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Can a Dual-Action antibody outsmart resistant tumors?

NCT ID NCT06028074

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This early-stage trial is testing an investigational drug called GIM-122 in adults with advanced solid tumors that have not responded to standard treatments, including PD-1/PD-L1 inhibitors. GIM-122 is a special antibody designed to fight cancer in two ways. The study aims to find the safest dose and see if the drug can shrink tumors. It is the first time this drug is being given to humans.

What this could mean

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

Active substance
GIM-122, an investigational dual-functioning monoclonal antibody given intravenously
What this could lead to
If successful, GIM-122 could offer a new treatment option for people with advanced solid tumors that have stopped responding to existing immunotherapies.
What could go wrong
This is an early-phase trial, so the drug may not be safe or effective. It is the first time GIM-122 is tested in humans, and side effects are unknown.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 111 people

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

Started

Dec 2023

Expected to finish

Dec 2026

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: General * Written informed consent * ECOG performance status 0-1. * Laboratory assessment 28 days prior to enrollment for assessment of acceptable cardiac, renal and hepatic functions * Recommended Double methods of contraception 90-days post treatment Cancer Specific * Histologically or cytologically confirmed locally advanced/unresectable or metastatic solid tumor * Received FDA approved treatment of PD-1 inhibitor or PD-L1 inhibitor for advance malignant tumors and have progressed/relapsed, are refractory, or intolerant * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 * Had prior therapy with PD-1/PD-L1 inhibitors. Other checkpoint inhibitors (ie, CTLA4, LAG3) are permitted if they did not lead to treatment discontinuation * No other lines of therapy that are available Exclusion Criteria: General * Enrolled in any other interventional clinical trial, starting within 4 weeks of the first dose of GIM-122 and throughout the duration of the study, or is receiving other therapy directed at their malignancy * Women who are pregnant or breastfeeding * History of cardiac issues, pulmonary embolism, active and clinically significant bacterial, fungal, or viral infection ≤ 6 months prior to dosing * Contraindications to the imaging assessments or other study procedures that subjects will undergo or any medical or social condition that, in the opinion of the investigator, might place a subject at an increased risk, affect compliance, or confound safety or other clinical study data interpretation Cancer Specific * Current second malignancy at other sites * Leptomeningeal disease * Spinal cord compression * Symptomatic or new or enlarging central nervous system (CNS) metastases Treatment-specific Exclusion Criteria * Ongoing toxicity \> Grade 1 from prior therapy according to Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 * Has undergone a major surgery \< 1 month prior to administration of GIM-122 * Has received radiation therapy within 2 weeks prior to administration of GIM-122 * Has undergone or is anticipated to undergo organ transplantation including allogeneic or autologous stem cell transplantation at any time * Has received systemic anti-cancer therapy within 2 weeks and cytotoxic agents that have a major delayed toxicity within 4 weeks, of the first dose of GIM-122 * Prior treatment with other immune modulating agents within \< 4 weeks prior to the first dose of GIM-122. * Has a diagnosis of immunodeficiency, either primary or acquired * Has received treatment with systemic steroids or any form of immunosuppressive therapy within 14 days prior to administration of GIM-122 * Has active or prior history of autoimmune disease, including ulcerative colitis and Crohn's disease, or any condition that requires systemic steroids. * Has a known severe intolerance to or hypersensitivity reactions to monoclonal antibodies, Fc-bearing proteins, or IV immunoglobulin preparations; prior history of human anti-human antibody response; known allergy to any of the study medications, or excipients in the various formulations of any agent. * Has received live vaccines within 30 days of study initiation (inactivated vaccines are allowed; seasonal vaccines should be up to date \> 30 days prior to administration of GIM-122).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Florida Cancer Specialists

    RECRUITING

    Sarasota, Florida, 34232, United States

  • NEXT Oncology Dallas

    RECRUITING

    Irving, Texas, 75039, United States

  • Norton Cancer Institute

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Rutgers Cancer Institute of NJ

    RECRUITING

    New Brunswick, New Jersey, 08903, United States

  • Tennessee Oncology, PLLC

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Texas Oncology - Baylor Sammons Cancer Center

    RECRUITING

    Dallas, Texas, 75246, United States

  • The Angeles Clinic and Research Institute

    RECRUITING

    Los Angeles, California, 90025, United States

  • UCLA Hematology/Oncology

    RECRUITING

    Los Angeles, California, 90095, United States

  • UCSF Helen Diller Family Comprehensive Cancer Center

    RECRUITING

    San Francisco, California, 94143, United States

  • USC/Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23298, United States

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