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

NCT06759649 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CPG-05-101
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 11

Brief 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.

Conditions

Neoplasm; Cancer, Malignant Tumors

Keywords

first-in-human; oncology; monoclonal antibody; immunotherapy

Outcome Measures

Primary Outcomes (4)

• 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.

Study Arms (5)

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

Interventions

COM503 DRUG

Intravenous Infusion

Part 1, A-1; Part 1, A-2; Part 1, B; Part 2, A; Part 2, B

Zimberelimab DRUG

Intravenous infusion

Part 1, B; Part 2, B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Compugen Ltd: lead
• Gilead Sciences: collaborator

Study Sites (11)

Yale- New Haven Hospital- Yale Cancer Center

New Haven, Connecticut, 06510, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 0221502215, United States

RECRUITING

START Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

The West Clinic, PLCC dba West Cancer Center

Germantown, Tennessee, 38138, United States

RECRUITING

NEXT Oncology San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

START

San Antonio, Texas, 78229, United States

RECRUITING

NEXT Oncology Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

Rambam Health Care Campus

Haifa, Israel, 3109601, Israel

RECRUITING

Hadassah University Medical Center- Ein Kerem

Jerusalem, Israel, 9112001, Israel

RECRUITING

Rabin Medical Center

Petah Tikva, Israel, 4941492, Israel

RECRUITING

The Chaim Sheba Medical Center

Ramat Gan, Israel, 5465601, Israel

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

zimberelimab

Central Study Contacts

Michelle Chief Medical Officer, MD

CONTACT

+14153734034; michellebm@cgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: January 6, 2025
• Study Start: January 7, 2025
• Primary Completion (Estimated): November 22, 2027
• Study Completion (Estimated): November 22, 2027
• Last Updated: February 27, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

IL (4); US (7)