Clinical Trial 24023

• Overview

  Study 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

  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.

  Objective:

  Primary Objective * To evaluate the efficacy of lirafugratinib by ORR assessed by IRC. Secondary Objectives * To determine the DOR of lirafugratinib assessed by IRC. * To evaluate the safety and tolerability of lirafugratinib. * To evaluate the additional antitumor activity of lirafugratinib. * To evaluate the PK of lirafugratinib. * To evaluate the ER of lirafugratinib for efficacy and safety. * To evaluate the QoL.

• Treatments

  Therapies:

  FGFR2 Inhibitor

  Medications:

  Lirafugratinib ()

• Inclusion Criteria

  Key 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

  Key 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.

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