REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors
Completed · Phase 1/Phase 2
Conditions studied: FGFR2 Amplification, FGFR2 Gene Mutation, FGFR2 Gene Fusion/Rearrangement, FGFR2 Gene Translocation, FGFR2 Gene Activation, Intrahepatic Cholangiocarcinoma, Cholangiocarcinoma, Other Solid Tumors, Adult
In brief
This is a Phase 1/2, open-label, FIH study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDy), and antineoplastic activity of RLY-4008, a potent and highly selective FGFR2 inhibitor, in patients with unresectable or metastatic cholangiocarcinoma (CCA) and other solid tumors. The study consists of 4 parts: a dose escalation (Part 1), a dose expansion (Part 2), and an extension (Part 3) and a rollover (Part 4).
Key facts
- Study ID
- NCT04526106
- Run by
- Elevar Therapeutics
- People needed
- 490
- Starts
- 2020-09-02
- Expected to finish
- 2025-09-05
- Last updated by the study team
- 2026-02-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- The University of Alabama at Birmingham — Birmingham, Alabama, United States
- Mayo Clinic — Phoenix, Arizona, United States
- USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
- UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
- Mayo Clinic — Jacksonville, Florida, United States
- Moffitt Cancer Center — Tampa, Florida, United States
- Winship Cancer Institute, Emory University — Atlanta, Georgia, United States
- University of Chicago Medical Center — Chicago, Illinois, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Taussig Cancer Institute Cleveland Clinic — Cleveland, Ohio, United States
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
- Texas Oncology — Dallas, Texas, United States
- The University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States
- Huntsman Cancer Institute, University of Utah — Salt Lake City, Utah, United States
- Virginia Mason Medical Center — Seattle, Washington, United States
- St. Vincent's Hosptial Sydney — Darlinghurst, Australia
- Linear Clinical Research Ltd — Nedlands, Australia
- Icon Cancer Care South Brisbane — South Brisbane, Australia
- Institut Bergonie — Bordeaux, France
- Centre Georges François Leclerc — Dijon, France
- Centre Leon Berard — Lyon, France
- Gustave Roussy Cancer Campus — Paris, France
Full record on ClinicalTrials.gov
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