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    DRUG:

    clifutinib (HEC73543)

    i
    Other names: HEC73543, HEC 73543
    Company:
    HEC Pharm
    Drug class:
    FLT3 inhibitor
    Related drugs:
    2ms
    Clinical Study on the Mass Balance of Clifutinib (clinicaltrials.gov)
    P1, N=6, Not yet recruiting, Sunshine Lake Pharma Co., Ltd.
    New P1 trial
    |
    clifutinib (HEC73543)
    8ms
    A Phase Ⅰb/Ⅱ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML (clinicaltrials.gov)
    P1/2, N=133, Recruiting, Sunshine Lake Pharma Co., Ltd. | Not yet recruiting --> Recruiting | Trial primary completion date: Feb 2025 --> May 2026
    Enrollment open • Trial primary completion date
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    FLT3-ITD mutation
    |
    cytarabine • azacitidine • clifutinib (HEC73543)
    8ms
    Discovery of FLT3-ITD Inhibitor Clifutinib: A Novel Biphenylacetylene Urea Derivative in Clinical Trials for the Treatment of Relapsed/Refractory FLT3-ITD+ Acute Myeloid Leukemia. (PubMed, J Med Chem)
    Moreover, compound 9e displayed favorable drug-like properties and significantly suppressed tumor growth in MV-4-11 (1.5 mg/kg, qd, tumor growth inhibition (TGI) = 193.5%) and MOLM-13 (4.5 mg/kg, qd, TGI = 94%) xenograft tumor models in mice without significant weight loss. Compound 9e (named Clifutinib) is currently being evaluated in a phase III clinical trial (NCT05586074) for the treatment of relapsed/refractory FLT3-ITD-positive AML.
    Journal
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    FLT3-ITD mutation • FLT3 mutation
    |
    clifutinib (HEC73543)
    8ms
    HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML (clinicaltrials.gov)
    P3, N=324, Recruiting, Sunshine Lake Pharma Co., Ltd. | Trial completion date: May 2026 --> Jun 2027
    Trial completion date
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    FLT3 mutation
    |
    cytarabine • azacitidine • decitabine • idarubicin hydrochloride • fludarabine IV • clifutinib (HEC73543)
    1year
    A Clinical Trial to Evaluate Clifutinib in Patients with Relapsed or Refractory Acute Myeloid Leukemia(AML) (clinicaltrials.gov)
    P1, N=75, Completed, Sunshine Lake Pharma Co., Ltd. | Recruiting --> Completed
    Trial completion
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    FLT3-ITD mutation
    |
    clifutinib (HEC73543)
    2years
    Efficacy and Safety of Clifutinib, a Novel, Highly Selective, Oral FLT3 Inhibitor, in Patients with FLT3-Mutated Relapsed or Refractory Acute Myeloid Leukemia:Updated Results from a Phase I Study (ASH 2023)
    This phase 1 study has demonstrated an acceptable safety profile and a significant anti-leukaemic activity of clifutinib in FLT3 mutant R/R AML, with the best response at the dose of 40 mg/day in FLT3-ITD(+)/TKD(-) AML. A confirmatory phase 3 study is currently ongoing to further evaluate the efficacy and safety of clifutinib dosed at 40 mg/day in R/R AML pts after first-line therapy with FLT3-ITD(+)/TKD(-) (NCT05586074).
    Clinical • P1 data
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    FLT3 mutation • FLT3 positive
    |
    clifutinib (HEC73543)
    over2years
    HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML (clinicaltrials.gov)
    P3, N=324, Recruiting, Sunshine Lake Pharma Co., Ltd. | Not yet recruiting --> Recruiting | Initiation date: Nov 2022 --> Mar 2023
    Enrollment open • Trial initiation date
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    FLT3 mutation
    |
    cytarabine • azacitidine • decitabine • idarubicin hydrochloride • fludarabine IV • clifutinib (HEC73543)
    3years
    HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML (clinicaltrials.gov)
    P3, N=324, Not yet recruiting, Sunshine Lake Pharma Co., Ltd.
    New P3 trial
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    FLT3 mutation
    |
    cytarabine • azacitidine • decitabine • idarubicin hydrochloride • fludarabine IV • clifutinib (HEC73543)
    over3years
    A Clinical Trial to Evaluate Clifutinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia(AML) (clinicaltrials.gov)
    P1, N=80, Recruiting, Sunshine Lake Pharma Co., Ltd. | Trial completion date: Dec 2022 --> Mar 2023 | Trial primary completion date: Jun 2022 --> Dec 2022
    Trial completion date • Trial primary completion date
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    FLT3-ITD mutation
    |
    clifutinib (HEC73543)
    over3years
    PRELIMINARY RESULTS OF A PHASE I STUDY OF CLIFUTINIB, A HIGHLY SELECTIVE, POTENT ORAL FLT-3 INHIBITOR, IN PATINETS WITH FLT3-MUTATED RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (EHA 2022)
    Conclusion Preliminary results of this phase 1 study demonstrated that Clifutinib has an acceptable safety profile and promising antitumor activity, especially at the dose of 40 mg daily. A confirmatory phase 3 study is planned to further evaluate the efficacy and safety of Clifutinib at 40 mg daily in FLT3-mutated R/R AML.
    P1 data
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    FLT3-ITD mutation • FLT3 mutation
    |
    clifutinib (HEC73543)
    over3years
    A Clinical Trial to Evaluate Clifutinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia(AML) (clinicaltrials.gov)
    P1, N=80, Recruiting, Sunshine Lake Pharma Co., Ltd. | Trial completion date: Apr 2022 --> Dec 2022 | Trial primary completion date: Oct 2021 --> Jun 2022
    Trial completion date • Trial primary completion date
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    FLT3-ITD mutation
    |
    clifutinib (HEC73543)
    over3years
    A Phase Ⅰb/Ⅱ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML (clinicaltrials.gov)
    P1/2, N=133, Not yet recruiting, Sunshine Lake Pharma Co., Ltd. | Trial completion date: Oct 2024 --> Oct 2026 | Initiation date: Jan 2022 --> Oct 2022 | Trial primary completion date: Jul 2023 --> Feb 2025
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    FLT3-ITD mutation
    |
    cytarabine • azacitidine • clifutinib (HEC73543)