Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies
NCT ID: NCT06028074
Last Updated: 2025-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
111 participants
INTERVENTIONAL
2023-12-12
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intravenous administration of GIM-122
GIM-122
GIM122
GIM-122 administered IV once every 3 weeks or every 2 weeks
Interventions
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GIM122
GIM-122 administered IV once every 3 weeks or every 2 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Georgiamune Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Omid Hamid, MD
Role: PRINCIPAL_INVESTIGATOR
The Angeles Clinic and Research Institute
Locations
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The Angeles Clinic and Research Institute
Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCLA Hematology/Oncology
Los Angeles, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Rutgers Cancer Institute of NJ
New Brunswick, New Jersey, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Texas Oncology - Baylor Sammons Cancer Center
Dallas, Texas, United States
NEXT Oncology Dallas
Irving, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Kandyce Treijo
Role: primary
Charles Cowey, MD
Role: primary
Stephanie Cannon
Role: backup
Alexis Praytor
Role: primary
Other Identifiers
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GIM122-CT01
Identifier Type: -
Identifier Source: org_study_id
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