NCT06425926

Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 117 (estimated)
• Sponsor: Georgiamune Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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 progressed following treatment with an anti-PD-1 therapy.

Conditions

• Melanoma Stage IV
• Solid Tumor

Interventions

Type	Name	Description
DRUG	GIM-531	GIM-531 administered orally daily
DRUG	Anti-PD-1 monoclonal antibody	Continued treatment with anti-PD-1 therapy

Timeline

• Start date: 2024-05-09
• Primary completion: 2026-12-01
• Completion: 2027-11-01
• First posted: 2024-05-23
• Last updated: 2026-03-27

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study