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COM503

Phase 1

Neoplasm | Small molecule | Oncology |Compugen Ltd.|Last Updated: Aug 12, 2026

Target and mechanism

Molecular targetIL-18
Target classBinding Protein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment200

FDA Designations

No designations recorded

Clinical trial landscape

COM503 · 1 trial · 2 indications

Phase 1 1
NCT06759649A Clinical Trial to Assess COM503 in Participants With Advanced Solid MalignanciesNeoplasm
RECRUITING200 Analytics
PHASE1RECRUITING
A Clinical Trial to Assess COM503 in Participants With Advanced Solid Malignancies
NeoplasmUnlock trial analytics

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 to 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)

LOWAug 12, 2026NCT06759649lastUpdatePostDate: changed
LOWAug 12, 2026NCT06759649lastUpdatePostDate: changed

Frequently asked questions about COM503

What is COM503 used for?

COM503 is an investigational small molecule being developed for the treatment of neoplasms, including advanced solid malignancies. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does COM503 target?

COM503 targets IL-18, a binding protein involved in immune signaling. By modulating IL-18 activity, the drug aims to affect the tumor microenvironment in oncology indications. The specific mechanism of action is under investigation in clinical trials.

Who makes COM503?

COM503 is being developed by Compugen Ltd., a biopharmaceutical company listed on the stock exchange under the ticker symbol CGEN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced solid tumors.

What phase is COM503 in?

COM503 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies. The ongoing Phase 1 trial is recruiting participants to assess the drug in advanced solid malignancies.

What clinical trials is COM503 in?

COM503 is being evaluated in a Phase 1 clinical trial with the identifier NCT06759649. This trial is recruiting approximately 200 participants with advanced solid malignancies in the United States and Israel. The study is open to adults aged 18 years and older.

Is COM503 the same as other drugs?

COM503 is a distinct investigational drug developed by Compugen Ltd. It is not known to be the same as any other approved or investigational medication. Its unique target, IL-18 binding protein, differentiates it from other oncology therapies.