A Clinical Trial to Assess COM503 in Participants With Ad... | NCT06759649

Status Module

Name	Class
Gilead Sciences	INDUSTRY

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Part 1, A-1	Experimental	Monotherapy Dose Escalation	Drug: COM503
Part 1, A-2	Experimental	Backfill	Drug: COM503
Part 1, B	Experimental	Dose escalation, COM503 in combination with a fixed dose of zimberelimab.	Drug: COM503 Drug: Zimberelimab
Part 2, A	Experimental	Dose expansion, COM503 monotherapy	Drug: COM503
Part 2, B	Experimental	Dose expansion, COM503 in combination with a fixed dose of zimberelimab.	Drug: COM503 Drug: Zimberelimab

Name	Type	Description	Arm Group Labels	Other Names
COM503	Drug	Intravenous Infusion	Part 1, A-1 Part 1, A-2 Part 1, B Part 2, A Part 2, B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the safety profile of COM503 as monotherapy in participants with advanced malignancies.	Number of participants in monotherapy cohorts with treatment-related adverse events as assessed by CTCAE v4.0	from the first dose of COM503 to the earlier of 90 days following the last dose of COM503 and/or zimberelimab or start of a new anticancer therapy.
To evaluate the safety profile of COM503 as monotherapy in participants with advanced malignancies.	Number of participants in monotherapy cohorts with treatment-related serious adverse events as assessed by CTCAE v4.0	from the first dose of COM503 to the earlier of 90 days following the last dose of COM503 and/or zimberelimab or start of a new anticancer therapy.
To evaluate the safety profile of COM503 in combination with zimberelimab in participants with advanced malignancies	Number of participants in combination cohorts with treatment-related adverse events as assessed by CTCAE v4.	from the first dose of COM503 in combination with zimberelimab to the earlier of 90 days following the last dose of COM503 and/or zimberelimab or start of a new anticancer therapy.
To evaluate the safety profile of COM503 in combination with zimberelimab in participants with advanced malignancies	Number of participants in combination cohorts with treatment-related serious adverse events as assessed by CTCAE v4.	from the first dose of COM503 to the earlier of 90 days following the last dose of COM503 and/or zimberelimab or start of a new anticancer therapy.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants with histologically/cytologically confirmed advanced recurrent or metastatic solid tumor malignancy
Part 1 (dose escalation): Participants must have had disease progression on or following all available standard of care (SOC) therapies known to confer clinical benefit.
Part 2 (dose expansion): Participants may be enrolled following disease progression that has progressed after at least 1 available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized SOC.
Participants must have a solid tumor measurable by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria by investigator assessment

Exclusion Criteria:

History of another malignancy within 2 years prior to the first trial intervention administration (unless the malignancy was treated with curative intent with low risk of recurrence [e.g., nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar] which are allowed to enroll).
Therapy with Immunosuppressive doses of systemic medications, such as steroids (doses >10 mg/day prednisone or equivalent daily) within 2 weeks before trial intervention administration
Have known active central nervous system (CNS) metastases and/or leptomeningeal disease (LMD).
Active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires systemic antibiotics, antifungals, or antivirals, respectively.
Ascites or pleural effusion that is symptomatic and/or requiring drainage within 2 weeks prior to the first trial intervention administration.
Have active hepatitis B virus (HBV) or hepatitis C virus (HCV), or participants with human immunodeficiency virus (HIV).
Any medical condition that, in the investigator's or sponsor's opinion, poses an undue risk to the participant's participation in the trial.