Advanced CancerPhase 1NCT04354246

COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies

A Phase 1 study testing Dose escalation: COM902 monotherapy., Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE) and Cohort expansion: COM902 (RDFE) monotherapy. in people with Advanced Cancer and Ovarian Cancer, run by Compugen Ltd at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Cancer, Ovarian Cancer, Lung Cancer
What is being tested?: Dose escalation: COM902 monotherapy., Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE) and Cohort expansion: COM902 (RDFE) monotherapy.
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 94 participants
Where: 9 sitesUnited States
Study dates: 31 Mar 2020to 1 Apr 2026
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Massachusetts General Hospital.
Boston, Massachusetts, 02114
The Ohio State University Comprehensive Cancer Center.
Columbus, Ohio, 43210
Mary Crowley Cancer Research
Dallas, Texas, 75230
START Midwest.
Grand Rapids, Michigan, 49503
MD Anderson Cancer Center.
Houston, Texas, 77030
The University of Tennessee WEST Cancer Center.
Memphis, Tennessee, 38138
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
The START Center for Cancer Care.
San Antonio, Texas, 78229
Florida Cancer Specialists
Sarasota, Florida, 34230

Other trials in United States

About this study

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

Conditions: Advanced Cancer, Ovarian Cancer, Lung Cancer, Colon Cancer, Plasma Cell Neoplasm, Multiple Myeloma
Being tested: 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.
Keywords: TIGIT antibody, PVRIG antibody, COM701, Low Fc-effector function, Pembrolizumab
Medical subject headings: Ovarian Neoplasms, Lung Neoplasms, Colonic Neoplasms, Neoplasms, Plasma Cell, Multiple Myeloma, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dose escalation: COM902 monotherapy.Drug
COM902 monotherapy administered IV every 3 weeks in sequential dose escalation doses in cohorts of subjects.
Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE)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.
Cohort expansion: COM902 (RDFE) monotherapy.Drug
COM902 monotherapy (RDFE) in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks.
Cohort expansion: COM902 in combination with COM701 (both at the RDFE).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.
Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab.Combination product
Triplet combination of COM902 + COM701 + Pembrolizumab administered IV every 3 weeks.

Study groups in NCT04354246
Study group	Role	What they receive
COM902 monotherapy dose escalation.	Experimental	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. Receives: Drug: Dose escalation: COM902 monotherapy.
Dual combination (COM902 + COM701) for evaluation of safety/tolerability (both at RDFE).	Experimental	COM902 will be combined with COM701 for evaluation of safety and tolerability. All study drugs will be administered IV every 3 weeks. Receives: Combination Product: Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE)
COM902 monotherapy cohort expansion at RDFE.	Experimental	COM902 monotherapy at the RDFE - in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks. Receives: Drug: Cohort expansion: COM902 (RDFE) monotherapy.
COM902 + COM701 combination cohort expansion both at RDFE.	Experimental	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. Receives: Drug: Cohort expansion: COM902 in combination with COM701 (both at the RDFE).
MSS-CRC Triplet combination (COM902 + COM701 + Pembrolizumab).	Experimental	Triplet combination of COM902 + COM701 + Pembrolizumab evaluated in subjects with MSS-CRC. All study drugs will be administered IV every 3 weeks. Receives: Combination Product: Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab.
Platinum resistant ovarian cancer Triplet combination (COM902 + COM701 + Pembrolizumab).	Experimental	Triplet combination of COM902 + COM701 + Pembrolizumab evaluated in subjects with PROC. All study drugs will be administered IV every 3 weeks. Receives: Combination Product: Cohort expansion: Triplet combination of COM902 + COM701 + Pembrolizumab.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Mar 20201 Apr 2026

First posted21 Apr 2020
Study start31 Mar 2020
Primary completion1 Apr 2026
Study completion1 Apr 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04354246
Sponsor's protocol ID: CPG-02-101
Status last verified: May 2026
First submitted: 15 Apr 2020
Last updated: 12 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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