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

NCT04526106 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 490

Last updated 2026-02-27

No results posted yet for this 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

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

Interventions

DRUG

RLY-4008

RLY-4008 is an oral inhibitor of FGFR2

Sponsors & Collaborators

  • Elevar Therapeutics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-02
Primary Completion
2025-09-05
Completion
2025-09-05
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Germany
  • Hong Kong
  • Italy
  • Netherlands
  • Singapore
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04526106 on ClinicalTrials.gov