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

NCT06425926 Phase 1/Phase 2 RECRUITING

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).

Details

Lead sponsor	Georgiamune Inc
Phase	Phase 1/Phase 2
Status	RECRUITING
Enrolment	117
Start date	2024-05-09
Completion	2027-11

Conditions

• Melanoma Stage IV
• Solid Tumor

Interventions

• GIM-531
• Anti-PD-1 monoclonal antibody

Primary outcomes

• Incidence and severity of adverse events (AEs) / serious adverse events (SAEs) and tolerability — Through study completion, an average of 1 year
  To assess incidence and severity of AE / SAEs and tolerability assessed by CTCAE grading
• Dose limiting toxicities (DLT) with GIM-531 — 21 days
  To identify dose limiting toxicities with GIM-531

Countries

United States