A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement (ReFocus202)

A Phase 2, Open-Label, Single-Arm Study of Lirafugratinib in Patients With Previously Treated, Unresectable, Locally Advanced or Metastatic Solid Tumors (Excluding Cholangiocarcinoma) With FGFR2 Fusion or Rearrangement

The goal of this clinical trial is to evaluate if lirafugratinib is efficacious and safe to treat adult patients with previously treated, unresectable, locally advanced or metastatic solid tumors (excluding cholangiocarcinoma) harboring FGFR2 fusion or rearrangement.

Participants will:

• Take lirafugratinib regularly as instructed by their study doctor.
• Visit the clinic as instructed for checkups and tests.
• Keep a diary recording each time a dose of lirafugratinib is taken.

Study Overview

• Status: Recruiting
• Conditions: FGFR2 Gene Fusion/Rearrangement; Other Solid Tumors, Adult
• Intervention / Treatment: Drug: Lirafugratinib

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jacki Dillingham; Phone Number: +1 (385) 276-3611; Email: jdillingham@elevartx.com
• Study Contact Backup: Name: Lissa Nazal; Phone Number: +1 (385) 276-3621; Email: lnazal@elevartx.com

Study Locations

• France
  • Bordeaux, France, 33076
    • Not yet recruiting
    • Institut Bergonie
  • Dijon, France, 21079
    • Not yet recruiting
    • Centre Georges Francois Leclerc
  • Lyon, France, 69373
    • Not yet recruiting
    • Centre Leon Berard
  • Paris, France, 94805
    • Not yet recruiting
    • Gustave Roussy Cancer Campus
• South Korea
  • Seoul, South Korea, 03080
    • Recruiting
    • Seoul National University Hospital
  • Seoul, South Korea, 06351
    • Recruiting
    • Samsung Medical Center
• Spain
  • Barcelona, Spain, 08023
    • Not yet recruiting
    • START Barcelona-Hospital HM Nou Delfos
  • Madrid, Spain, 28040
    • Not yet recruiting
    • Hospital Universitario Fundación Jiménez Díaz- START MADRID
  • Madrid, Spain, 28050
    • Not yet recruiting
    • Hospital Universitario HM Sanchinarro-START MADRID-CIOCC
• United Kingdom
  • London, United Kingdom, W1G 6AD
    • Not yet recruiting
    • Sarah Cannon Research Institute UK
  • London, United Kingdom, NW1 2BU
    • Not yet recruiting
    • University College Hospital (NIHR UCLH Clinical Research Facility)
  • Manchester, United Kingdom, M20 4GJ
    • Not yet recruiting
    • The Christie NHS Foundation
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Not yet recruiting
      • Mayo Clinic
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Not yet recruiting
      • Mayo Clinic
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
      • Principal Investigator: Richard Kim, MD
      • Contact: Moffitt Clinical Trials Information; Phone Number: 1-855-470-6706
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Not yet recruiting
      • University of Chicago Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Not yet recruiting
      • Massachusetts General Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Not yet recruiting
      • Mayo Clinic
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas M.D. Anderson Cancer Center
      • Principal Investigator: Jordi Rodon Ahnert, MD, PhD
      • Contact: UT M.D. Anderson Cancer Center Clinical Trial Information; Phone Number: 1-877-632-6789

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Unresectable, locally advanced, or metastatic solid tumor (other than CCA).
• Documented FGFR2 gene fusion or rearrangement per local testing of blood and/or tumor.
• Patient must have measurable disease per RECIST v1.1• Patient has ECOG performance status of 0-1.
• Previously (>30 days) treated with ≥1 line of systemic therapy including chemotherapy (e.g., gemcitabine/cisplatin), immunotherapy, radiation therapy, or other approved therapies.
• Subject has not received prior treatment with an FGFRi.

Exclusion Criteria:

• An uncontrolled comorbidity.
• Patient does not have adequate organ function (defined in protocol).
• Patient has active infection, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV) (defined in protocol). Patients with well-controlled HBV are eligible (defined in protocol).
• QT interval corrected using Fridericia's formula (QTcF) > 480 msec or history of prolonged QT syndrome, Torsades de pointes or familial history of prolonged QT syndrome.
• Clinically significant, uncontrolled cardiovascular disease.
• CNS metastases or primary CNS tumor that is associated with progressive neurologic symptoms.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lirafugratinib; Treatment with standard dose of lirafugratinib	Drug: Lirafugratinib; Lirafugratinib is an oral inhibitor of FGFR2; Other Names: RLY-4008

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate (ORR) assessed by Independent Review Committee per RECIST v1.1.	Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacodynamic parameters including changes in carcinoembryonic antigen (CEA)		Approximately every 2 weeks in Cycle 1 (4-week cycle) and every other cycle (4-week cycles) from Cycle 3, approximately 24 months
Pharmacodynamic parameters including changes in cancer antigen 19-9 (CA 19-9)		Approximately every 2 weeks in Cycle 1 (4-week cycle) and every other cycle (4-week cycles) from Cycle 3, approximately 24 months
Pharmacokinetic parameters including area under the plasma concentration versus time curve (AUC)		Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through Cycle 4 (4-week cycles)
Pharmacokinetic parameters including half-life (t1/2)		Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through Cycle 4 (4-week cycles)
Duration of response (DOR) assessed by Independent Review Committee per RECIST v1.1.		Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.
Number of patients with adverse events and serious adverse events.		Every cycle (4-week cycles) until study discontinuation, approximately 24 months.
Number of patients with dose interruptions.		Every 28-day cycle until end of treatment, approximately 24 months.
Number of patients with dose reductions.		Every 28-day cycle until end of treatment, approximately 24 months.
Number of patients with dose discontinuations.		Every 28-day cycle until end of treatment, approximately 24 months.
Objective Response Rate (ORR) as assessed by Investigator per RECIST v1.1.		Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.
Duration of Response (DOR) as assessed by Investigator per RECIST v1.1.		Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months
Disease control rate (DCR) as assessed by Investigator and Independent Review Committee per RECIST v1.1.		Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.
Progression-free survival (PFS) as assessed by Investigator and Independent Review Committee per RECIST v1.1.		Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months
Overall survival (OS).		Up to approximately 36 months.
Time to response (TTR) assessed by Investigator and Independent Review Committee per RECIST v1.1.		Up to approximately 36 months.
Time to progression (TTP) assessed by Investigator and Independent Review Committee per RECIST v1.1.		Up to approximately 36 months
Pharmacokinetic parameters including maximum plasma drug concentration (Cmax)		[Time Frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through Cycle 4 (4-week cycles)]
Change from baseline in quality of life as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).	It scores (0-100) where higher means better function/quality of life in that section of the questionnaire and higher means worse symptoms in that section of the questionnaire.	Approximately every 4 weeks during treatment, approximately 24 months
Time to deterioration (TTD).		Up to approximately 36 months.
FGFR2 gene status in plasma circulating tumor deoxyribonucleic acid (ctDNA) and tumor tissue.		Every cycle (4-week cycles) through Cycle 3 and every other cycle thereafter until study discontinuation, approximately 24 months.
Pharmacodynamic parameters including changes in fibroblast growth factor 23 (FGF-23).		Approximately every 2 weeks in Cycle 1 (4-week cycle) and every other cycle (4-week cycles) from Cycle 3, approximately 24 months.
Correlation between FGFR2 genotype by central tissue assessment and antitumor response, as measured by Objective Response Rate (ORR).		Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.

Collaborators and Investigators

• Sponsor: Elevar Therapeutics

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: January 16, 2026
• First Submitted That Met QC Criteria: January 21, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ELE-4008-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No