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

NCT07359820 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ELE-4008-202
• Study Type: interventional
• Target: 30
• Locations: 5 countries
• Sites: 19

Brief Summary

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.

Conditions

FGFR2 Gene Fusion/Rearrangement; Other Solid Tumors, Adult

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• 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.

Study Arms (1)

Lirafugratinib

EXPERIMENTAL

Treatment with standard dose of lirafugratinib

Drug: Lirafugratinib

Interventions

Lirafugratinib DRUG

Lirafugratinib is an oral inhibitor of FGFR2

Also known as: RLY-4008

Lirafugratinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elevar Therapeutics: lead

Study Sites (19)

Mayo Clinic

Phoenix, Arizona, 85054, United States

NOT YET RECRUITING

Mayo Clinic

Jacksonville, Florida, 32224, United States

NOT YET RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

NOT YET RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

NOT YET RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

NOT YET RECRUITING

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Institut Bergonie

Bordeaux, 33076, France

NOT YET RECRUITING

Centre Georges François Leclerc

Dijon, 21079, France

NOT YET RECRUITING

Centre Leon Berard

Lyon, 69373, France

NOT YET RECRUITING

Gustave Roussy Cancer Campus

Paris, 94805, France

NOT YET RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

START Barcelona-Hospital HM Nou Delfos

Barcelona, 08023, Spain

NOT YET RECRUITING

Hospital Universitario Fundación Jiménez Díaz- START MADRID

Madrid, 28040, Spain

NOT YET RECRUITING

Hospital Universitario HM Sanchinarro-START MADRID-CIOCC

Madrid, 28050, Spain

NOT YET RECRUITING

University College Hospital (NIHR UCLH Clinical Research Facility)

London, NW1 2BU, United Kingdom

NOT YET RECRUITING

Sarah Cannon Research Institute UK

London, W1G 6AD, United Kingdom

NOT YET RECRUITING

The Christie NHS Foundation

Manchester, M20 4GJ, United Kingdom

NOT YET RECRUITING

Central Study Contacts

Jacki Dillingham

CONTACT

+1 (385) 276-3611; jdillingham@elevartx.com

Lissa Nazal

CONTACT

+1 (385) 276-3621; lnazal@elevartx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3); KR (2); ES (3); FR (4); US (7)