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

Launched by COMPUGEN LTD · Dec 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called COM503 for patients with advanced solid tumors, which are types of cancer that have spread and are difficult to treat. The main goal is to understand how safe COM503 is when given alone or together with another medication called zimberelimab. Researchers want to find out the highest dose of COM503 that patients can safely take and if it works effectively for those with advanced cancer who have not had success with other treatments.

To participate in this trial, patients must have a confirmed diagnosis of an advanced solid tumor and have experienced disease progression after standard treatments. Eligible participants will undergo tests to measure their tumors and will receive close monitoring throughout the trial. This study is currently recruiting individuals aged 65 and older, and it's open to all genders. It's important to note that people with certain health conditions or a history of other cancers may not be eligible. Participants will have the opportunity to contribute to important research that may help improve treatments for future cancer patients.

Gender

ALL

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.