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NCT Number: NCT06759649

A Clinical Trial to Assess COM503 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.

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Key information

Conditions

Neoplasm Cancer, Malignant Tumors Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rambam Health Care Campus, Haifa, Israel

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

COM503

Drug

Intravenous Infusion

Zimberelimab

Drug

Intravenous infusion

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Michelle Chief Medical Officer, MD

CONTACT

[email protected]

+14153734034

Sponsors and collaborators

Lead sponsor

Compugen Ltd

Industry

Collaborators

  • Gilead Sciences

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 6, 2025
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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