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Dose escalation: COM902 monotherapy.

Phase 1

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

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 Enrollment94
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04354246COM902 (A TIGIT Inhibitor) in Subjects With Advanced MalignanciesPHASE1 COMPLETED 94Mar 31, 2020Apr 1, 2026May 12, 20269 United States
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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 — 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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Recent Changes (Last 90 Days)
HIGHMay 26, 2026NCT04354246Status: ACTIVE_NOT_RECRUITING → COMPLETED
LOWMay 24, 2026NCT04354246studyFirstPostDate: changed