Actively Recruiting
First-in-Human Phase 1 Trial to Assess Safety and Dose of COM503 Alone and With Zimberelimab in Advanced Solid Tumors
Led by Compugen Ltd · Updated on 2026-02-27
200
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Compugen Ltd
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying COM503 alone and in combination with zimberelimab in people with advanced solid tumors. This first-in-human clinical trial aims to understand the safety and best dose for these treatments when given by themselves or together. The study focuses on participants whose cancer has progressed despite available standard treatments or when standard options are not suitable. The trial includes several parts: dose escalation of COM503 alone and with a fixed dose of zimberelimab, backfill phases, and dose expansion phases for both monotherapy and combination therapy. COM503 and zimberelimab are both given as intravenous infusions. The study carefully increases doses to find the maximum tolerated or recommended dose for future studies. Participants will undergo imaging scans such as CT or MRI to measure their tumors. Safety and tolerability are closely monitored from the first dose until 90 days after the last dose or before starting new cancer therapy. The study involves regular assessments to track side effects and effectiveness of the treatments in controlling tumor growth. Participation duration varies depending on treatment response and safety outcomes.
CONDITIONS
Brief Title
A Clinical Trial to Assess COM503 in Participants With Advanced Solid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with confirmed advanced recurrent or metastatic solid tumor malignancy
- For dose escalation: disease progression after all available standard therapies
- For dose expansion: progression after at least one standard therapy, or standard treatment ineffective, intolerable, or inappropriate
- Tumor measurable by CT or MRI according to RECIST 1.1 criteria
- Age 18 years or older
You will not qualify if you...
- History of another malignancy within 2 years prior to trial intervention unless treated with low risk of recurrence
- Use of immunosuppressive systemic steroids above 10 mg/day prednisone or equivalent within 2 weeks before trial
- Known active central nervous system metastases or leptomeningeal disease
- Active uncontrolled bacterial, fungal, or viral infection
- Symptomatic ascites or pleural effusion requiring drainage within 2 weeks prior to trial
- Active hepatitis B, hepatitis C, or HIV infection
- Any medical condition posing undue risk to participation as judged by investigator or sponsor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From first dose until up to 90 days after last dose or start of new anticancer therapy
Participants receive COM503 alone or in combination with zimberelimab through intravenous infusions to assess safety and dosing.
Regular visits for infusions and safety monitoring per protocol
Duration - Up to 90 days after last treatment dose
Participants are monitored for safety for up to 90 days following the last dose of COM503 and/or zimberelimab or until starting new anticancer therapy.
Visits as scheduled for safety assessments
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
Research Team
M
Michelle Chief Medical Officer, MD
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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