RecruitingPhase 1Phase 2NCT06425926

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


Sponsor

Georgiamune Inc

Enrollment

117 participants

Start Date

May 9, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a phase 1 safety and tolerability study of a new drug called GIM-531 in people with advanced solid tumors that have progressed after standard therapies. The main goal is to determine the safest dose and assess any side effects. **You may be eligible if...** - You have a locally advanced or metastatic solid tumor that has progressed despite standard treatment, or no standard treatment exists - You are in good overall health (ECOG 0–1) - Your heart, kidney, and liver function meet study requirements - You are able to provide a tumor biopsy or have recent archived tumor tissue - You are willing to use contraception during and after treatment **You may NOT be eligible if...** - You have participated in another experimental drug study within 4 weeks (or 5 drug half-lives) - You are pregnant - Your organ function is significantly impaired - You are unable to comply with study visits and procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGIM-531

GIM-531 administered orally daily

DRUGAnti-PD-1 monoclonal antibody

Continued treatment with anti-PD-1 therapy


Locations(11)

HonorHealth Research Institute

Scottsdale, Arizona, United States

Comprehensive Blood and Cancer Center

Bakersfield, California, United States

Providence Medical Foundation

Fullerton, California, United States

The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate

Los Angeles, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana

Billings, Montana, United States

Weill Cornell Medicine - New York Presbyterian Hospital

New York, New York, United States

University of Cincinnati Cancer Center

Cincinnati, Ohio, United States

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Virginia Commonwealth University

Richmond, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06425926


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