> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-clinical-trial-to-assess-com503-in-participants-with-c9dd162b-c684-4ff9-8120-261fe1a30966 > Record changed: 2026-10-13 # A Clinical Trial to Assess COM503 in Participants With Advanced Solid Malignancies NCT06759649 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) Participants 200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) Lead sponsor Compugen Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) Start date 2025-01-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) Number of sites 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) **Short title** A Clinical Trial to Assess COM503 in Participants With Advanced Solid Malignancies Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) ## Dates **Completion date** 2027-11-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) **First posted** 2025-01-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) **Registry last updated** 2026-08-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) **Primary completion date** 2027-11-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) **Start date** 2025-01-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) ## Size and sites **Participants** 200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) **Planned participants** 200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) **Number of sites** 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) **Lead sponsor** Compugen Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) ## Identifiers **Registry ID** NCT06759649 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) **ClinicalTrials.gov ID** NCT06759649 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) ## Outcomes ### Primary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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 - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06759649) ## Related records ### Drugs (1) - [Zimberelimab](https://trialight.com/data/asset/zimberelimab-0723178b-0f17-47bf-bdaa-1046f372b9d2.md) ### Collaborators (1) - [Gilead Sciences](https://trialight.com/data/company/gilead-sciences-dc2ce801-6c14-47ef-b8fc-217ce33be039.md) ### Lead sponsors (1) - [Compugen Ltd](https://trialight.com/data/company/compugen-ltd-5fb8d94a-2e33-44d5-8e62-bac1164bf7eb.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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