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An Open-Label, Single-Arm, Multicenter Phase 2/3b Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HMPL-453 Tartrate in Patients With Advanced Intrahepatic Cholangiocarcinoma Habouring FGFR2 Fusion/Rearrangement

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Trial Profile

An Open-Label, Single-Arm, Multicenter Phase 2/3b Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HMPL-453 Tartrate in Patients With Advanced Intrahepatic Cholangiocarcinoma Habouring FGFR2 Fusion/Rearrangement

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 20 Jan 2026

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At a glance

  • Drugs Hmpl 453 (Primary)
  • Indications Cholangiocarcinoma
  • Focus First in man; Registrational; Therapeutic Use
  • Sponsors Hutchison MediPharma; HUTCHMED

Most Recent Events

  • 31 Dec 2025 Protocol has been amended(Phase and planned patient number).
  • 31 Dec 2025 Planned number of patients changed from 119 to 235.
  • 31 Dec 2025 Planned End Date changed from 30 Jun 2023 to 28 Feb 2030.

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