A Phase 1/2 interventional study of COM701 in combination with BMS-986207 and nivolumab. in Endometrial Neoplasms, Ovarian Cancer and Solid Tumor, sponsored by Compugen Ltd. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-18.
Sponsored by Compugen Ltd · Phase 1/2, Interventional, and Treatment
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.
Key Inclusion Criteria:
During cohort expansion: All subjects must have measurable disease as defined by RECIST v1.1.
Expansion Cohorts:
Key Exclusion Criteria:
Key Exclusion Criteria For Dose Expansion Cohorts:
Up to 5 sequential dose escalation cohorts of COM701 in combination with fixed doses of BMS-986207 and nivolumab. All study drugs will be administered IV every 4 weeks until a maximum tolerated dose or recommended dose for expansion is identified.
Drug: COM701 in combination with BMS-986207 and nivolumab.
Single arm: subjects with platinum resistant/refractory epithelial ovarian cancer, primary peritoneal or fallopian tube cancer will be randomized to receive study treatment with COM701 in combination with BMS-986207 and nivolumab. The study drugs will be administered IV every 4 weeks.
Drug: COM701 in combination with BMS-986207 and nivolumab.
Single arm: subjects with MSS-endometrial cancer will receive study treatment with COM701 in combination with BMS-986207 and nivolumab. All study drugs will be administered IV every 4 weeks.
Drug: COM701 in combination with BMS-986207 and nivolumab.
Single arm: subjects with tumor types with high expression of PVRL2 will receive study treatment with COM701 in combination with BMS-986207 and nivolumab. All study drugs will be administered IV every 4 weeks.
Drug: COM701 in combination with BMS-986207 and nivolumab.
Two arms: subjects with head and neck cancer. Equal number of subjects in each of the 2 arms. One arm will enroll subjects who have not previously received treatment with an immune checkpoint inhibitor, the other arm will enroll subjects who have received prior treatment with an immune checkpoint inhibitor. All subjects will receive study treatment with COM701 in combination with BMS-986207 and nivolumab. All study drugs will be administered IV every 4 weeks.
Drug: COM701 in combination with BMS-986207 and nivolumab.
Study treatment with the 3 drug combination (COM701 in combination with BMS-986207 and nivolumab).
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.
Plan to share: No
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Compugen Ltd