NCT06759649

A Clinical Trial to Assess COM503 in Participants With Advanced Solid Malignancies

A First-in-Human, Phase 1 Dose Escalation and Dose Expansion Trial to Assess the Safety and Tolerability of COM503 as Monotherapy and in Combination Therapy in Participants With Advanced Solid Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Compugen Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall goal of this first-in-human (FIH) clinical trial is to learn about the safety and dosing of COM503 when given alone or in combination with zimberelimab in participants with advanced solid tumors. The primary objectives of this study are: * To assess the safety and tolerability of COM503 as monotherapy and COM503 in combination with zimberelimab in participants with advanced solid tumors. * To identify the maximum tolerated dose (MTD) / maximum administered dose (MAD) and/or the recommended phase 2 dose (RP2D) of COM503 as monotherapy and in combination with zimberelimab in participants with advanced solid tumors.

Conditions

• Neoplasm
• Cancer, Malignant Tumors

Interventions

Type	Name	Description
DRUG	COM503	Intravenous Infusion
DRUG	Zimberelimab	Intravenous infusion

Timeline

• Start date: 2025-01-07
• Primary completion: 2027-11-22
• Completion: 2027-11-22
• First posted: 2025-01-06
• Last updated: 2026-02-27

Locations

11 sites across 2 countries: United States, Israel

Regulatory

• FDA-regulated drug study