Actively Recruiting
Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies
Led by Georgiamune Inc · Updated on 2025-07-11
111
Participants Needed
11
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- ECOG performance status 0-1
- Laboratory tests within 28 days before enrollment showing acceptable heart, kidney, and liver function
- Use of effective contraception methods for 90 days after treatment
- Histologically or cytologically confirmed advanced, unresectable, or metastatic solid tumor
- Prior treatment with FDA-approved PD-1 or PD-L1 inhibitors with disease progression, relapse, intolerance, or refractory status
- Measurable disease per RECIST version 1.1
- Previous therapy with PD-1/PD-L1 inhibitors; other checkpoint inhibitors allowed if they did not cause treatment discontinuation
- No other available lines of therapy
You will not qualify if you...
- Participation in another interventional clinical trial within 4 weeks before starting GIM-122 or receiving other cancer treatments during this study
- Pregnancy or breastfeeding
- History of heart problems, pulmonary embolism, or serious infections within 6 months before dosing
- Contraindications to required imaging or procedures or any conditions increasing risk or affecting study compliance
- Current second malignancy at other sites
- Leptomeningeal disease
- Spinal cord compression
- Symptomatic or new/enlarging central nervous system metastases
- Ongoing toxicity greater than Grade 1 from prior therapy
- Major surgery within 1 month before GIM-122 administration
- Radiation therapy within 2 weeks before GIM-122
- Past or planned organ transplantation including stem cell transplant
- Systemic anti-cancer therapy within 2 weeks or cytotoxic agents with delayed toxicity within 4 weeks before GIM-122
- Immune modulating agents within less than 4 weeks before GIM-122
- Diagnosis of primary or acquired immunodeficiency
- Systemic steroids or immunosuppressive therapy within 14 days before GIM-122
- Active or past autoimmune disease requiring systemic steroids
- Known severe intolerance or allergy to monoclonal antibodies, Fc proteins, IV immunoglobulin, or study medications
- Live vaccines within 30 days before study start; inactivated vaccines allowed with timing considerations
AI-Screening
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Trial Site Locations
Total: 11 locations
1
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
Actively Recruiting
2
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
UCLA Hematology/Oncology
Los Angeles, California, United States, 90095
Actively Recruiting
4
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94143
Actively Recruiting
5
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Actively Recruiting
6
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
Actively Recruiting
7
Rutgers Cancer Institute of NJ
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
8
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
Actively Recruiting
9
Texas Oncology - Baylor Sammons Cancer Center
Dallas, Texas, United States, 75246
Actively Recruiting
10
NEXT Oncology Dallas
Irving, Texas, United States, 75039
Actively Recruiting
11
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
L
LumaBridge CRO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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