Futibatinib For Advanced Cholangiocarcinoma with FGFR2

In Patient Speak

The FGFR2 gene in Cell City’s Town Hall (nucleus) has been damaged and is in overdrive, frantically sending out mRNA messages to produce an excessive number of FGFR2 growth receptors—like rogue satellite receivers—on the cell surface. With too many satellites tuned into nonstop growth signals, the city spirals into chaos with uncontrolled expansion.

Scientists developed Futibatinib as a specialised blocker to target these rogue FGFR2 satellite dishes, jamming their ability to receive harmful growth signals. By silencing this overload, Futibatinib restores stability and order to Cell City.

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TAS-120: Futibatinib in Advanced Cholangiocarcinoma with FGFR2 Fusions

Study Overview: Futibatinib in Advanced Cholangiocarcinoma

Study Type:
Open-label, multinational, randomized Phase 2 study

Objective:
To confirm the clinical benefit of 20 mg futibatinib and evaluate the safety and efficacy of 16 mg futibatinib in patients with advanced cholangiocarcinoma (CCA) harbouring FGFR2 gene fusions and other rearrangements.

Study Design

  • Randomisation:
    Eligible patients will be randomised 1:1 into two treatment arms.
  • Treatment Arms:
    • Arm 1:
      Futibatinib at an oral dose of 16 mg, administered daily (QD) on every day of a 21-day cycle.
    • Arm 2:
      Futibatinib at an oral dose of 20 mg, administered daily (QD) on every day of a 21-day cycle.
  • Treatment Duration:
    Patients will continue receiving futibatinib until:

    • Documentation of progressive disease (PD) as per RECIST 1.1, or
    • Other withdrawal criteria are met.

Study Locations

New South Wales

  • Sydney, NSW, Australia, 2010 – Recruiting
    • St Vincent’s Hospital Sydney – The Kinghorn Cancer Centre
    • Principal Investigator: Hao-Wen Sim

Victoria

  • Melbourne, VIC, Australia, 3004 – Recruiting
    • Alfred Health, Medical Oncology Unit, Second Floor, William Buckland Radiotherapy Center
    • Principal Investigator: Sanjeev Gill

Western Australia

  • Subiaco, WA, Australia, 6008 – Not Yet Recruiting
    • St John of God Subiaco Hospital

Official Study Title

Phase 2 Study of Futibatinib 20 mg and 16 mg in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusions or Rearrangements

Key Conditions Studied

  • Advanced Cholangiocarcinoma
  • FGFR2 Fusions
  • Gene Rearrangements

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