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    DRUG:

    zanidatamab zovodotin (ZW49)

    i
    Other names: ZW 49, ZW49, ZW-49, ADC ZW49, zani zo
    Company:
    BeOne Medicines, Zymeworks
    Drug class:
    Microtubule inhibitor, HER2-targeted antibody-drug conjugate
    Related drugs:
    10d
    Recent advances in bispecific antibody-drug conjugates for breast cancer therapy. (PubMed, Cancer Chemother Pharmacol)
    BsADCs are a transformative therapeutic modality for breast cancer. Their ability to enhance tumor selectivity, overcome heterogeneity, and target resistant pathways positions them as key players in the future oncology landscape, with ongoing trials poised to define their clinical role.
    Review • Journal
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    HER-2 expression
    |
    zanidatamab zovodotin (ZW49) • izalontamab brengitecan (BL-B01D1) • anbenitamab repodatecan (JSKN003)
    1year
    A Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers (clinicaltrials.gov)
    P1, N=112, Completed, Zymeworks BC Inc. | N=174 --> 112 | Trial completion date: Aug 2025 --> Oct 2024 | Trial primary completion date: Aug 2025 --> Sep 2024 | Active, not recruiting --> Completed
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    zanidatamab zovodotin (ZW49)
    2years
    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)
    over2years
    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)
    almost3years
    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
    |
    Ziihera (zanidatamab-hrii) • zanidatamab zovodotin (ZW49)
    over4years
    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)
    6years
    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)