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

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Solid Malignancies

In brief

GIM-122 is a first-in-class, humanized immunoglobulin G1 kappa dual functioning monoclonal antibody (DFA). This phase 1 / 2 study plans to evaluate the safety, tolerability, pharmacokinetics and clinical efficacy of intravenous (IV) administration of GIM-122 in adults with advanced malignancies.

Key facts

Study ID

NCT06028074

Run by

Georgiamune Inc

People needed

111

Starts

2023-12-12

Expected to finish

2026-12-01

Last updated by the study team

2025-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• The Angeles Clinic and Research Institute — Los Angeles, California, United States (enrolling)
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
• UCLA Hematology/Oncology — Los Angeles, California, United States (enrolling)
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States (enrolling)
• Florida Cancer Specialists — Sarasota, Florida, United States (enrolling)
• Norton Cancer Institute — Louisville, Kentucky, United States (enrolling)
• Rutgers Cancer Institute of NJ — New Brunswick, New Jersey, United States (enrolling)
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States (enrolling)
• Texas Oncology - Baylor Sammons Cancer Center — Dallas, Texas, United States (enrolling)
• NEXT Oncology Dallas — Irving, Texas, United States (enrolling)
• Virginia Commonwealth University — Richmond, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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