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Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors
NCT06425926 · View on ClinicalTrials.gov ↗
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 Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2024-05-09 |
| Est. Completion | 2026-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06425926
The ClinicalTrials.gov registry entry for NCT06425926 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 117 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgiamune, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06425926 reports 11 study locations spanning 8 distinct geographic areas — top geographies include California, Arizona, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06425926?
The interventions under investigation include: Anti-PD-1 monoclonal antibody (DRUG), GIM-531 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06425926?
This trial is sponsored by Georgiamune, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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