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

NCT06759649
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
200
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Lead sponsor
Compugen Ltd
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Start date
2025-01-07
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Number of sites
11
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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.
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Short title
A Clinical Trial to Assess COM503 in Participants With Advanced Solid Malignancies
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Official 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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-11-22
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First posted
2025-01-06
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Registry last updated
2026-08-12
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Primary completion date
2027-11-22
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Start date
2025-01-07
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Participants
200
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Participant count basis
Estimated
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Planned participants
200
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Protocol amendments
1
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Number of sites
11
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Compugen Ltd
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06759649
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ClinicalTrials.gov ID
NCT06759649
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

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

    Timeframe: 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.

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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.
Sources for eligibility
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  • Yale- New Haven Hospital- Yale Cancer CenterNew Haven, United StatesRecruiting
  • Beth Israel Deaconess Medical CenterBoston, United StatesRecruiting
  • START MidwestGrand Rapids, United StatesRecruiting
  • The West Clinic, PLCC dba West Cancer CenterGermantown, United StatesRecruiting
  • NEXT Oncology San AntonioSan Antonio, United StatesRecruiting
  • START- San AntonioSan Antonio, United StatesRecruiting
  • NEXT Oncology VirginiaFairfax, United StatesRecruiting
  • Rambam Health Care CampusHaifa, IsraelRecruiting
  • Hadassah University Medical Center- Ein KeremJerusalem, IsraelRecruiting
  • Rabin Medical CenterPetah Tikva, IsraelRecruiting
  • The Chaim Sheba Medical CenterRamat Gan, IsraelRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Targets (1)