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RecruitingNCT06759649Updated Aug 12, 2026

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

A Phase 1 interventional study of COM503 and Zimberelimab in Neoplasm and Cancer, Malignant Tumors, sponsored by Compugen Ltd. Recruiting at 11 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Compugen Ltd · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Neoplasm
  • Cancer, Malignant Tumors

Browse trials for

Keywords

  • first-in-human
  • oncology
  • monoclonal antibody
  • immunotherapy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Part 1, A-1

    Monotherapy Dose Escalation

    Drug: COM503

  • Experimental
    Part 1, A-2

    Backfill

    Drug: COM503

  • Experimental
    Part 1, B

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

    Drug: COM503 · Drug: Zimberelimab

  • Experimental
    Part 2, A

    Dose expansion, COM503 monotherapy

    Drug: COM503

  • Experimental
    Part 2, B

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

    Drug: COM503 · Drug: Zimberelimab

Interventions

  • DrugCOM503

    Intravenous Infusion

  • DrugZimberelimab

    Intravenous infusion

05

What researchers measure

Primary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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.

    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.

  4. 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.

    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.

06

Study locations

11 of 11 sites recruiting
  • 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
    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
07

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06759649
Lead sponsor
Compugen Ltd
Collaborators
Gilead Sciences
Responsible party
Sponsor
First posted
Jan 6, 2025
Start date
Jan 7, 2025
Primary completion
Nov 22, 2027 (estimated)
Completion
Nov 22, 2027 (estimated)
Last update
Aug 12, 2026

Study contacts

Michelle Chief Medical Officer, MD
Contact
michellebm@cgen.com
+14153734034

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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