Status:
RECRUITING
Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies
Lead Sponsor:
Georgiamune Inc
Conditions:
Advanced Solid Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 clini...
Detailed Description
This is a Phase 1/2, open label, first-in-human (FIH), multicenter, dose escalation study with enrichments and dose expansion cohorts at RP2D, designed to evaluate the safety, tolerability, PK, pharma...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT06028074
Start Date
December 12 2023
End Date
December 1 2026
Last Update
July 11 2025
Active Locations (11)
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1
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
2
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
3
UCLA Hematology/Oncology
Los Angeles, California, United States, 90095
4
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94143