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Dose escalation: COM902 monotherapy

Phase 1

Advanced Cancer | Small molecule | Oncology |Compugen Ltd.|Last Updated: Aug 12, 2026

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment94

FDA Designations

No designations recorded

Clinical trial landscape

Dose escalation: COM902 monotherapy · 1 trial · 9 indications

Phase 1 1
NCT04354246COM902 (A TIGIT Inhibitor) in Subjects With Advanced MalignanciesAdvanced Cancer
COMPLETED94 Analytics
PHASE1COMPLETED
COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies
Advanced CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

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.

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 \[Cmax\]).

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., Cmax.

Secondary Endpoints

To characterize immunogenicity of COM902 monotherapy and in combination with COM701.
18 months.
To characterize the immunogenicity of the Triplet combination (COM902 + COM701 + Pembrolizumab).
18 months.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
COM902 monotherapy dose escalation.EXPERIMENTALMonotherapy 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.
Dual combination (COM902 + COM701) for evaluation of safety/tolerability (both at RDFE).EXPERIMENTALCOM902 will be combined with COM701 for evaluation of safety and tolerability. All study drugs will be administered IV every 3 weeks.
COM902 monotherapy cohort expansion at RDFE.EXPERIMENTALCOM902 monotherapy at the RDFE - in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks.
COM902 + COM701 combination cohort expansion both at RDFE.EXPERIMENTALCOM902 + 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.
MSS-CRC Triplet combination (COM902 + COM701 + Pembrolizumab).EXPERIMENTALTriplet combination of COM902 + COM701 + Pembrolizumab evaluated in subjects with MSS-CRC. All study drugs will be administered IV every 3 weeks.
Platinum resistant ovarian cancer Triplet combination (COM902 + COM701 + Pembrolizumab).EXPERIMENTALTriplet combination of COM902 + COM701 + Pembrolizumab evaluated in subjects with PROC. All study drugs will be administered IV every 3 weeks.

Interventions

NameTypeDescription
Dose escalation: COM902 monotherapy.DRUGCOM902 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_PRODUCTBoth 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.DRUGCOM902 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).DRUGCOM902 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_PRODUCTTriplet combination of COM902 + COM701 + Pembrolizumab administered IV every 3 weeks.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

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 rel...

Countries:United States
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Competitive Landscape -Cancer 5 trials (matched to "Advanced Cancer")

Frequently asked questions about Dose escalation: COM902 monotherapy

What is COM902 used for?

COM902 is an investigational small molecule being studied for the treatment of advanced cancer, including ovarian cancer, lung cancer, colon cancer, multiple myeloma, head and neck squamous cell carcinoma, and microsatellite stable colorectal carcinoma. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does COM902 target?

COM902 is a TIGIT inhibitor, meaning it targets the TIGIT receptor, an immune checkpoint protein. By inhibiting TIGIT, COM902 is designed to enhance the body's immune response against cancer cells. This mechanism is being evaluated in a Phase 1 clinical trial for patients with advanced malignancies.

Who is developing COM902?

COM902 is being developed by Compugen Ltd., a biopharmaceutical company traded on the Nasdaq under the ticker symbol CGEN. The company is conducting clinical research to evaluate the safety and efficacy of COM902 in patients with advanced cancer.

What phase is COM902 in?

COM902 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational, meaning it has not received FDA approval and is still being studied for safety and dosing in patients with advanced malignancies.

What clinical trials is COM902 in?

COM902 has been studied in one clinical trial, registered as NCT04354246, titled "COM902 (A TIGIT Inhibitor) in Subjects With Advanced Malignancies." This Phase 1 trial enrolled 94 participants with advanced cancer and was conducted in the United States. The trial has been completed.

Is COM902 the same as any other drug?

COM902 is a distinct investigational drug developed by Compugen Ltd. No alternative names for COM902 have been reported in the clinical trial data. It is being studied as a monotherapy in a dose escalation trial for advanced cancer.