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COM701

Phase 1

Advanced Cancer | Small molecule | Oncology |Compugen Ltd.|Last Updated: Apr 1, 2026

Target and mechanism

Molecular targetPVRIG
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment121

FDA Designations

No designations recorded

Clinical trial landscape

COM701 · 2 trials · 11 indications

Phase 1 2
NCT06888921A Clinical Trial to Evaluate the Safety and Efficacy of COM701 in Relapsed Platinum Sensitive Ovarian CancerOvarian Cancer
RECRUITING60 Analytics
NCT03667716COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.Advanced Cancer
COMPLETED121 Analytics
PHASE1RECRUITING
A Clinical Trial to Evaluate the Safety and Efficacy of COM701 in Relapsed Platinum Sensitive Ovarian Cancer
Ovarian CancerUnlock trial analytics
PHASE1COMPLETED
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
Advanced CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the effect of COM701 as a single agent on progression free survival when administered as a maintenance regimen in participants with relapsed PSOC
From the date of randomization until the date of disease progression, or date of death from any cause whichever occurs first, assessed up to 2 years

Progression free survival in COM701-treated participants compared to placebo-treated participants

Incidence of subjects with Adverse Events (AEs) as per CTCAE v4.03 and Dose-Limiting Toxicities (DLTs).
DLT evaluation window in the 1st cycle (21 or 28 days).

To evaluate the safety profile of COM701 monotherapy and in combination with nivolumab.

Determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RDFE) (COM701 monotherapy and in combination with nivolumab).
Approximately 2 year.

Secondary Endpoints

To evaluate the safety and tolerability of the COM701 as a single agent when administered as a maintenance regimen in participants with relapsed PSOC
From randomization up to 90 days post last cycle of study treatment (each cycle is 3 weeks; study treatment may continue up to 2 years).
To evaluate the effect of COM701 as a single agent on other efficacy endpoints when administered as a maintenance regimen in participants with relapsed PSOC
From date of randomization until the date of the initiation of a new anti-cancer treatment, or date of death from any cause whichever occurs first, assessed up to 2 years.
Incidence of subjects with Anti-COM701 antibody.
Approximately 2 years.
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
COM701EXPERIMENTAL -
Normal SalinePLACEBO_COMPARATOR -
P1a Arm A (Monotherapy Dose Escalation).EXPERIMENTALCOM701 monotherapy sequential dose escalation administered IV every 3 weeks and a Cohort IV every 4 weeks. Up to 8 dose escalation cohorts may be evaluated until a maximum tolerated dose or recommended phase 2 dose is identified.
P1a Arm B (Combination Dose Escalation).EXPERIMENTALCOM701 sequential dose escalation administered IV every 3 weeks in combination with Opdivo (Nivolumab) 360mg administered IV every 3 weeks and COM701 administered IV every 4 weeks in combination with Opdivo (Nivolumab) 480mg administered IV every 4 weeks.
P1a Arm A (Monotherapy Expansion).EXPERIMENTALCOM701 monotherapy administered IV every 4 weeks. Cohort expansion in subjects with the following select tumor types (NSCLC, Breast, Ovarian, Endometrial and Colorectal cancer).
P1b (Combination Cohort Dose Expansion).EXPERIMENTALCOM701 administered IV every 4 weeks in combination with Opdivo (Nivolumab) 480 mg administered IV every 4 weeks. Cohort expansion in subjects with the following select tumor types (Breast, Ovarian, Endometrial and Colorectal cancer).

Interventions

NameTypeDescription
COM701DRUGCOM701 will be administered via intravenous (IV) infusion once every 3 weeks.
Normal SalineDRUGSaline will be administered via intravenous (IV) infusion once every 3 weeks
COM701 with Opdivo (Nivolumab).DRUGCOM701 in combination with Opdivo (Nivolumab).
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: * Has relapsed platinum sensitive epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer * Has completed at least 2 previous courses (i.e. lines) of platinum-containing therapy * For the last chemotherapy course prior to being randomized into the study, mu...

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

Frequently asked questions about COM701

What is COM701 used for?

COM701 is an investigational small molecule being developed for the treatment of advanced solid tumors, including ovarian cancer. It is being studied in patients with advanced cancer, ovarian cancer, breast cancer, lung cancer, endometrial cancer, and colorectal cancer. The drug is currently in Phase 1 clinical development and is not yet approved by the FDA.

What does COM701 target?

COM701 targets PVRIG, a protein involved in immune regulation. By inhibiting PVRIG, COM701 is designed to modulate the immune system's response to cancer cells. This mechanism is being evaluated in clinical trials for its potential to treat advanced solid tumors, including ovarian cancer.

Who makes COM701?

COM701 is being developed by Compugen Ltd., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CGEN. The company is conducting clinical trials to evaluate the safety and efficacy of COM701 in patients with advanced solid tumors and ovarian cancer.

What phase is COM701 in?

COM701 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in early-stage trials to assess its safety, tolerability, and preliminary efficacy in patients with advanced solid tumors and ovarian cancer.

What clinical trials is COM701 in?

COM701 is being evaluated in two Phase 1 clinical trials. The first, NCT03667716, is a completed study in patients with advanced solid tumors, enrolling 121 participants in the United States. The second, NCT06888921, is currently recruiting patients with relapsed platinum-sensitive ovarian cancer, with a target enrollment of 60 participants across the United States, France, and Israel.

Is COM701 the same as any other drug?

COM701 is a unique investigational drug developed by Compugen Ltd. It is not known to be the same as any other approved or marketed medication. Its distinct mechanism of targeting PVRIG sets it apart from other cancer therapies currently in development.