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New drug COM503 enters first human trial for advanced cancers

NCT ID NCT06759649

Disease control Sponsor: Compugen Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This early-stage trial tests a new drug called COM503, alone or with another drug zimberelimab, in 200 people with advanced solid tumors that have not responded to standard treatments. The main goal is to check safety and find the right dose. It is a first-in-human study, so effectiveness is not yet known.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
COM503 (a drug given by IV) and zimberelimab (another drug given by IV)
What this could lead to
If it works, this could point toward a new treatment option for people with advanced solid tumors who have run out of standard therapies.
What could go wrong
This is a very early Phase 1 trial, so the main goal is safety, not effectiveness. It may not work, and side effects are unknown. Only 200 people are enrolled, so results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 benefit. * Part 2 (dose expansion): Participants may be enrolled following disease progression that has progressed after at least 1 available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized SOC. * Participants must have a solid tumor measurable by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria by investigator assessment Exclusion Criteria: * History of another malignancy within 2 years prior to the first trial intervention administration (unless the malignancy was treated with curative intent with low risk of recurrence \[e.g., nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar\] which are allowed to enroll). * Therapy with Immunosuppressive doses of systemic medications, such as steroids (doses \>10 mg/day prednisone or equivalent daily) within 2 weeks before trial intervention administration * Have known active central nervous system (CNS) metastases and/or leptomeningeal disease (LMD). * Active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires systemic antibiotics, antifungals, or antivirals, respectively. * Ascites or pleural effusion that is symptomatic and/or requiring drainage within 2 weeks prior to the first trial intervention administration. * Have active hepatitis B virus (HBV) or hepatitis C virus (HCV), or participants with human immunodeficiency virus (HIV). * Any medical condition that, in the investigator's or sponsor's opinion, poses an undue risk to the participant's participation in the trial.

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Conditions

The condition(s) this trial relates to.

cancer neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cancer, malignant tumors Neoplasm

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 0221502215, United States

  • Hadassah University Medical Center- Ein Kerem

    RECRUITING

    Jerusalem, Israel, 9112001, Israel

  • NEXT Oncology San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • NEXT Oncology Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Rabin Medical Center

    RECRUITING

    Petah Tikva, Israel, 4941492, Israel

  • Rambam Health Care Campus

    RECRUITING

    Haifa, Israel, 3109601, Israel

  • START Midwest

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • START- San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • The Chaim Sheba Medical Center

    RECRUITING

    Ramat Gan, Israel, 5465601, Israel

  • The West Clinic, PLCC dba West Cancer Center

    RECRUITING

    Germantown, Tennessee, 38138, United States

  • Yale- New Haven Hospital- Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.