Ovarian Cancer Clinical Trial
COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies
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 in subjects with advanced malignancies.
Key Inclusion Criteria:
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 Criteria:
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.
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