^
    10ms
    Phase 2 Study of HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma (clinicaltrials.gov)
    P2, N=128, Recruiting, Hutchmed | Not yet recruiting --> Recruiting | N=29 --> 128 | Trial completion date: Jun 2023 --> Dec 2025 | Trial primary completion date: Dec 2022 --> Jun 2025
    Enrollment open • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    FGFR2 (Fibroblast growth factor receptor 2)
    |
    FGFR2 fusion
    |
    HMPL-453
    10ms
    HMPL-453 Food Effect and PPI Study in Healthy Volunteer Study (clinicaltrials.gov)
    P1, N=24, Active, not recruiting, Hutchmed
    New P1 trial
    |
    HMPL-453
    1year
    A phase 2 study of HMPL-453, a selective FGFR tyrosine kinase inhibitor (TKI), in patients with previously treated advanced cholangiocarcinoma containing FGFR2 fusions. (ASCO 2023)
    All pts had received ≥1 prior treatment line and 21 (84%) had received previous gemcitabine-based chemotherapy. HMPL-453 showed promising efficacy, particularly in RP2D regimen (300 mg, QD, 2w on/1w off) and acceptable toxicity in pts with previously-treated advanced iCCA and FGFR fusions. These results warrant further study in pts with advanced iCCA. Clinical trial information: NCT04353375.
    Clinical • P2 data • Metastases
    |
    FGFR2 (Fibroblast growth factor receptor 2) • FGFR1 (Fibroblast growth factor receptor 1)
    |
    FGFR2 fusion • FGFR fusion
    |
    gemcitabine • HMPL-453
    2years
    HMPL-453 (FGFR Inhibitor) in Combination With Chemotherapy or Anti-PD-1 Antibody in Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=141, Recruiting, Hutchison Medipharma Limited | Not yet recruiting --> Recruiting | Trial primary completion date: Mar 2024 --> Sep 2024
    Enrollment open • Trial primary completion date • Combination therapy • IO biomarker
    |
    FGFR (Fibroblast Growth Factor Receptor)
    |
    cisplatin • gemcitabine • docetaxel • Loqtorzi (toripalimab-tpzi) • HMPL-453
    over2years
    HMPL-453 (FGFR Inhibitor) in Combination With Chemotherapy or Anti-PD-1 Antibody in Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=141, Not yet recruiting, Hutchison Medipharma Limited
    New P1/2 trial • Combination therapy • IO biomarker
    |
    FGFR (Fibroblast Growth Factor Receptor)
    |
    PD-L1 expression • FGFR2 mutation • FGFR2 fusion • FGFR2 amplification • FGFR3 mutation • FGFR2 overexpression • FGFR2 expression • FGFR2 translocation
    |
    cisplatin • gemcitabine • docetaxel • Loqtorzi (toripalimab-tpzi) • HMPL-453
    almost4years
    HMPL-453 in Advanced Malignant Mesothelioma (clinicaltrials.gov)
    P2, N=27, Recruiting, Hutchison Medipharma Limited | Not yet recruiting --> Recruiting | Initiation date: Mar 2020 --> Dec 2019
    Clinical • Enrollment open • Trial initiation date
    |
    FGFR (Fibroblast Growth Factor Receptor)
    |
    HMPL-453