๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-13

Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors (NCT06425926)

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

๐ŸŸข Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Georgiamune Inc

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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).

Who can join: Review the eligibility criteria below.

Location: HonorHealth Research Institute โ€” Scottsdale, Arizona

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (11 Sites)

  • HonorHealth Research Institute โ€” Scottsdale, Arizona
  • Comprehensive Blood and Cancer Center โ€” Bakersfield, California
  • Providence Medical Foundation โ€” Fullerton, California
  • The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate โ€” Los Angeles, California
  • UCSF Helen Diller Family Comprehensive Cancer Center โ€” San Francisco, California
  • Massachusetts General Hospital โ€” Boston, Massachusetts
  • Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana โ€” Billings, Montana
  • Weill Cornell Medicine - New York Presbyterian Hospital โ€” New York, New York
  • University of Cincinnati Cancer Center โ€” Cincinnati, Ohio
  • Tennessee Oncology, PLLC โ€” Nashville, Tennessee
  • Virginia Commonwealth University โ€” Richmond, Virginia

๐Ÿ“ž Contact the Study Coordinator

Phone: (661) 616-6453

Email: jayadev.sureddi@cbcc.global

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—