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    DRUG:

    TFX06

    i
    Other names: TFX06, TFX-06
    Associations

    News

    Trials
    Company:
    WuXi AppTec, Shenzhen Yangli Pharma
    Drug class:
    Selective estrogen receptor α degrader
    Related drugs:
    Associations

    News

    Trials
    2years
    TFX06, a next-generation oral CERAN/SERD, shows favorable safety and PK profile, extracranial and intracranial efficacy in patients with ER+/HER2- breast cancer: Preliminary results from a phase 1/2 first-in-human trial (SABCS 2023)
    Prior anticancer treatments included one or two lines of endocrine therapies, including fulvestrant, and/or one or two lines of chemotherapies. Based on the preliminary results, oral administration of TFX06 at 60 or 100 mg once daily had favorable safety and PK profiles. TRAEs, such as gastrointestinal toxicities, bradycardia, and visual disturbances were not observed. Pleasingly, TFX06 demonstrated early extracranial and intracranial antitumor activity (PR) in a patient with a brain metastasis.
    Clinical • P1/2 data • Tumor mutational burden
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TMB (Tumor Mutational Burden)
    |
    HER-2 negative • ER mutation • ER D538G • ESR1 mutation
    |
    fulvestrant • TFX06
    over2years
    Study of TFX06 in Women With Advanced Breast Cancer. (clinicaltrials.gov)
    P1/2, N=74, Recruiting, Shenzhen Yangli Pharmaceutical Technology Co., Ltd
    New P1/2 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • CDK4 (Cyclin-dependent kinase 4)
    |
    ER mutation • ESR1 mutation
    |
    TFX06