Tests lirafugratinib in solid tumors with an FGFR2 gene change
Tests lirafugratinib in adults with FGFR2-changed solid tumors, not bile duct cancer.
Plain-language title generated from the registry record
Registry title: A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement
Key facts
- Where
- Barcelona and Madrid, SpainSee the 3 sites
- Phase
- Phase 2
Where in Spain
- START Barcelona Hospital HM Nou DelfosBarcelona, SpainTaking people
- Hospital Universitario Fundación Jiménez Díaz- START MADRIDMadrid, SpainTaking people
- Hospital Universitario HM Sanchinarro - START Madrid CIOCCMadrid, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Elevar Therapeutics
- Trial code
- NCT07359820
- Record updated
- 9 November 2026
- Original description
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
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.
Inclusion: 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: 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.