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COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies

CompletedPhase 1

Sponsor: Compugen Ltd

Conditions: Advanced Cancer, Ovarian Cancer, Lung Cancer, Colon Cancer, Plasma Cell Neoplasm

Interventions: Dose escalation: COM902 monotherapy., Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE), Cohort expansion: COM902 (RDFE) monotherapy., Cohort expansion: COM902 in combination with COM701 (both at the RDFE)., Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab.

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (9)

Sarasota, Florida, United States
Boston, Massachusetts, United States
Grand Rapids, Michigan, United States
Columbus, Ohio, United States
Memphis, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Milwaukee, Wisconsin, United States