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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 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.

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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

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

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

FieldValue
Enrollment Target 490 participants
Start Date 2020-09-02
Est. Completion 2025-09-05
Phase Phase 1

Sponsor

Elevar Therapeutics

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04526106

The ClinicalTrials.gov registry entry for NCT04526106 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 490 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 378-participant average among 60 other Cholangiocarcinoma trials with a reported enrollment target (30% higher). The listed sponsor is Elevar Therapeutics, which has 8 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 16 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.