A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement
Phase 2 – studying effectiveness and dosage
Conditions:
FGFR2 Gene Fusion/Rearrangement
Other Solid Tumors, Adult
Sponsor: Elevar Therapeutics
trial.available_in:
БГ
Overview
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.
Who can participate
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.
Interventions
Lirafugratinib
DRUG
Locations
19
France (4)
Institut Bergonie
Bordeaux
NOT_YET_RECRUITING
Centre Georges François Leclerc
Dijon
NOT_YET_RECRUITING
Centre Leon Berard
Lyon
NOT_YET_RECRUITING
Gustave Roussy Cancer Campus
Paris
NOT_YET_RECRUITING
South Korea (2)
Seoul National University Hospital
Seoul
NOT_YET_RECRUITING
Samsung Medical Center
Seoul
NOT_YET_RECRUITING
Spain (3)
START Barcelona-Hospital HM Nou Delfos
Barcelona
NOT_YET_RECRUITING
Hospital Universitario Fundación Jiménez Díaz- START MADRID