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    DRUG:

    ALT02 (trastuzumab biosimilar)

    i
    Other names: ALT02, ALT-L2, ALT L2, QL-1701
    Associations

    News

    Trials
    Company:
    Alteogen, Cristalia, Qilu Pharma
    Drug class:
    HER2 inhibitor
    Related drugs:
    Associations

    News

    Trials
    16d
    A Multicenter, Double-blind, Randomized, Parallel-group, Phase III Study of the Efficacy and Safety of QL1701 Plus Docetaxel Versus Herceptin® Plus Docetaxel as First Line Therapy in Patients With HER2-positive Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=474, Completed, Qilu Pharmaceutical Co., Ltd. | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Herceptin (trastuzumab) • docetaxel • ALT02 (trastuzumab biosimilar)
    1year
    A Multicenter, Double-blind, Randomized, Parallel-group, Phase III Study of the Efficacy and Safety of QL1701 Plus Docetaxel Versus Herceptin® Plus Docetaxel as First Line Therapy in Patients With HER2-positive Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=474, Active, not recruiting, Qilu Pharmaceutical Co., Ltd. | Trial completion date: Apr 2023 --> Oct 2023 | Trial primary completion date: Aug 2022 --> Dec 2022
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Herceptin (trastuzumab) • docetaxel • ALT02 (trastuzumab biosimilar)
    over1year
    A Multicenter, Double-blind, Randomized, Parallel-group, Phase III Study of the Efficacy and Safety of QL1701 Plus Docetaxel Versus Herceptin® Plus Docetaxel as First Line Therapy in Patients With HER2-positive Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=474, Active, not recruiting, Qilu Pharmaceutical Co., Ltd.
    New P3 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Herceptin (trastuzumab) • docetaxel • ALT02 (trastuzumab biosimilar)
    4years
    [VIRTUAL] First-in-human phase I study of ALT-P7, a HER2-targeting antibody-drug conjugate in patients with HER2-positive advanced breast cancer. (ASCO 2020)
    Background: ALT-P7 is an antibody-drug conjugate, in which two molecules of monomethyl auristatin E (MMAE) are site-specifically conjugated to a cysteine-containing peptide motif of trastuzumab variant... ALT-P7 was well tolerated to a dose of 4.2mg/kg in heavily pretreated HER2-positive advanced breast cancer. DLTs were observed at 4.8mg/kg, and 4.5mg/kg is under evaluation. The observed clinical activity warrants further evaluation in a phase 2 trial.
    Clinical • P1 data
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • ALT-P7 • ALT02 (trastuzumab biosimilar)