This is a phase 1/2 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary antitumor activity of COM701 in combination with BMS-986207 and nivolumab in patients with advanced solid tumors.
This phase 1/2 study evaluates the safety/tolerability, pharmacokinetics and preliminary antitumor activity of COM701 an inhibitor of poliovirus receptor related immunoglobulin domain containing (PVRIG) in combination with BMS-986207 (an inhibitor of TIGIT) and nivolumab in subjects with advanced solid tumors. The study will consist of 2 parts (part 1 - dose escalation and part 2 - dose expansion). Part 1: escalating doses of COM701 will be combined with fixed doses of BMS-986207 and nivolumab. Upon completion of dose escalation a recommended dose of COM701 in combination with BMS-986207 and nivolumab (3-drug combination) will be determined. Part 2: subjects will be administered the recommended dose of COM701 in combination with BMS-986207 and nivolumab. Subjects will be enrolled into one of three cohorts based on their cancer type. Cohort 1: subjects with platinum resistant/refractory ovarian cancer, primary peritoneal or fallopian tube cancer will receive study treatment with the 3-drug combination. Cohort 2: subjects with MSS- endometrial cancer will receive study treatment with the 3-drug combination. Cohort 3 (Basket cohort): subjects with tumors that have high expression of a biomarker (PVRL2) will receive study treatment with the 3-drug combination. Subjects with tumor types in cohorts 1, 2 and 4 will not be enrolled into this cohort. Cohort 4: subjects with HNSCC. This cohort will enroll subjects who have received treatment with an immune checkpoint inhibitor or subjects who have received treatment with chemotherapy but not an immune checkpoint inhibitor. All subjects enrolled in this cohort will receive study treatment with the 3-drug combination.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Study treatment with the 3 drug combination (COM701 in combination with BMS-986207 and nivolumab).
University of Chicago Medical Center
Chicago, Illinois, United States
Johns Hopkins University Oncology Center.
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
The proportion of subjects with adverse events on the study.
The proportion of subjects with any adverse event (AE) per CTCAE v5.0.
Time frame: 2 years.
The proportion of subjects with adverse events in the 1st cycle during dose escalation within the DLT window (28 days).
The proportion of subjects with adverse events meeting the criteria of dose-limiting toxicities (DLTs) in the 1st 28 days of the 1st cycle of study treatment during dose escalation.
Time frame: Within the DLT window (1st 28 days) of the 1st cycle during dose escalation.
The recommended dose for expansion (RDFE) of the combination.
The dose of COM701 in combination with BMS-986207 and nivolumab for the expansion cohort.
Time frame: 2 years.
The Area under the curve of COM701 in subjects receiving the 3-drug combination.
The PK profile of COM701 in combination with BMS-986207 and nivolumab.
Time frame: 2 years.
The objective response rate of subjects enrolled in cohorts 1-4.
Objective response rate per RECIST v1.1.
Time frame: 3 years.
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START Midwest.
Grand Rapids, Michigan, United States
Columbia University
New York, New York, United States
University of Pittsburgh Cancer Center.
Pittsburgh, Pennsylvania, United States
The University of Tennessee WEST Cancer Center.
Memphis, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
The START Center for Cancer Care.
San Antonio, Texas, United States