A Phase 1/2, Open-label, Multi-center Study of the Safety, Tolerability, and Efficacy of GIM-531 as a Single Agent and in Combination With Anti-PD-1 in Advanced Solid Tumors
Georgiamune Inc
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).
Description
GIM531-CT01 is a Phase 1/2 open label, first-in-human, multicenter study. The Phase 1 portion will include a dose escalation with GIM-531 administered as a single agent. Additionally, there will be a dose expansion portion at the safety-cleared dose levels with participants allocated 1:1 within the proposed therapeutic range to accrue additional data for determining the safety profile, pharmacokinetics (PK) profile, pharmacodynamic (PD) effects and early anti-tumor activity of GIM-531. In Phase 2, GIM-531will be administered to participants with advanced/metastatic cutaneous melanoma who have…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugGIM-531
GIM-531 administered orally daily
- DrugAnti-PD-1 monoclonal antibody
Continued treatment with anti-PD-1 therapy
Locations (11)
- HonorHealth Research InstituteScottsdale, Arizona
- Comprehensive Blood and Cancer CenterBakersfield, California
- Providence Medical FoundationFullerton, California
- The Angeles Clinic and Research Institute, A Cedars-Sinai AffiliateLos Angeles, California
- UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California
- Massachusetts General HospitalBoston, Massachusetts