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

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Trial Profile

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

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

Latest Information Update: 07 Mar 2025

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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

    • 06 Mar 2025 According to a HUTCHMED media release, the company expects to announce topline results from the study around the end of 2025. If favorable, the results could enable a New Drug Application submission to China's National Medical Products Administration (NMPA).
    • 06 Mar 2025 Status changed from recruiting to active, no longer recruiting.
    • 06 Jun 2023 Results (At data cutoff: 21 Sep 2022; n=25) presented at the 59th Annual Meeting of the American Society of Clinical Oncology.

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