COM701 in Combination With BMS-986207 and Nivolumab in Subjects With Advanced Solid Tumors.
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Key Inclusion Criteria:
- Histologically or cytologically confirmed, locally advanced or metastatic solid malignancy and has exhausted all available standard therapy or is not a candidate for the available standard therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- During dose escalation - Subjects who received prior therapy with anti-PD-1, anti-PD-L1, anti- CTLA-4, OX-40, CD137, etc., are eligible.
During cohort expansion: All subjects must have measurable disease as defined by RECIST v1.1.
Expansion Cohorts:
- Cohort 1 (subjects with advanced epithelial ovarian, fallopian tube, or primary peritoneal carcinoma)
- Subject must have platinum refractory/resistant ovarian cancer defined as refractoriness to platinum-containing regimen or disease recurrence < 6 months after completion of a platinum-containing regimen
- Cohort 2 (endometrial cancer cohort)
- Subjects with locally advanced or metastatic microsatellite stable endometrial cancer with disease recurrence or progression during or after prior therapy that included platinum-based chemotherapy.
- Subjects must have documented MSS status by an approved test e.g. genomic testing, IHC for mismatch repair proficient.
- Subjects must have received no more than 2 prior systemic cytotoxic therapies; there are no limits to the number of prior endocrine or antiangiogenic regimens
- Cohort 3 (basket cohort, excludes tumor types in cohorts 1 and 2)
- Tumor types with high expression of PVRL2 (determined by central testing).
- Cohort 4 (Head and Neck cancer)
- Histologically confirmed recurrent or metastatic HNSCC (oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, paranasal sinus, nasopharyngeal)
- Cohort 4a - IO naïve. Eligible subjects can be systemic therapy naïve (frontline) or platinum failure.
- Cohort 4b - IO failure. No limitations on the number of prior lines of systemic therapy.
EXCLUSION CRITERIA
Key Exclusion Criteria:
- Active autoimmune disease requiring systemic therapy in the last 2 years prior to the first dose of COM701.
- Symptomatic interstitial lung disease or inflammatory pneumonitis.
- History of immune-related events that lead to immunotherapy treatment discontinuation.
- Untreated or symptomatic central nervous system (CNS) metastases.
Key Exclusion Criteria For Dose Expansion Cohorts:
- Cohort 1: Prior therapy with an anti-PD-1/PD-L1/2, COM701 (or any inhibitor of PVRIG), anti-TIGIT antibody, anti-CTLA-4 antibody, anti-OX-40 antibody, anti-CD137 antibody.
- Cohort 2: Prior therapy with COM701 (or any inhibitor of PVRIG) or anti-TIGIT antibody. Subjects with MSI-H endometrial cancer are ineligible.
- Cohort 3: Prior therapy with COM701 (or any inhibitor of PVRIG) or anti-TIGIT antibody are ineligible.
- Cohort 4: Subjects who have received prior therapy with COM701 (or any inhibitor of PVRIG), anti-TIGIT antibody, anti-CTLA-4 antibody, anti-OX-40 antibody, anti-CD137 antibody. Subjects in cohort 4a must be IO-naïve.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Endometrial Neoplasms,Ovarian Cancer,Solid Tumor,Head and Neck Cancer
Age (in years)
18+
Phase
Phase 1/Phase 2
Participants needed
100
Est. Completion Date
Dec 31, 2023
Treatment type
Interventional
Sponsor
Compugen Ltd
ClinicalTrials.gov identifier
NCT04570839
Study number
CPG-03-101
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