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COM503 for Advanced Solid Malignancies

This study is a first-in-human clinical trial testing a new drug called COM503. It aims to understand the safety and correct dosage of COM503 when given alone, or in combination with another drug called zimberelimab, to people with advanced solid cancers (malignancies). The main goal is to see how safe these treatments are. You might be able to join if you have an advanced solid tumor that has progressed after standard treatments. The study plans to enroll about 200 participants.

Study design
This is a first-in-human interventional study, meaning participants will receive the study drugs. It aims to enroll about 200 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety from the first dose of COM503 until 90 days after the last dose of COM503 and/or zimberelimab, or until a new cancer treatment starts.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06759649

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Compugen Ltd
~200 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:COM503Zimberelimab

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the safety profile of COM503 as monotherapy in participants with advanced malignancies.
Measured over 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 more outcomes measured

Conditions

Neoplasm
Cancer, Malignant Tumors

Explore related trials

Solid Neoplasm

NCT06759649

Where you'd take part

This study runs at 11 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Beth Israel Deaconess Medical Center

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Hadassah University Medical Center- Ein Kerem

    Jerusalem, Israel, Israelstudy coordinator listed

    Recruiting

  • NEXT Oncology San Antonio

    San Antonio, Texasstudy coordinator listed

    Recruiting

  • NEXT Oncology Virginia

    Fairfax, Virginiastudy coordinator listed

    Recruiting

  • Rabin Medical Center

    Petah Tikva, Israel, Israelstudy coordinator listed

    Recruiting

  • Rambam Health Care Campus

    Haifa, Israel, Israelstudy coordinator listed

    Recruiting

  • START Midwest

    Grand Rapids, Michiganstudy coordinator listed

    Recruiting

  • START- San Antonio

    San Antonio, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Michelle Chief Medical Officer, MD
[email protected]
+14153734034
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • To evaluate the safety profile of COM503 as monotherapy in participants with advanced malignancies.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

  • To evaluate the safety profile of COM503 as monotherapy in participants with advanced malignancies.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

  • To evaluate the safety profile of COM503 in combination with zimberelimab in participants with advanced malignanciesfrom 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.

  • To evaluate the safety profile of COM503 in combination with zimberelimab in participants with advanced malignanciesfrom 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.