clinical trial · NCT04526106
REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors
FGFR2 AmplificationFGFR2 Gene MutationFGFR2 Gene Fusion/RearrangementFGFR2 Gene TranslocationFGFR2 Gene ActivationIntrahepatic CholangiocarcinomaCholangiocarcinomaOther Solid Tumors, AdultRLY-4008
brief 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).
started
Sep 2, 2020
primary completion
Sep 5, 2025
completion
Sep 5, 2025
last updated
Feb 27, 2026
official title
A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol