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
Compugen Ltd
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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 i…
Interventions
- DrugCOM503
Intravenous Infusion
- DrugZimberelimab
Intravenous infusion
Locations (11)
- Yale- New Haven Hospital- Yale Cancer CenterNew Haven, Connecticut
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- START MidwestGrand Rapids, Michigan
- The West Clinic, PLCC dba West Cancer CenterGermantown, Tennessee
- NEXT Oncology San AntonioSan Antonio, Texas
- STARTSan Antonio, Texas