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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: Recruiting Phase 1 study of Solid Tumor and Melanoma Stage IV, sponsored by Georgiamune.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
To assess incidence and severity of AE / SAEs and tolerability assessed by CTCAE grading
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 |
What NCT06425926 shows while recruiting
NCT06425926 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (47% lower).
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 lists 11 locations in 8 states (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.
Learn More About Clinical Trials
Similar trials for Solid Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06425926's enrollment target sits among peer trials
117 77th of 196 higher than 119 of 196 other Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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