Assessing COM503 for advanced solid tumors

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

This study is testing a new treatment called COM503, alone and with another drug, to see how safe it is for people with advanced solid tumors who haven't responded to other therapies.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Compugen Ltd (industry)
• Drugs / interventions: prednisone, zimberelimab
• Locations: 11 sites (New Haven, Connecticut and 10 other locations)
• Trial ID: NCT06759649 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and dosing of COM503, both alone and in combination with zimberelimab, in participants with advanced solid tumors. It aims to determine the maximum tolerated dose and the recommended phase 2 dose of COM503. The study is designed for individuals who have experienced disease progression after standard therapies, focusing on the tolerability of this new treatment approach.

Who should consider this trial

Good fit: Ideal candidates are individuals with advanced recurrent or metastatic solid tumor malignancies who have progressed after standard therapies.

Not a fit: Patients with a history of another malignancy within the last two years may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide a new treatment option for patients with advanced solid tumors who have limited alternatives.

How similar studies have performed: Other studies involving monoclonal antibodies and immunotherapy have shown promise, suggesting potential success for this approach.

Eligibility criteria

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.

Where this trial is running

New Haven, Connecticut and 10 other locations

• Yale- New Haven Hospital- Yale Cancer Center — New Haven, Connecticut, United States (RECRUITING)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (RECRUITING)
• START Midwest — Grand Rapids, Michigan, United States (RECRUITING)
• The West Clinic, PLCC dba West Cancer Center — Germantown, Tennessee, United States (RECRUITING)
• NEXT Oncology San Antonio — San Antonio, Texas, United States (RECRUITING)
• START — San Antonio, Texas, United States (RECRUITING)
• NEXT Oncology Virginia — Fairfax, Virginia, United States (RECRUITING)
• Rambam Health Care Campus — Haifa, Israel, Israel (RECRUITING)
• Hadassah University Medical Center- Ein Kerem — Jerusalem, Israel, Israel (RECRUITING)
• Rabin Medical Center — Petah Tikva, Israel, Israel (RECRUITING)
• The Chaim Sheba Medical Center — Ramat Gan, Israel, Israel (RECRUITING)

Study contacts

• Study coordinator: Michelle Chief Medical Officer, MD

Conditions: Neoplasm, Cancer, Malignant Tumors, first-in-human, oncology, monoclonal antibody, immunotherapy