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
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.
Arms & interventions
- DrugCOM503
Intravenous Infusion
- DrugZimberelimab
Intravenous infusion
Outcome measures
Primary
To evaluate the safety profile of COM503 as monotherapy in participants with advanced malignancies.
Number of participants in monotherapy cohorts with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 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.
To evaluate the safety profile of COM503 as monotherapy in participants with advanced malignancies.
Number of participants in monotherapy cohorts with treatment-related serious adverse events as assessed by CTCAE v4.0
Time frame: 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.
To evaluate the safety profile of COM503 in combination with zimberelimab in participants with advanced malignancies
Number of participants in combination cohorts with treatment-related adverse events as assessed by CTCAE v4.
Time frame: 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.
To evaluate the safety profile of COM503 in combination with zimberelimab in participants with advanced malignancies
Number of participants in combination cohorts with treatment-related serious adverse events as assessed by CTCAE v4.
Time frame: 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.
Eligibility criteria
Study locations (7)
Yale- New Haven Hospital- Yale Cancer Center
New Haven, Connecticut, 06510
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 0221502215
START Midwest
Grand Rapids, Michigan, 49546
The West Clinic, PLCC dba West Cancer Center
Germantown, Tennessee, 38138
NEXT Oncology San Antonio
San Antonio, Texas, 78229
START
San Antonio, Texas, 78229
NEXT Oncology Virginia
Fairfax, Virginia, 22031