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

NCT06425926 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2026-03-27

No results posted yet for this study

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).

Conditions

Interventions

DRUG

GIM-531

GIM-531 administered orally daily

DRUG

Anti-PD-1 monoclonal antibody

Continued treatment with anti-PD-1 therapy

Sponsors & Collaborators

  • Georgiamune Inc

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-09
Primary Completion
2026-12-31
Completion
2027-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06425926 on ClinicalTrials.gov