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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Lirafugratinib
  Lirafugratinib is an oral inhibitor of FGFR2

Первичные конечные точки

• Objective Response Rate (ORR) assessed by Independent Review Committee per RECIST v1.1. [Срок оценки: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.]

Вторичные конечные точки (12)

• Duration of response (DOR) assessed by Independent Review Committee per RECIST v1.1. [Срок оценки: 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. [Срок оценки: Every cycle (4-week cycles) until study discontinuation, approximately 24 months.]
• Number of patients with dose interruptions. [Срок оценки: Every 28-day cycle until end of treatment, approximately 24 months.]
• Number of patients with dose reductions. [Срок оценки: Every 28-day cycle until end of treatment, approximately 24 months.]
• Number of patients with dose discontinuations. [Срок оценки: Every 28-day cycle until end of treatment, approximately 24 months.]
• Objective Response Rate (ORR) as assessed by Investigator per RECIST v1.1. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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). [Срок оценки: Up to approximately 36 months.]
• Time to response (TTR) assessed by Investigator and Independent Review Committee per RECIST v1.1. [Срок оценки: Up to approximately 36 months.]
• Time to progression (TTP) assessed by Investigator and Independent Review Committee per RECIST v1.1. [Срок оценки: Up to approximately 36 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 7 центров

• Mayo Clinic — Phoenix
• Mayo Clinic — Jacksonville
• Moffitt Cancer Center — Tampa
• University of Chicago Medical Center — Chicago
• Massachusetts General Hospital — Boston
• Mayo Clinic — Rochester
• The University of Texas M.D. Anderson Cancer Center — Houston

Франция · 4 центра

• Institut Bergonie — Bordeaux
• Centre Georges François Leclerc — Dijon
• Centre Leon Berard — Lyon
• Gustave Roussy Cancer Campus — Paris

Испания · 3 центра

• START Barcelona-Hospital HM Nou Delfos — Barcelona
• Hospital Universitario Fundación Jiménez Díaz- START MADRID — Madrid
• Hospital Universitario HM Sanchinarro-START MADRID-CIOCC — Madrid

Великобритания · 3 центра

• University College Hospital (NIHR UCLH Clinical Research Facility) — London
• Sarah Cannon Research Institute UK — London
• The Christie NHS Foundation — Manchester

South Korea · 2 центра

• Seoul National University Hospital — Seoul
• Samsung Medical Center — Seoul

Идентификаторы

NCT: NCT07359820 · ELE-4008-202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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