Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors
GIM-531 is a first-in-class, orally bioavailable small molecule that is being developed for the treatment of advanced solid tumors as a single agent and rescue therapy. GIM-531 exhibits its primary effect through selective inhibition of regulatory T-cells (Tregs).
| Condition(s) | Melanoma Stage IV, Solid Tumor |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | GIM-531 is a first-in-class, orally bioavailable small molecule that is being developed for the treatment of advanced solid tumors as a single agent and rescue therapy. GIM-531 exhibits its primary effect through selective inhibition of regulatory T-cells (Tregs). |
| Who can participate | Key Inclusion Criteria: * Written informed consent * Cytologically or histologically confirmed locally advanced or metastatic solid tumor that has progressed on standard therapy or for which no standard therapy exist; or be intolerant of standard therapy * Have not received an experimental drug within 4 weeks or 5 half-lives (whichever is shorter) of study drug treatment or already be enrolled in a clinical study * ECOG performance status 0-1 * Laboratory and ECG assessments within 28 days of enrollment including acceptable cardiac, renal, and hepatic functions * Agree to baseline core needle biopsy or archival (within 12 months of screening) tumor submission; Note: Participants whose only site(s) of disease are in areas considered moderate or high risk for biopsy complications may be enro |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Georgiamune Inc |
| Locations | Scottsdale, Arizona, United States; Bakersfield, California, United States; Fullerton, California, United States; Los Angeles, California, United States; San Francisco, California, United States; Boston, Massachusetts, United States (+5 more sites) |
| Start date | 2024-05-09 |
| NCT ID | NCT06425926 |
| Official listing | https://clinicaltrials.gov/study/NCT06425926 |