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Taking people in United StatesPhase 2

Tests lirafugratinib in solid tumors with an FGFR2 gene change

Tests lirafugratinib in adults with FGFR2-changed solid tumors, not bile duct cancer.

Key facts

Who runs it
Elevar Therapeutics
Where
Boston, Chicago, Houston, Jacksonville, New York, Phoenix, Rochester, and Tampa, United StatesSee the 8 sitesAlso in 4 other countries, 11 sites
Trial code
Registry title
A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement
Status
Recruiting
Phase
Phase 2
People taking part
30 people, planned
Started
4 Jun 2026
Expected to end
Dec 2028
Type of study
Interventional
Treatments tested
  • Lirafugratinib
Record updated
9 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a solid tumor that has an FGFR2 gene fusion or rearrangement. The tumor must not be cholangiocarcinoma and must already have been treated.

Age
18 years or older
Sex
All sexes can join
Disease stage
Solid tumor (not cholangiocarcinoma) that cannot be removed by surgery, is locally advanced or has spread. The disease must be measurable (RECIST v1.1). ECOG performance status 0-1.
Earlier treatment
Must have had at least 1 earlier line of systemic therapy (more than 30 days ago), such as chemotherapy, immunotherapy, radiation therapy or other approved therapies. Must not have had an FGFR inhibitor before.
Biomarker or test result
A documented FGFR2 gene fusion or rearrangement, found by local testing of blood and/or tumor.

Main reasons for not taking part

  • Uncontrolled other illness
  • Organ function that is not adequate
  • Active infection, including HIV, hepatitis B or hepatitis C (well-controlled hepatitis B can join)
  • QTcF over 480 msec or a history of prolonged QT syndrome
  • CNS metastases or a CNS tumor with worsening neurologic symptoms

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)
  • Clinically significant, uncontrolled cardiovascular disease
  • 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
  • An uncontrolled comorbidity
  • Patient does not have adequate organ function (defined in protocol)
  • CNS metastases or primary CNS tumor that is associated with progressive neurologic symptoms

Where in United States

Also in 4 other countries, 11 sites

  • Massachusetts General HospitalBoston, United StatesContact: Mass General HospitalTaking people
  • University of Chicago Medical CenterChicago, United StatesContact: General Office of Clinical ResearchTaking people
  • The University of Texas M. D. Anderson Cancer CenterHouston, United StatesContact: Jordi Rodon Ahnert, MD, PhD (principal investigator)Taking people
  • Mayo ClinicJacksonville, United StatesContact: Elevar TherapeuticsNot yet recruiting
  • Memorial Sloan-Kettering Cancer CenterNew York, United StatesContact: Memorial Sloan Kettering Cancer CenterTaking people
  • Mayo ClinicPhoenix, United StatesContact: Elevar TherapeuticsNot yet recruiting
  • Mayo ClinicRochester, United StatesContact: Elevar TherapeuticsNot yet recruiting
  • Moffitt Cancer CenterTampa, United StatesContact: Richard Kim, MD (principal investigator)Taking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

  • LirafugratinibTreatment being tested

    Treatment with standard dose of lirafugratinib

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Tests lirafugratinib in solid tumors with an FGFR2 gene changeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
9 November 2026