Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 1

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

NCT ID: NCT06759649Sponsor: Compugen LtdLast updated: 2026-02-27

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.

Arms & interventions

  • DrugCOM503

    Intravenous Infusion

  • DrugZimberelimab

    Intravenous infusion

Outcome measures

Primary

  • 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.

  • 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.

  • 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.

  • 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.

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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: * 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 locations (7)

Yale- New Haven Hospital- Yale Cancer Center

New Haven, Connecticut, 06510

Recruiting
Study Coordinator · Contact

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 0221502215

Recruiting

START Midwest

Grand Rapids, Michigan, 49546

Recruiting

The West Clinic, PLCC dba West Cancer Center

Germantown, Tennessee, 38138

Recruiting
Manager of Phase 1 Research · Contact

NEXT Oncology San Antonio

San Antonio, Texas, 78229

Recruiting
David Sommerhalder · Contact

START

San Antonio, Texas, 78229

Recruiting
Drew Rasco · Contact

NEXT Oncology Virginia

Fairfax, Virginia, 22031

Recruiting
Mohammed Salkeni · Contact