A Clinical Trial to Assess COM503 in Participants With Advanced Solid Malignancies
NCT ID: NCT06759649
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
200 participants
INTERVENTIONAL
2025-01-07
2027-11-22
Brief Summary
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The primary objectives of this study are:
* To assess the safety and tolerability of COM503 as monotherapy and COM503 in combination with zimberelimab in participants with advanced solid tumors.
* To identify the maximum tolerated dose (MTD) / maximum administered dose (MAD) and/or the recommended phase 2 dose (RP2D) of COM503 as monotherapy and in combination with zimberelimab in participants with advanced solid tumors.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1, A-1
Monotherapy Dose Escalation
COM503
Intravenous Infusion
Part 1, A-2
Backfill
COM503
Intravenous Infusion
Part 1, B
Dose escalation, COM503 in combination with a fixed dose of zimberelimab.
COM503
Intravenous Infusion
Zimberelimab
Intravenous infusion
Part 2, A
Dose expansion, COM503 monotherapy
COM503
Intravenous Infusion
Part 2, B
Dose expansion, COM503 in combination with a fixed dose of zimberelimab.
COM503
Intravenous Infusion
Zimberelimab
Intravenous infusion
Interventions
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COM503
Intravenous Infusion
Zimberelimab
Intravenous infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Compugen Ltd
INDUSTRY
Responsible Party
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Locations
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Yale- New Haven Hospital- Yale Cancer Center
New Haven, Connecticut, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
START Midwest
Grand Rapids, Michigan, United States
The West Clinic, PLCC dba West Cancer Center
Germantown, Tennessee, United States
NEXT Oncology San Antonio
San Antonio, Texas, United States
START
San Antonio, Texas, United States
NEXT Oncology Virginia
Fairfax, Virginia, United States
Rambam Health Care Campus
Haifa, Israel, Israel
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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CPG-05-101
Identifier Type: -
Identifier Source: org_study_id
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