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GIM-122 for Advanced Solid Malignancies

This study is testing a new treatment called GIM-122 for people with advanced solid tumors (cancers that form in solid organs). GIM-122 is a type of monoclonal antibody, which is a protein designed to target specific cells or substances in the body. It works as a checkpoint inhibitor, which means it helps the body's immune system fight cancer. The main goals of this study are to find out how safe GIM-122 is, what side effects it might cause, and what the highest safe dose is. To join, you need to be at least 18 years old, have a good general health status, and have advanced solid cancer that has been confirmed by a biopsy. This study is currently open and plans to enroll 111 participants.

Study design
This is a Phase 1/2, open-label study, meaning both you and your doctors will know you are receiving GIM-122. It will involve a dose escalation to find the best dose, followed by an expansion phase.
What's involved
GIM-122 will be given intravenously (through a vein) either once every 3 weeks or once every 2 weeks. You will need to have laboratory tests done within 28 days before starting treatment to check your heart, kidney, and liver function.
Compensation
Not stated in the trial record.
Follow-up
The study will track dose-limiting toxicities, maximum tolerated dose, and recommended Phase 2 dose for GIM-122 for 18 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06028074

Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies

Recruiting
PHASE1Ages 18+InterventionalTreatment
Georgiamune Inc
~111 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:GIM122

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose limiting toxicities [DLT] with GIM-122
Measured over 18 months
+5 more outcomes measured

Conditions

Advanced Solid Malignancies

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Solid Neoplasm

NCT06028074

Where you'd take part

This study runs at 11 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Florida Cancer Specialists

    Sarasota, Floridastudy coordinator listed

    Recruiting

  • NEXT Oncology Dallas

    Irving, Texasstudy coordinator listed

    Recruiting

  • Norton Cancer Institute

    Louisville, Kentuckystudy coordinator listed

    Recruiting

  • Rutgers Cancer Institute of NJ

    New Brunswick, New Jerseystudy coordinator listed

    Recruiting

  • Tennessee Oncology, PLLC

    Nashville, Tennesseestudy coordinator listed

    Recruiting

  • Texas Oncology - Baylor Sammons Cancer Center

    Dallas, Texasstudy coordinator listed

    Recruiting

  • The Angeles Clinic and Research Institute

    Los Angeles, Californiastudy coordinator listed

    Recruiting

  • UCLA Hematology/Oncology

    Los Angeles, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Omid Hamid, MD · PRINCIPAL_INVESTIGATOR · The Angeles Clinic and Research Institute

Who to contact

LumaBridge CRO
[email protected]
210-563-8441
Email the study team

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Eligibility criteria

Inclusion

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

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
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).

What this trial measures

  • Dose limiting toxicities [DLT] with GIM-12218 months

    To identify dose limiting toxicities \[DLT\] with GIM-122

  • Maximum tolerated dose [MTD] of GIM-12218 months

    To identify maximum tolerated dose \[MTD\] of GIM-122

  • Recommended Phase 2 Dose [RP2D] of GIM-12218 Months

    To identify Recommended Phase 2 Dose \[RP2D\] of GIM-122

  • Overall response rate (ORR) -Part B of the study36 months

    To identify overall response rate (ORR) in patients with advanced malignant tumors who are refractory/ resistant to PD-1 and PD-L1 therapy

  • Anti-tumor activity of GIM-12236 months

    To assess anti-tumor activity of GIM-122 as a single agent in patients with advanced malignant tumors who are refractory/ resistant to PD-1 and PD-L1 therapy

  • Incidence and severity of AE / SAEs and tolerability36 months

    To assess incidence and severity of AE / SAEs and tolerability assessed by CTCAE grading