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NCT06759649PHASE1Recruiting

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

Compugen Ltd

Start Date

1/7/2025

Completion Date

11/22/2027

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

COM503

DRUG

Zimberelimab

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Conditions

NeoplasmCancer, Malignant Tumors

Locations

Yale- New Haven Hospital- Yale Cancer Center

New Haven, Connecticut 06510

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 0221502215

United States

START Midwest

Grand Rapids, Michigan 49546

United States

The West Clinic, PLCC dba West Cancer Center

Germantown, Tennessee 38138

United States

NEXT Oncology San Antonio

San Antonio, Texas 78229

United States

START

San Antonio, Texas 78229

United States

NEXT Oncology Virginia

Fairfax, Virginia 22031

United States

Rambam Health Care Campus

Haifa, Israel 3109601

Israel

Hadassah University Medical Center- Ein Kerem

Jerusalem, Israel 9112001

Israel

Rabin Medical Center

Petah Tikva, Israel 4941492

Israel

The Chaim Sheba Medical Center

Ramat Gan, Israel 5465601

Israel