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    DRUG:

    zanidatamab zovodotin (ZW49)

    i
    Other names: ZW49, ZW-49, ADC ZW49, zani zo
    Company:
    BeiGene, Zymeworks
    Drug class:
    Microtubule inhibitor, HER2-targeted antibody-drug conjugate
    Related drugs:
    5ms
    A Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers (clinicaltrials.gov)
    P1, N=174, Active, not recruiting, Zymeworks Inc. | Trial primary completion date: Aug 2023 --> Aug 2025
    Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    zanidatamab zovodotin (ZW49)
    8ms
    Phase 1 Study of Zanidatamab Zovodotin (ZW49): Safety Profile and Recommended Dose (RD) in Patients with Human Epidermal Growth Factor2 (HER2)-positive Solid Cancers. (AACR-NCI-EORTC 2023)
    No abstract available
    Clinical • P1 data
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    zanidatamab (ZW25) • zanidatamab zovodotin (ZW49)
    1year
    A Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers (clinicaltrials.gov)
    P1, N=174, Active, not recruiting, Zymeworks Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    zanidatamab zovodotin (ZW49)
    1year
    Zanidatamab zovodotin (ZW49) induces hallmarks of immunogenic cell death and is active in patient-derived xenograft models of gastric cancer (AACR 2023)
    Anti-tumor activity was observed in 5/7 (71%) PDX models of gastric cancer after a single i.v. dose of 6 mg/kg, including in models with moderate and weak HER2 expression. The strong anti-tumor activity of ZW-49 in vivo, together with its ability to induce ICD and potential adaptive immune responses, support ZW49 as a promising ADC for the treatment of HER2-expressing cancers warranting further investigation, including potential combination with checkpoint inhibitors.
    Preclinical
    |
    HMGB1 (High Mobility Group Box 1) • CALR (Calreticulin)
    |
    HER-2 positive • HER-2 negative • HER-2 expression
    |
    zanidatamab (ZW25) • zanidatamab zovodotin (ZW49)
    almost3years
    A Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers (clinicaltrials.gov)
    P1, N=174, Recruiting, Zymeworks Inc. | Trial completion date: Apr 2023 --> Aug 2025 | Trial primary completion date: May 2021 --> Aug 2023
    Clinical • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression • HER-2-H
    |
    zanidatamab zovodotin (ZW49)
    over4years
    A Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers (clinicaltrials.gov)
    P1, N=150, Recruiting, Zymeworks Inc. | N=69 --> 150
    Clinical • Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression • HER-2-H
    |
    zanidatamab zovodotin (ZW49)