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COM701

Phase 1

Advanced Cancer | Small molecule | Oncology |Compugen Ltd.|Last Updated: Jan 17, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment121
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03667716COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.PHASE1 COMPLETED 121Sep 6, 2018Jan 30, 2024Jan 17, 202511 United States
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Study Endpoints
Primary Endpoints
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
Incidence of subjects with Anti-COM701 antibody.
Approximately 2 years.
Overall Response Rate as per RECIST v1.1
Approximately 2 years.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
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 monotherapy.
COM701 with Opdivo (Nivolumab).DRUGCOM701 in combination with Opdivo (Nivolumab).
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites11

Key Inclusion Criteria: * Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Subjects who received prior immune-stimulatory antitumor agents, such as anti-PD-1, anti-PD-L1, anti-CTLA-4, OX-40, CD137, etc. are eligible. * Histologically or cytologically confirmed, locall...

Countries:United States
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