Title
Compugen CPG-05-101 Phase 1 Advanced Solid Tumors COM503
Study 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
Malignancy
Advanced Solid Tumors: Breast, Lung, Colon, Prostate, Pancreatic, Gastric, Esophageal, HCC, Ovarian, Endometrial, Cervical, HNSCC, Head and Neck, Bladder, Sarcoma
Drug Class
Anti-IL18 blocking protein antibody
Key Eligibility Criteria Details
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.
- Measurable Disease
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.
