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COM701

Phase 1

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

Success Probability
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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")
Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06888921primaryCompletionDate: changed
LOWMay 24, 2026NCT06888921studyFirstPostDate: changed