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COM503

Phase 1

Neoplasm | Small molecule | Oncology |Compugen Ltd.|Last Updated: Feb 27, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06759649A Clinical Trial to Assess COM503 in Participants With Advanced Solid MalignanciesPHASE1 RECRUITING 200Jan 7, 2025Nov 22, 2027Feb 27, 202611 United States, Israel
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Study Endpoints
Primary Endpoints
To evaluate the safety profile of COM503 as monotherapy in participants with advanced malignancies.
from the first dose of COM503 to the earlier of 90 days following the last dose of COM503 and/or zimberelimab or start of a new anticancer therapy.

Number of participants in monotherapy cohorts with treatment-related adverse events as assessed by CTCAE v4.0

To evaluate the safety profile of COM503 in combination with zimberelimab in participants with advanced malignancies
from the first dose of COM503 in combination with zimberelimab to the earlier of 90 days following the last dose of COM503 and/or zimberelimab or start of a new anticancer therapy.

Number of participants in combination cohorts with treatment-related adverse events as assessed by CTCAE v4.

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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1, A-1EXPERIMENTALMonotherapy Dose Escalation
Part 1, A-2EXPERIMENTALBackfill
Part 1, BEXPERIMENTALDose escalation, COM503 in combination with a fixed dose of zimberelimab.
Part 2, AEXPERIMENTALDose expansion, COM503 monotherapy
Part 2, BEXPERIMENTALDose expansion, COM503 in combination with a fixed dose of zimberelimab.
Interventions
NameTypeDescription
COM503DRUGIntravenous Infusion
ZimberelimabDRUGIntravenous infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Participants with histologically/cytologically confirmed advanced recurrent or metastatic solid tumor malignancy * Part 1 (dose escalation): Participants must have had disease progression on or following all available standard of care (SOC) therapies known to confer clinical b...

Countries:United StatesIsrael
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06759649primaryCompletionDate: changed
LOWMay 24, 2026NCT06759649studyFirstPostDate: changed