Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06759649

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

Led by Compugen Ltd · Updated on 2026-02-27

200

Participants Needed

11

Research Sites

149 weeks

Total Duration

On this page

Sponsors

C

Compugen Ltd

Lead Sponsor

G

Gilead Sciences

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants with confirmed advanced recurrent or metastatic solid tumor malignancy
  • For dose escalation: disease progression after all standard care therapies
  • For dose expansion: disease progression after at least one standard therapy, or standard therapy ineffective, intolerable, or inappropriate, or investigational agent recognized as standard care
  • Solid tumor measurable by CT or MRI per RECIST 1.1 criteria assessed by investigator
Not Eligible

You will not qualify if you...

  • History of another malignancy within 2 years unless treated with curative intent and low risk of recurrence (e.g., nonmelanoma skin cancer, excised carcinoma in situ)
  • Use of immunosuppressive systemic medications (e.g., steroids >10 mg/day prednisone) within 2 weeks before trial treatment
  • Known active central nervous system metastases or leptomeningeal disease
  • Active bacterial, fungal, or viral infection requiring systemic treatment
  • Symptomatic ascites or pleural effusion needing drainage within 2 weeks before trial treatment
  • Active hepatitis B, hepatitis C, or HIV infection
  • Any medical condition posing undue risk per investigator or sponsor judgement

AI-Screening

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Trial Site Locations

Total: 11 locations

1

Yale- New Haven Hospital- Yale Cancer Center

New Haven, Connecticut, United States, 06510

Actively Recruiting

2

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 0221502215

Actively Recruiting

3

START Midwest

Grand Rapids, Michigan, United States, 49546

Actively Recruiting

4

The West Clinic, PLCC dba West Cancer Center

Germantown, Tennessee, United States, 38138

Actively Recruiting

5

NEXT Oncology San Antonio

San Antonio, Texas, United States, 78229

Actively Recruiting

6

START

San Antonio, Texas, United States, 78229

Actively Recruiting

7

NEXT Oncology Virginia

Fairfax, Virginia, United States, 22031

Actively Recruiting

8

Rambam Health Care Campus

Haifa, Israel, Israel, 3109601

Actively Recruiting

9

Hadassah University Medical Center- Ein Kerem

Jerusalem, Israel, Israel, 9112001

Actively Recruiting

10

Rabin Medical Center

Petah Tikva, Israel, Israel, 4941492

Actively Recruiting

11

The Chaim Sheba Medical Center

Ramat Gan, Israel, Israel, 5465601

Actively Recruiting

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Research Team

M

Michelle Chief Medical Officer, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

5

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