NCT06028074 · Georgiamune Inc
Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies
What this study 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, how the drug moves through the body and clinical effectiveness of given through a vein (IV) (IV) administration of GIM-122 in adults with advanced malignancies.
View original scientific description
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.
Interventions
DRUG
GIM122
GIM-122 administered IV once every 3 weeks or every 2 weeks
Primary outcome measures
Dose limiting toxicities [DLT] with GIM-122
Time frame: 18 months
To identify dose limiting toxicities \[DLT\] with GIM-122
Maximum tolerated dose [MTD] of GIM-122
Time frame: 18 months
To identify maximum tolerated dose \[MTD\] of GIM-122
Recommended Phase 2 Dose [RP2D] of GIM-122
Time frame: 18 Months
To identify Recommended Phase 2 Dose \[RP2D\] of GIM-122
Overall response rate (ORR) -Part B of the study
Time frame: 36 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-122
Time frame: 36 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 tolerability
Time frame: 36 months
To assess incidence and severity of AE / SAEs and tolerability assessed by CTCAE grading
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Los Angeles, California
- San Francisco, California
- Sarasota, Florida
- Louisville, Kentucky
- New Brunswick, New Jersey
- Nashville, Tennessee
- Dallas, Texas
- Irving, Texas
- Richmond, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 11, 2025 · Source of record for eligibility and locations