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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Intravenous Infusion
Intravenous infusion
Yale- New Haven Hospital- Yale Cancer Center
New Haven, Connecticut, United States
RECRUITINGBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RECRUITINGSTART Midwest
Grand Rapids, Michigan, United States
RECRUITINGThe West Clinic, PLCC dba West Cancer Center
Germantown, Tennessee, United States
RECRUITINGNEXT Oncology San Antonio
San Antonio, Texas, United States
RECRUITINGSTART- San Antonio
San Antonio, Texas, United States
RECRUITINGNEXT Oncology Virginia
Fairfax, Virginia, United States
RECRUITINGRambam Health Care Campus
Haifa, Israel, Israel
RECRUITINGHadassah University Medical Center- Ein Kerem
Jerusalem, Israel, Israel
RECRUITINGRabin Medical Center
Petah Tikva, Israel, Israel
RECRUITING...and 1 more locations
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.
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