This is a Phase 1 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary clinical activity of COM701 as monotherapy and in combination with nivolumab.
This Phase 1 study evaluates the safety, tolerability, Pharmacokinetics (PK) and preliminary clinical activity of COM701 an inhibitor of poliovirus receptor related immunoglobulin domain containing (PVRIG) as monotherapy and in combination with nivolumab in subjects with advanced solid tumors. Cohort expansion will be explored evaluating COM701 monotherapy and in combination with nivolumab in subjects with the following select tumor types (Non-Small cell lung cancer (NSCLC), Ovarian, Breast (including Triple negative breast cancer (TNBC) and endometrial cancer. Other tumor types such as CRC-MSS, CRC-KRAS mutant will be enrolled based on emerging clinical activity data.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
121
COM701 monotherapy.
COM701 in combination with Opdivo (Nivolumab).
University of California Los Angeles (UCLA).
Los Angeles, California, United States
Florida Cancer Specialists
Sarasota, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
START Midwest.
Grand Rapids, Michigan, United States
Columbia University
New York, New York, United States
Cleveland Clinic.
Cleveland, Ohio, United States
The University of Tennessee WEST Cancer Center.
Memphis, Tennessee, United States
Sarah Cannon Research Institute.
Nashville, Tennessee, United States
M D Anderson Cancer Center.
Houston, Texas, United States
...and 1 more locations
Incidence of subjects with Adverse Events (AEs) as per CTCAE v4.03 and Dose-Limiting Toxicities (DLTs).
To evaluate the safety profile of COM701 monotherapy and in combination with nivolumab.
Time frame: DLT evaluation window in the 1st cycle (21 or 28 days).
Determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RDFE) (COM701 monotherapy and in combination with nivolumab).
Time frame: Approximately 2 year.
Incidence of subjects with Anti-COM701 antibody.
Immunogenicity of COM701 monotherapy and in combination with nivolumab.
Time frame: Approximately 2 years.
Overall Response Rate as per RECIST v1.1
Preliminary antitumor activity of COM701 in combination with nivolumab.
Time frame: Approximately 2 years.
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