Evaluating GIM-122 for advanced solid tumors
A First-in-Human, Open-Label, Phase 1/2 Dose-Escalation With Enrichment and Dose-Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of GIM-122 as a Single Agent in Adult Subjects With Advanced Solid Malignancies
This study is testing a new treatment called GIM-122 for adults with advanced solid tumors to see how safe it is and how well it works.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 111 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Georgiamune Inc Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 11 sites (Los Angeles, California and 10 other locations) |
| Trial ID | NCT06028074 on ClinicalTrials.gov |
What this trial studies
This study evaluates GIM-122, a first-in-class monoclonal antibody, in adults with advanced solid malignancies. It is a Phase 1/2, open-label, multicenter trial that will assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of GIM-122 administered intravenously. The study consists of two parts: a dose escalation phase to determine the optimal dose and a dose expansion phase to further evaluate its effects in a larger cohort of patients.
Who should consider this trial
Good fit: Ideal candidates include adults with histologically confirmed advanced solid tumors who have previously received PD-1 or PD-L1 inhibitors and have shown disease progression.
Not a fit: Patients who are currently enrolled in other interventional clinical trials or have other available lines of therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.
How similar studies have performed: Other studies involving monoclonal antibodies for advanced malignancies have shown promising results, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: 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 this trial is running
Los Angeles, California and 10 other locations
- The Angeles Clinic and Research Institute — Los Angeles, California, United States (Recruiting)
- USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
- UCLA Hematology/Oncology — Los Angeles, California, United States (Recruiting)
- UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States (Recruiting)
- Florida Cancer Specialists — Sarasota, Florida, United States (Recruiting)
- Norton Cancer Institute — Louisville, Kentucky, United States (Recruiting)
- Rutgers Cancer Institute of NJ — New Brunswick, New Jersey, United States (Recruiting)
- Tennessee Oncology, PLLC — Nashville, Tennessee, United States (Recruiting)
- Texas Oncology - Baylor Sammons Cancer Center — Dallas, Texas, United States (Recruiting)
- NEXT Oncology Dallas — Irving, Texas, United States (Recruiting)
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Omid Hamid, MD — The Angeles Clinic and Research Institute
- Study coordinator: LumaBridge CRO
- Email: contact@lumabridge.com
- Phone: 210-563-8441
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.