031
13	Virginia Cancer Specialists	Fairfax	Virginia	United States	22031
14	Multicare Institute for Research and Innovation	Spokane	Washington	United States	99204
15	Sunshine Coast University Private Hospital	Sunshine Coast	Queensland	Australia
16	Ballarat Oncology and Haematology Services	Wendouree	Victoria	Australia
17	Asan Medical Center	Seoul		Korea, Republic of
18	Samsung Medical Center	Seoul		Korea, Republic of
19	Seoul National University Hospital	Seoul		Korea, Republic of
20	Severance Hospital Yonsei University Health System	Seoul		Korea, Republic of
21	The Netherlands Cancer Institute	Amsterdam		Netherlands
22	University Medical Center Groningen	Groningen		Netherlands
23	ICO Hospitalet, Hospital Duran I Reynals	Barcelona		Spain	08908
24	Hospital Clinic de Barcelona. Servicio Oncologia Medica	Barcelona		Spain
25	Hospital Universitario La Paz	Madrid		Spain
26	START- Madrid	Madrid		Spain
27	Clinica Universitaria de Navarra	Pamplona		Spain

Sponsors and Collaborators

• CytomX Therapeutics

Investigators

• Study Director: Lawrence Lu, MD, CytomX Therapeutics

Study Documents (Full-Text)

• Study Protocol - Aug 21, 2019

More Information

Publications

None provided.

• Responsible Party: CytomX Therapeutics
• ClinicalTrials.gov Identifier: NCT03993379
• Other Study ID Numbers: CTMX-M-072-002
• First Posted: Jun 20, 2019
• Last Update Posted: Dec 1, 2021
• Last Verified: Nov 1, 2021

• 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
• Keywords provided by CytomX Therapeutics: Combination; ipilimumab; Cancer; checkpoint inhibitor; PD-L1; CTLA-4; PROCLAIM; PROCLAIM-CX-072; Relapsed; Refractory
• Additional relevant MeSH terms: Neoplasms; Melanoma; Ipilimumab

Study Results

Participant Flow

Recruitment Details	This study was composed of 2 parts (Part A and Part B) and 4 cohorts (A1, A2, A3, B1).
Pre-assignment Detail	Subjects who meet Inclusion / Exclusion criteria began the Screening Period within 30 days prior to the first dose of study treatment. Subjects for whom consent was provided underwent Screening Period assessments to determine eligibility for the study; assessments were to be performed within 30 days prior to the first dose of study treatment.

Arm/Group Title	Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line	Cohort A2: CX-072 in Combination With Ipilimumab	Cohort A3: CX-072 in Combination With Anti-cancer Therapy-Progressed	Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant
Arm/Group Description	Histologically or cytologically confirmed solid tumor who have received no prior treatment CX-072 in combination with ipilimumab Part A Dosing Regimen: Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w Monotherapy treatment: 800 mg CX-072, q2w	Histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma who have experienced progressive disease or relapse following treatment with a PD-1/PD-L1 immune checkpoint inhibitor CX-072 in combination with ipilimumab Part A Dosing Regimen: Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w Monotherapy treatment: 800 mg CX-072, q2w	Histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy CX-072 in combination with ipilimumab Part A Dosing Regimen: Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w Monotherapy treatment: 800 mg CX-072, q2w	Neo-adjuvant study in subjects with histologically confirmed solid tumor CX-072 in combination with ipilimumab Part B Dosing Regimen: Combination treatment: 800 mg CX-072 + 1 mg/kg ipilimumab, q3w Monotherapy treatment: 800 mg CX-072, q2w
Period Title: Overall Study
STARTED	0	3	0	0
COMPLETED	0	0	0	0
NOT COMPLETED	0	3	0	0

Baseline Characteristics

Arm/Group Title	Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line	Cohort A2: CX-072 in Combination With Ipilimumab	Cohort A3: CX-072 in Combination With Anti-cancer Therapy-Progressed	Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant	Total
Arm/Group Description	Histologically or cytologically confirmed solid tumor who have received no prior treatment CX-072 in combination with ipilimumab Part A Dosing Regimen: Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w Monotherapy treatment: 800 mg CX-072, q2w	Histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma who have experienced progressive disease or relapse following treatment with a PD-1/PD-L1 immune checkpoint inhibitor CX-072 in combination with ipilimumab Part A Dosing Regimen: Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w Monotherapy treatment: 800 mg CX-072, q2w	Histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy CX-072 in combination with ipilimumab Part A Dosing Regimen: Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w Monotherapy treatment: 800 mg CX-072, q2w	Neo-adjuvant study in subjects with histologically confirmed solid tumor CX-072 in combination with ipilimumab Part B Dosing Regimen: Combination treatment: 800 mg CX-072 + 1 mg/kg ipilimumab, q3w Monotherapy treatment: 800 mg CX-072, q2w	Total of all reporting groups
Overall Participants	0	3	0	0	3
Age (Count of Participants)
<=18 years	0 NaN	0 0%	0 NaN	0 NaN	0 0%
Between 18 and 65 years	0 NaN	1 33.3%	0 NaN	0 NaN	1 33.3%
>=65 years	0 NaN	2 66.7%	0 NaN	0 NaN	2 66.7%
Sex: Female, Male (Count of Participants)
Female	0 NaN	1 33.3%	0 NaN	0 NaN	1 33.3%
Male	0 NaN	2 66.7%	0 NaN	0 NaN	2 66.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 NaN	0 0%
Asian	1 Infinity	1 33.3%
Native Hawaiian or Other Pacific Islander	0 NaN	0 0%
Black or African American	0 NaN	0 0%
White	2 Infinity	2 66.7%
More than one race	0 NaN	0 0%
Unknown or Not Reported	0 NaN	0 0%
Region of Enrollment (participants) [Number]
Netherlands	0 NaN	0 0%
South Korea	0 NaN	0 0%
United States	3 Infinity	3 100%
Australia	0 NaN	0 0%
Spain	0 NaN	0 0%

Outcome Measures

1. Primary Outcome

Title	Overall Response Rate by RECIST v 1.1
Description	ORR by RECIST v1.1
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

All subjects who have at least one measurable lesion at baseline, receive at least 1 infusion of CX-072 DP and have at least 1 postbaseline RECIST 1.1 assessment, or who discontinue treatment/study due to disease progression by RECIST v 1.1.

Arm/Group Title	Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line	Cohort A2: CX-072 in Combination With Ipilimumab	Cohort A3: CX-072 in Combination With Anti-cancer Therapy-Progressed	Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant
Arm/Group Description	Histologically or cytologically confirmed solid tumor who have received no prior treatment CX-072 in combination with ipilimumab Part A Dosing Regimen: Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w Monotherapy treatment: 800 mg CX-072, q2w	Histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma who have experienced progressive disease or relapse following treatment with a PD-1/PD-L1 immune checkpoint inhibitor CX-072 in combination with ipilimumab Part A Dosing Regimen: Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w Monotherapy treatment: 800 mg CX-072, q2w	Histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy CX-072 in combination with ipilimumab Part A Dosing Regimen: Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w Monotherapy treatment: 800 mg CX-072, q2w	Neo-adjuvant study in subjects with histologically confirmed solid tumor CX-072 in combination with ipilimumab Part B Dosing Regimen: Combination treatment: 800 mg CX-072 + 1 mg/kg ipilimumab, q3w Monotherapy treatment: 800 mg CX-072, q2w
Measure Participants	0	2	0	0
Complete Response (CR)	0 NaN	0 0%	0 NaN	0 NaN
Partial Response (PR)	0 NaN	0 0%	0 NaN	0 NaN
Stable Disease (SD)	0 NaN	0 0%	0 NaN	0 NaN
Progressive Disease (PD)	0 NaN	2 66.7%	0 NaN	0 NaN

2. Secondary Outcome

Title	The Percentage of Patients Experiencing Treatment Related Adverse Events
Description	Safety and Tolerability of CX-072 in Combination Therapy
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

All subjects who receive any amount of CX-072.

Arm/Group Title	Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line	Cohort A2: CX-072 in Combination With Ipilimumab	Cohort A3: CX-072 in Combination With Anti-cancer Therapy-Progressed	Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant
Arm/Group Description	Histologically or cytologically confirmed solid tumor who have received no prior treatment CX-072 in combination with ipilimumab Part A Dosing Regimen: Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w Monotherapy treatment: 800 mg CX-072, q2w	Histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma who have experienced progressive disease or relapse following treatment with a PD-1/PD-L1 immune checkpoint inhibitor CX-072 in combination with ipilimumab Part A Dosing Regimen: Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w Monotherapy treatment: 800 mg CX-072, q2w	Histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy CX-072 in combination with ipilimumab Part A Dosing Regimen: Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w Monotherapy treatment: 800 mg CX-072, q2w	Neo-adjuvant study in subjects with histologically confirmed solid tumor CX-072 in combination with ipilimumab Part B Dosing Regimen: Combination treatment: 800 mg CX-072 + 1 mg/kg ipilimumab, q3w Monotherapy treatment: 800 mg CX-072, q2w
Measure Participants	0	3	0	0
Experienced	0 NaN	1 33.3%	0 NaN	0 NaN
Did not experience	0 NaN	2 66.7%	0 NaN	0 NaN
Experienced	0 NaN	2 66.7%	0 NaN	0 NaN
Did not experience	0 NaN	1 33.3%	0 NaN	0 NaN
Experienced	0 NaN	1 33.3%	0 NaN	0 NaN
Did not experience	0 NaN	2 66.7%	0 NaN	0 NaN
Experienced	0 NaN	1 33.3%	0 NaN	0 NaN
Did not experience	0 NaN	2 66.7%	0 NaN	0 NaN
Experienced	0 NaN	1 33.3%	0 NaN	0 NaN
Did not experience	0 NaN	2 66.7%	0 NaN	0 NaN
Experienced	0 NaN	1 33.3%	0 NaN	0 NaN
Did not experience	0 NaN	2 66.7%	0 NaN	0 NaN

3. Secondary Outcome

Title	The Numbers of Patients Experiencing Anti-tumor Activity by irRECIST
Description	ORR by irRECIST
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

All subjects who have at least one measurable lesion at baseline, receive at least 1 infusion of CX-072 DP and have at least 1 postbaseline irRECIST assessment, or who discontinue treatment/study due to disease progression by irRECIST.

Arm/Group Title	Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line	Cohort A2: CX-072 in Combination With Ipilimumab	Cohort A3: CX-072 in Combination With Anti-cancer Therapy-Progressed	Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant
Arm/Group Description	Histologically or cytologically confirmed solid tumor who have received no prior treatment CX-072 in combination with ipilimumab Part A Dosing Regimen: Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w Monotherapy treatment: 800 mg CX-072, q2w	Histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma who have experienced progressive disease or relapse following treatment with a PD-1/PD-L1 immune checkpoint inhibitor CX-072 in combination with ipilimumab Part A Dosing Regimen: Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w Monotherapy treatment: 800 mg CX-072, q2w	Histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy CX-072 in combination with ipilimumab Part A Dosing Regimen: Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w Monotherapy treatment: 800 mg CX-072, q2w	Neo-adjuvant study in subjects with histologically confirmed solid tumor CX-072 in combination with ipilimumab Part B Dosing Regimen: Combination treatment: 800 mg CX-072 + 1 mg/kg ipilimumab, q3w Monotherapy treatment: 800 mg CX-072, q2w
Measure Participants	0	2	0	0
immune-related Complete Response (irCR)	0 NaN	0 0%	0 NaN	0 NaN
immune-related Partial Response (irPR)	0 NaN	0 0%	0 NaN	0 NaN
immune-related Stable Disease (irSD)	0 NaN	0 0%	0 NaN	0 NaN
immune-related Progressive Disease (irPD)	0 NaN	2 66.7%	0 NaN	0 NaN
no target disease identified at baseline and at follow-up (irNN)	0 NaN	0 0%	0 NaN	0 NaN

Adverse Events

Time Frame	The pre-specified AE reporting period spans from signing of the ICF to 30 days after the last dose. Monitoring continued for immune-related AEs, AEs ≥ Grade 3, and serious AEs (SAEs) up to 90 days following the last dose of the study drug. All AEs are reported from signing of the informed consent through study completion, an average of 4 months.
Adverse Event Reporting Description	All AEs are reported from signing of the informed consent through study completion, regardless of attribution/causality.
Arm/Group Title	Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line		Cohort A2: CX-072 in Combination With Ipilimumab		Cohort A3: CX-072 in Combination With Anti-cancer Therapy-Progressed		Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant
Arm/Group Description	Histologically or cytologically confirmed solid tumor who have received no prior treatment CX-072 in combination with ipilimumab Part A Dosing Regimen: Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w Monotherapy treatment: 800 mg CX-072, q2w		Histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma who have experienced progressive disease or relapse following treatment with a PD-1/PD-L1 immune checkpoint inhibitor CX-072 in combination with ipilimumab Part A Dosing Regimen: Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w Monotherapy treatment: 800 mg CX-072, q2w		Histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy CX-072 in combination with ipilimumab Part A Dosing Regimen: Combination treatment: 800 mg CX-072 + 3 mg/kg ipilimumab, q3w Monotherapy treatment: 800 mg CX-072, q2w		Neo-adjuvant study in subjects with histologically confirmed solid tumor CX-072 in combination with ipilimumab Part B Dosing Regimen: Combination treatment: 800 mg CX-072 + 1 mg/kg ipilimumab, q3w Monotherapy treatment: 800 mg CX-072, q2w
All Cause Mortality
	Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line		Cohort A2: CX-072 in Combination With Ipilimumab		Cohort A3: CX-072 in Combination With Anti-cancer Therapy-Progressed		Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/3 (0%)		0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line		Cohort A2: CX-072 in Combination With Ipilimumab		Cohort A3: CX-072 in Combination With Anti-cancer Therapy-Progressed		Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		1/3 (33.3%)		0/0 (NaN)		0/0 (NaN)
Hepatobiliary disorders
Immune-mediated Hepatitis	0/0 (NaN)		1/3 (33.3%)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Cohort A1: CX-072 in Combination With Anti-cancer Therapy-front Line		Cohort A2: CX-072 in Combination With Ipilimumab		Cohort A3: CX-072 in Combination With Anti-cancer Therapy-Progressed		Cohort B1: CX-072 in Combination With Anti-cancer Therapy-Neoadjuvant
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		3/3 (100%)		0/0 (NaN)		0/0 (NaN)
Gastrointestinal disorders
Diarrhea	0/0 (NaN)		1/3 (33.3%)	1	0/0 (NaN)	1	0/0 (NaN)	1
Nausea	0/0 (NaN)		1/3 (33.3%)	1	0/0 (NaN)	1	0/0 (NaN)	1
Vomitting	0/0 (NaN)		1/3 (33.3%)	1	0/0 (NaN)	1	0/0 (NaN)	1
General disorders
Generalized Oedema	0/0 (NaN)		1/3 (33.3%)	1	0/0 (NaN)	1	0/0 (NaN)	1
Oedema Peripheral	0/0 (NaN)		1/3 (33.3%)	1	0/0 (NaN)	1	0/0 (NaN)	1
Hepatobiliary disorders
Immune-mediated Hepatitis	0/0 (NaN)		2/3 (66.7%)	2	0/0 (NaN)	2	0/0 (NaN)	2
Infections and infestations
Cellulitis	0/0 (NaN)		1/3 (33.3%)	1	0/0 (NaN)	1	0/0 (NaN)	1
Injury, poisoning and procedural complications
Infusion Related Reaction	0/0 (NaN)		1/3 (33.3%)	2	0/0 (NaN)	2	0/0 (NaN)	2
Investigations
Blood Creatinine Increased	0/0 (NaN)		1/3 (33.3%)	1	0/0 (NaN)	1	0/0 (NaN)	1
Metabolism and nutrition disorders
Dehydration	0/0 (NaN)		1/3 (33.3%)	2	0/0 (NaN)	2	0/0 (NaN)	2
Hypokalemia	0/0 (NaN)		1/3 (33.3%)	1	0/0 (NaN)	1	0/0 (NaN)	1
Hypophosphataemia	0/0 (NaN)		1/3 (33.3%)	1	0/0 (NaN)	1	0/0 (NaN)	1
Hyperglycaemia	0/0 (NaN)		1/3 (33.3%)	1	0/0 (NaN)	1	0/0 (NaN)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain	0/0 (NaN)		1/3 (33.3%)	1	0/0 (NaN)	1	0/0 (NaN)	1
Skin and subcutaneous tissue disorders
Rash Generalized	0/0 (NaN)		1/3 (33.3%)	1	0/0 (NaN)	1	0/0 (NaN)	1
Pruritus	0/0 (NaN)		1/3 (33.3%)	1	0/0 (NaN)	1	0/0 (NaN)	1

Limitations/Caveats

Due to developmental strategic reasons and slow enrollment because of the COVID-19 pandemic, the study was terminated early. Three subjects were enrolled, all in Cohort A2. The last subject observation for this study was on 21 May 2020. Since the study terminated early, a statistical analysis plan was not generated.

More Information

Certain Agreements

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