Please sign in to follow a disease.
Can a Dual-Action antibody outsmart resistant tumors?
NCT ID NCT06028074
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 Hide 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).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced solid malignancies are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
11 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
-
Contact
Email: •••••@•••••
Locations
-
Florida Cancer Specialists
RECRUITINGSarasota, Florida, 34232, United States
-
NEXT Oncology Dallas
RECRUITINGIrving, Texas, 75039, United States
-
Norton Cancer Institute
RECRUITINGLouisville, Kentucky, 40202, United States
-
Rutgers Cancer Institute of NJ
RECRUITINGNew Brunswick, New Jersey, 08903, United States
-
Tennessee Oncology, PLLC
RECRUITINGNashville, Tennessee, 37203, United States
-
Texas Oncology - Baylor Sammons Cancer Center
RECRUITINGDallas, Texas, 75246, United States
-
The Angeles Clinic and Research Institute
RECRUITINGLos Angeles, California, 90025, United States
-
UCLA Hematology/Oncology
RECRUITINGLos Angeles, California, 90095, United States
-
UCSF Helen Diller Family Comprehensive Cancer Center
RECRUITINGSan Francisco, California, 94143, United States
-
USC/Norris Comprehensive Cancer Center
RECRUITINGLos Angeles, California, 90033, United States
-
Virginia Commonwealth University
RECRUITINGRichmond, Virginia, 23298, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Oral drug that targets two cancer drivers tested in first human study
- Mitochondria-Targeting drug gamitrinib tested for first time in humans
- Can a Two-Drug combo outsmart advanced cancer?
- Can an experimental pill boost cancer immunotherapy? early trial puts HG146 to the test
- New injectable drug tested for safety in Hard-to-Treat solid tumors
- New antibody drug conjugate tested against advanced cancers