NCT04526106

REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors

A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 490 (actual)
• Sponsor: Elevar Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• FGFR2 Amplification
• FGFR2 Gene Mutation
• FGFR2 Gene Fusion/Rearrangement
• FGFR2 Gene Translocation
• FGFR2 Gene Activation
• Intrahepatic Cholangiocarcinoma
• Cholangiocarcinoma
• Other Solid Tumors, Adult

Interventions

Type	Name	Description
DRUG	RLY-4008	RLY-4008 is an oral inhibitor of FGFR2

Timeline

• Start date: 2020-09-02
• Primary completion: 2025-09-05
• Completion: 2025-09-05
• First posted: 2020-08-25
• Last updated: 2026-02-27

Locations

48 sites across 13 countries: United States, Australia, France, Germany, Hong Kong, Italy, Netherlands, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study