Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors
Public ClinicalTrials.gov record NCT06425926. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT06425926
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 117 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 8, 2024
- Primary completion
- Nov 30, 2026
- Completion
- Oct 31, 2027
- Last update posted
- Aug 13, 2026
2024 – 2027
United States locations
- U.S. sites
- 11
- U.S. states
- 8
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | Recruiting |
| Comprehensive Blood and Cancer Center | Bakersfield | California | 93309 | Recruiting |
| Providence Medical Foundation | Fullerton | California | 92835 | Recruiting |
| The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate | Los Angeles | California | 90025 | Recruiting |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94143 | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Recruiting |
| Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana | Billings | Montana | 59102 | Recruiting |
| Weill Cornell Medicine - New York Presbyterian Hospital | New York | New York | 10065 | Recruiting |
| University of Cincinnati Cancer Center | Cincinnati | Ohio | 45267 | Recruiting |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37203 | Recruiting |
| Virginia Commonwealth University | Richmond | Virginia | 23219 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06425926, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 13, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06425926 live on ClinicalTrials.gov.