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A Phase 1 Study of The Safety and Tolerability of COM902 in Subjects With Advanced Malignancies


Description

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.

Trial Eligibility

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.

Study Info

Organization

Compugen Ltd


Primary Outcome

The safety and tolerability of COM902 monotherapy and in combination with COM701.


Outcome Timeframe DLT evaluation window in the 1st cycle (21 Days).

NCTID NCT04354246

Phases PHASE1

Primary Purpose TREATMENT

Start Date 2020-03-31

Completion Date 2024-12-30

Enrollment Target 110

Interventions

DRUG Dose escalation: COM902 monotherapy.

COMBINATION_PRODUCT Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE)

DRUG Cohort expansion: COM902 (RDFE) monotherapy.

DRUG Cohort expansion: COM902 in combination with COM701 (both at the RDFE).

COMBINATION_PRODUCT Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab.

Locations Recruiting

Florida Cancer Specialists

United States, Florida, Sarasota


Massachusetts General Hospital.

United States, Massachusetts, Boston


START Midwest.

United States, Michigan, Grand Rapids


The Ohio State University Comprehensive Cancer Center.

United States, Ohio, Columbus


The University of Tennessee WEST Cancer Center.

United States, Tennessee, Memphis


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