๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-10

Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated Cholangiocarcinoma (NCT05874414)

Phase 1b/2a Study of GNS561 in Combination With Trametinib in Advanced KRAS Mutated Cholangiocarcinoma

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

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

This is an open-label, multicenter Phase 1b/2a study to evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of GNS561 in combination with trametinib in Advanced KRAS Mutated Cholangiocarcinoma after failure of standard-of-care first line therapy

Who can join: Review the eligibility criteria below.

Location: USC Norris Comprehensive Cancer Center โ€” Los Angeles, California

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)

  • USC Norris Comprehensive Cancer Center โ€” Los Angeles, California
  • LACN Aneheim Flagship Office โ€” Los Angeles, California
  • Orlando Health โ€” Orlando, Florida
  • Moffitt Cancer Center โ€” Tampa, Florida
  • University Of Chicago Medical Center โ€” Chicago, Illinois
  • Roswell Park Cancer Institute โ€” Buffalo, New York
  • Hospital of the University of Pennsylvania โ€” Philadelphia, Pennsylvania
  • University of Texas, MD Anderson Cancer Center โ€” Houston, Texas
  • University of Virginia Comprehensive Cancer Center โ€” Charlottesville, Virginia
  • Froedtert Hospital and the Medical College of Wisconsin โ€” Milwaukee, Wisconsin
  • Pan American Center for Oncology Trials, LLC โ€” Rio Piedras, Puerto Rico

๐Ÿ“ž Contact the Study Coordinator

Phone: +33320164092

Email: contact@genfit.com

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†—