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

February 26, 2026 updated by: Compugen Ltd

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Michelle Chief Medical Officer, MD
  • Phone Number: +14153734034
  • Email: michellebm@cgen.com

Study Locations

  • Israel
    • Israel
      • Haifa, Israel, Israel, 3109601
      • Jerusalem, Israel, Israel, 9112001
        • Recruiting
        • Hadassah University Medical Center- Ein Kerem
        • Contact:
      • Petah Tikva, Israel, Israel, 4941492
        • Recruiting
        • Rabin Medical Center
        • Contact:
      • Ramat Gan, Israel, Israel, 5465601
  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale- New Haven Hospital- Yale Cancer Center
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 0221502215
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • The West Clinic, PLCC dba West Cancer Center
        • Contact:
    • Texas
      • San Antonio, Texas, United States, 78229
      • San Antonio, Texas, United States, 78229
    • Virginia
      • Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1, A-1
Monotherapy Dose Escalation
Drug: COM503
Intravenous Infusion
Experimental: Part 1, A-2
Backfill
Drug: COM503
Intravenous Infusion
Experimental: Part 1, B
Dose escalation, COM503 in combination with a fixed dose of zimberelimab.
Drug: COM503
Intravenous Infusion
Drug: Zimberelimab
Intravenous infusion
Experimental: Part 2, A
Dose expansion, COM503 monotherapy
Drug: COM503
Intravenous Infusion
Experimental: Part 2, B
Dose expansion, COM503 in combination with a fixed dose of zimberelimab.
Drug: COM503
Intravenous Infusion
Drug: Zimberelimab
Intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the safety profile of COM503 as monotherapy in participants with advanced malignancies.
Time Frame: 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.
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.
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Compugen Ltd

Collaborators

Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2025

Primary Completion (Estimated)

November 22, 2027

Study Completion (Estimated)

November 22, 2027

Study Registration Dates

First Submitted

December 19, 2024

First Submitted That Met QC Criteria

December 29, 2024

First Posted (Actual)

January 6, 2025

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPG-05-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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