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NCT06425926 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Solid Tumor and Melanoma Stage IV, sponsored by Georgiamune.

Recruiting
Registry status
Phase 1
Development phase
117
Enrollment target
11
Study locations

NCT06425926 is a Phase 1 study of Solid Tumor and Melanoma Stage IV that is actively recruiting participants, run by Georgiamune. The registered enrollment target is 117 participants, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (47% lower). The trial reports 11 study locations across 8 states.

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The verdict

NCT06425926, a Phase 1 study of Solid Tumor and Melanoma Stage IV, is actively recruiting participants, sponsored by Georgiamune.

RECRUITING
Registry status
Phase 1
Development phase
117 participants
Enrollment target
11
Study locations

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).

Interventions

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

Study Locations (11)

California

  • Comprehensive Blood and Cancer Center - Bakersfield
  • Providence Medical Foundation - Fullerton
  • The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate - Los Angeles
  • UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco

Arizona

  • HonorHealth Research Institute - Scottsdale

Massachusetts

  • Massachusetts General Hospital - Boston

Montana

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

New York

  • Weill Cornell Medicine - New York Presbyterian Hospital - New York

Ohio

  • University of Cincinnati Cancer Center - Cincinnati

Tennessee

  • Tennessee Oncology, PLLC - Nashville

Virginia

  • Virginia Commonwealth University - Richmond

Trial Details

FieldValue
Enrollment Target 117 participants
Start Date 2024-05-09
Est. Completion 2026-11
Phase Phase 1

Sponsor

Georgiamune

2 total trials

What the Registry Record Tells You About NCT06425926

The ClinicalTrials.gov registry entry for NCT06425926 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 117 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (47% lower). The listed sponsor is Georgiamune, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Solid Tumor appearing as the primary indexed condition, and to 2 interventions - of which Anti-PD-1 monoclonal antibody is the first listed.

NCT06425926 reports 11 study locations spanning 8 distinct geographic areas - top geographies include California, Arizona, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT06425926 about?

NCT06425926 is a clinical study titled "Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors". 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).

What is the current status of trial NCT06425926?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 117 participants. The study started on 2024-05-09. Estimated completion is 2026-11.

What conditions does trial NCT06425926 study?

This clinical trial studies the following conditions: Solid Tumor, Melanoma Stage IV.

What interventions are being tested in trial NCT06425926?

The interventions under investigation include: Anti-PD-1 monoclonal antibody (DRUG), GIM-531 (DRUG).

Who is sponsoring clinical trial NCT06425926?

This trial is sponsored by Georgiamune, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06425926 being conducted?

This trial has 11 study locations across Arizona, California, Massachusetts, Montana, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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