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A Clinical Trial to Assess COM503 in Participants With Advanced Solid Malignancies | Clinical Trials | Clareo Health

RECRUITINGPHASE1

A Clinical Trial to Assess COM503 in Participants With Advanced Solid Malignancies

A First-in-Human, Phase 1 Dose Escalation and Dose Expansion Trial to Assess the Safety and Tolerability of COM503 as Monotherapy and in Combination Therapy in Participants With Advanced Solid Malignancies

NCT06759649•Compugen Ltd

View on ClinicalTrials.gov

Summary

The overall goal of this first-in-human (FIH) clinical trial is to learn about the safety and dosing of COM503 when given alone or in combination with zimberelimab in participants with advanced solid tumors. 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (11)

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

Hadassah University Medical Center- Ein Kerem

Jerusalem, Israel, Israel

Rabin Medical Center

Petah Tikva, Israel, Israel

Key Dates

Start Date

January 7, 2025

Primary Completion Date

November 22, 2027

Completion Date

November 22, 2027

Last Updated

February 27, 2026

Enrollment

200

ESTIMATED participants

Conditions

NeoplasmCancer, Malignant Tumors

Interventions

COM503

DRUG

Zimberelimab

DRUG

Contacts

Michelle Chief Medical Officer, MD

CONTACT

+14153734034 michellebm@cgen.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Clinical Trial to Assess COM503 in Participants With Advanced Solid Malignancies

Inclusion Criteria

Exclusion Criteria

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

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