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NCT04526106 · ClinicalTrials.gov registry record · Phase 1
REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors
A Phase 1 study of Cholangiocarcinoma and Intrahepatic Cholangiocarcinoma, sponsored by Elevar Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 490
- Enrollment target
- 20
- Study locations
NCT04526106: Completed Phase 1 study of Cholangiocarcinoma and Intrahepatic Cholangiocarcinoma, sponsored by Elevar Therapeutics.
NCT04526106 is a Phase 1 study of Cholangiocarcinoma and Intrahepatic Cholangiocarcinoma that has completed, run by Elevar Therapeutics. The registered enrollment target is 490 participants, above the 378-participant average among 60 other Cholangiocarcinoma trials with a reported enrollment target (30% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04526106, a Phase 1 study of Cholangiocarcinoma and Intrahepatic Cholangiocarcinoma, has completed, sponsored by Elevar Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 490 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Conditions Studied
Interventions
- DRUG RLY-4008
Study Locations (20)
California
- USC Norris Comprehensive Cancer Center - Los Angeles
- UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco
Florida
- Mayo Clinic - Jacksonville
- Moffitt Cancer Center - Tampa
Texas
- Texas Oncology - Dallas
- The University of Texas M.D. Anderson Cancer Center - Houston
Other
- St. Vincent's Hosptial Sydney - Darlinghurst
- Linear Clinical Research Ltd - Nedlands
Alabama
- The University of Alabama at Birmingham - Birmingham
Arizona
- Mayo Clinic - Phoenix
Georgia
- Winship Cancer Institute, Emory University - Atlanta
Illinois
- University of Chicago Medical Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 490 participants |
| Start Date | 2020-09-02 |
| Est. Completion | 2025-09-05 |
| Phase | Phase 1 |
What the finished NCT04526106 record still lists
NCT04526106 is an interventional study that assigns participants to a tested intervention. The registered 490 participants enrollment target is mid-sized for trials with a published cap, above the 378-participant average among 60 other Cholangiocarcinoma trials with a reported enrollment target (30% higher).
The record links to 8 conditions, with Cholangiocarcinoma appearing as the primary indexed condition, and to 1 intervention - of which RLY-4008 is the first listed.
NCT04526106 names 20 study sites across 16 states, led by California, Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT04526106 about?
NCT04526106 is a clinical study titled "REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors". 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 ot...
What is the current status of trial NCT04526106?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 490 participants. The study started on 2020-09-02. Estimated completion is 2025-09-05.
What conditions does trial NCT04526106 study?
This clinical trial studies the following conditions: Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma, Other Solid Tumors, Adult, FGFR2 Gene Fusion/Rearrangement, FGFR2 Gene Mutation.
What interventions are being tested in trial NCT04526106?
The interventions under investigation include: RLY-4008 (DRUG).
Who is sponsoring clinical trial NCT04526106?
This trial is sponsored by Elevar Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04526106 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04526106's enrollment target sits among peer trials
490 10th of 60 higher than 51 of 60 other Cholangiocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cholangiocarcinoma 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.
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