Recruiting
Phase 1

COM503

Sponsor:

Compugen Ltd

Code:

NCT06759649

Conditions

Neoplasm

Cancer, Malignant Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

COM503

Zimberelimab

Study Details

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

Study ID

NCT06759649

Start date

Jan 7, 2025

Status verified date

Sep, 2025

Completion date

Nov 22, 2027

Anticipated

Primary completion date

Nov 22, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1, A-1

Monotherapy Dose Escalation

experimental: Part 1, A-2

Backfill

experimental: Part 1, B

Dose escalation, COM503 in combination with a fixed dose of zimberelimab.

experimental: Part 2, A

Dose expansion, COM503 monotherapy

experimental: Part 2, B

Dose expansion, COM503 in combination with a fixed dose of zimberelimab.

Interventions

COM503

Intravenous Infusion

Zimberelimab

Intravenous infusion

Primary outcome measure

  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Michelle Chief Medical Officer, MD

+14153734034michellebm@cgen.com

Locations

Yale- New Haven Hospital- Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Study Coordinator

2038154124omowunmi.afolabi@yale.edu

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 0221502215

Contacts

6179757423aposner1@bidmc.harvard.edu

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

Manish Sharma

6169545554manish.sharma@startmidwest.com

The West Clinic, PLCC dba West Cancer Center

Recruiting

Germantown, Tennessee, United States, 38138

Contacts

Manager of Phase 1 Research

9016830055nholloway@westclinic.com

NEXT Oncology San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

David Sommerhalder

2105809500dsommerhalder@nextoncology.com

START- San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

HOPE Team Primary Site Contact

210-593-5250hopeteam@startresearch.com

Principal Investigator:

Drew Rasco

NEXT Oncology Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Mohammed Salkeni

7037834510msalkeni@nextoncology.com

More Information

Sponsor

Compugen Ltd

Last update posted

Aug 12, 2026

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Compugen Ltd on 2026-08-12.