Status:
ACTIVE_NOT_RECRUITING
COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies
Lead Sponsor:
Compugen Ltd
Conditions:
Advanced Cancer
Ovarian Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Phase 1 open label sequential dose escalation and cohort expansion study evaluating the safety, tolerability and preliminary antitumor activity of COM902 as monotherapy and in combination with COM701 ...
Eligibility Criteria
Inclusion
- Key
- Subjects with histologically/cytologically confirmed advanced malignancy (solid tumor) who must have exhausted all available standard therapy, or not a candidate for standard therapy.
- Subject is able to provide written, informed consent before initiation of any study related procedures, and is able, in the opinion of the investigator, to comply with all the requirements of the study.
- Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- For Triplet combination MSS-CRC:
- Histologically confirmed adenocarcinoma of the colon/rectum
- Stage IV disease
- MSS-CRC status by an FDA approved test
- Disease progression with no more than 3 prior lines of treatment including fluroropyrimidines, irinotecan, and oxaliplatin
- For Triplet combination ovarian cancer:
- Advanced epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
- Platinum resistant ovarian cancer (PROC) defined as disease recurrence \< 6 months after completion of a platinum-containing regimen: Patients with primary platinum refractory disease are ineligible. Primary platinum refractory disease is defined as progression of disease prior to completion of 1st line platinum therapy or immediately following (≤ 3 months following last date of chemotherapy)
- Received ≤3 prior lines for PROC; maintenance bevacizumab or PARP are not included as a line of therapy
- Subjects who have received PARP inhibitor therapy are eligible
- Key
Exclusion
- Prior treatment with a TIGIT inhibitor.
- Prior treatment with an inhibitor of PVRIG
- Symptomatic interstitial lung disease or inflammatory pneumonitis.
- History of immune-related events that required immunotherapy treatment discontinuation
- For Triplet combination expansion cohorts (MSS-CRC and PROC): Prior treatment with an anti-PD-1/PD-L1/2, anti-CD96 antibody, anti-OX-40 antibody, anti-CD137 antibody, anti-LAG3, anti-TIM3, anti-CTLA4 antibody.
Key Trial Info
Start Date :
March 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04354246
Start Date
March 31 2020
End Date
December 30 2025
Last Update
May 22 2025
Active Locations (9)
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1
Florida Cancer Specialists
Sarasota, Florida, United States, 34230
2
Massachusetts General Hospital.
Boston, Massachusetts, United States, 02114
3
START Midwest.
Grand Rapids, Michigan, United States, 49503
4
The Ohio State University Comprehensive Cancer Center.
Columbus, Ohio, United States, 43210