COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies

Phase 1

Active, not recruiting

• Conditions: HNSCC; MSS-CRC; Advanced Cancer; Lung Cancer; Ovarian Cancer; Colon Cancer; Multiple Myeloma; Microsatellite Stable Colorectal Carcinoma; Plasma Cell Neoplasm

• Registration Number: NCT04354246
• Lead Sponsor: Compugen Ltd

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 in subjects with advanced malignancies.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-31
• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-21
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-18
• Last Update Posted: 2025-05-22
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
The safety and tolerability of COM902 monotherapy and in combination with COM701.	DLT evaluation window in the 1st cycle (21 Days).	Incidence of subjects with Adverse Events (AEs) as per CTCAE v5.0 and Dose-Limiting Toxicities (DLTs).
To identify the maximum tolerated dose (MTD) and/or recommended dose for expansion of COM902 monotherapy and in combination with COM701.	18 months.	Evaluation of a dose of COM902 monotherapy and in combination with COM701 that is well tolerated by subjects.
Evaluation of safety and tolerability of the Triplet combination (COM902 + COM701 + Pembrolizumab).	18 months.	Incidence of subjects on the Triplet combination (COM902 + COM701 + Pembrolizumab) with Adverse Events (AEs) per CTCAE v5.0.
Evaluation of the PK profile of the Triplet combination (COM902 + COM701 + Pembrolizumab).	18 months.	Evaluation of PK parameters e.g., AUC.
To characterize the pharmacokinetic (PK) profile of COM902 as monotherapy and in combination with COM701.	18 months.	Evaluation of parameters of COM902 monotherapy or in combination with COM701 exposure such as Maximum Plasma Concentration \[Cmax\]).

Secondary Outcome Measures

Name	Time	Method
To characterize immunogenicity of COM902 monotherapy and in combination with COM701.	18 months.	Evaluation of anti drug antibody to COM902 (monotherapy) or COM902, COM701 when administered in combination.
To characterize the immunogenicity of the Triplet combination (COM902 + COM701 + Pembrolizumab).	18 months.	Evaluation of antidrug antibody to COM902, COM701.

Trial Locations

Locations (9)

Florida Cancer Specialists; 🇺🇸 Sarasota, Florida, United States

Massachusetts General Hospital.; 🇺🇸 Boston, Massachusetts, United States

START Midwest.; 🇺🇸 Grand Rapids, Michigan, United States

The Ohio State University Comprehensive Cancer Center.; 🇺🇸 Columbus, Ohio, United States

The University of Tennessee WEST Cancer Center.; 🇺🇸 Memphis, Tennessee, United States

Mary Crowley Cancer Research; 🇺🇸 Dallas, Texas, United States

MD Anderson Cancer Center.; 🇺🇸 Houston, Texas, United States

The START Center for Cancer Care.; 🇺🇸 San Antonio, Texas, United States

Froedtert & Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States