COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies

NCT ID: NCT04354246

Last Updated: 2025-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-31

Study Completion Date

2025-12-30

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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COM902 monotherapy dose escalation.

Monotherapy dose escalation. COM902 monotherapy administered IV every 3 weeks in sequential dose escalation. Up to 7 dose escalation cohorts may be evaluated until a maximum tolerated dose or recommended dose for expansion (RDFE) is identified.

Group Type EXPERIMENTAL

Dose escalation: COM902 monotherapy.

Intervention Type DRUG

COM902 monotherapy administered IV every 3 weeks in sequential dose escalation doses in cohorts of subjects.

Dual combination (COM902 + COM701) for evaluation of safety/tolerability (both at RDFE).

COM902 will be combined with COM701 for evaluation of safety and tolerability. All study drugs will be administered IV every 3 weeks.

Group Type EXPERIMENTAL

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

Intervention Type COMBINATION_PRODUCT

Both study drugs will be evaluated at the RDFE for assessment of safety and tolerability. All study drugs will be administered IV every 3 weeks.

COM902 monotherapy cohort expansion at RDFE.

COM902 monotherapy at the RDFE - in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks.

Group Type EXPERIMENTAL

Cohort expansion: COM902 (RDFE) monotherapy.

Intervention Type DRUG

COM902 monotherapy (RDFE) in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks.

COM902 + COM701 combination cohort expansion both at RDFE.

COM902 + COM701 (both at the RDFE) evaluated in subjects with select tumor types who have exhausted standard of care treatment: HNSCC, CRC (MSS), NSCLC. All study drugs will be administered IV every 3 weeks.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

COM902 in combination with COM701 (both at RDFE) in subjects with select tumor types who have exhausted standard treatment - HNSCC, CRC (MSS), NSCLC. All study drugs will be administered IV every 3 weeks.

MSS-CRC Triplet combination (COM902 + COM701 + Pembrolizumab).

Triplet combination of COM902 + COM701 + Pembrolizumab evaluated in subjects with MSS-CRC. All study drugs will be administered IV every 3 weeks.

Group Type EXPERIMENTAL

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

Intervention Type COMBINATION_PRODUCT

Triplet combination of COM902 + COM701 + Pembrolizumab administered IV every 3 weeks.

Platinum resistant ovarian cancer Triplet combination (COM902 + COM701 + Pembrolizumab).

Triplet combination of COM902 + COM701 + Pembrolizumab evaluated in subjects with PROC. All study drugs will be administered IV every 3 weeks.

Group Type EXPERIMENTAL

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

Intervention Type COMBINATION_PRODUCT

Triplet combination of COM902 + COM701 + Pembrolizumab administered IV every 3 weeks.

Interventions

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Dose escalation: COM902 monotherapy.

COM902 monotherapy administered IV every 3 weeks in sequential dose escalation doses in cohorts of subjects.

Intervention Type DRUG

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

Both study drugs will be evaluated at the RDFE for assessment of safety and tolerability. All study drugs will be administered IV every 3 weeks.

Intervention Type COMBINATION_PRODUCT

Cohort expansion: COM902 (RDFE) monotherapy.

COM902 monotherapy (RDFE) in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks.

Intervention Type DRUG

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

COM902 in combination with COM701 (both at RDFE) in subjects with select tumor types who have exhausted standard treatment - HNSCC, CRC (MSS), NSCLC. All study drugs will be administered IV every 3 weeks.

Intervention Type DRUG

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

Triplet combination of COM902 + COM701 + Pembrolizumab administered IV every 3 weeks.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Compugen Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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COM902 Study Director COM902 Study Director

Role: STUDY_DIRECTOR

Compugen Ltd

Locations

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Florida Cancer Specialists

Sarasota, Florida, United States

Site Status

Massachusetts General Hospital.

Boston, Massachusetts, United States

Site Status

START Midwest.

Grand Rapids, Michigan, United States

Site Status

The Ohio State University Comprehensive Cancer Center.

Columbus, Ohio, United States

Site Status

The University of Tennessee WEST Cancer Center.

Memphis, Tennessee, United States

Site Status

Mary Crowley Cancer Research

Dallas, Texas, United States

Site Status

MD Anderson Cancer Center.

Houston, Texas, United States

Site Status

The START Center for Cancer Care.

San Antonio, Texas, United States

Site Status

Froedtert & Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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CPG-02-101

Identifier Type: -

Identifier Source: org_study_id

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