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    1year
    A phase Ia/Ib study of novel anti-ErbB3 monoclonal antibody, barecetamab (ISU104) in refractory solid cancers and monotherapy or in combination with cetuximab in recurrent or metastatic head and neck cancer. (PubMed, Int J Cancer)
    The recommended phase II dose was determined to be 20 mg/kg triweekly. Barecetamab and in cetuximab combination was well tolerated and demonstrated meaningful antitumor effects.
    P1 data • Clinical Trial,Phase I • Journal • Combination therapy • Metastases
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    ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
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    Erbitux (cetuximab) • barecetamab (ISU104)
    over3years
    [VIRTUAL] Final results and biomarker analysis from a phase I dose-expansion (part II) study of ISU104 (barecetamab; a novel anti-ErbB3) monotherapy or in combination with cetuximab (CET), in patients (pts) with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) (ESMO 2021)
    ISU104 alone or in combination with CET were safe and tolerable in R/M HNSCC pts. Encouraging clinical efficacies and potential biomarkers were demonstrated from combination therapy. A phase II study of ISU104 (Q3W, 20 mg/kg/day) in combination with CET (Q1W) is planned to further strengthen the clinical utility of ISU104.
    Clinical • P1 data • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • TP53 (Tumor protein P53) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
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    TP53 mutation • EGFR mutation • EGFR amplification
    |
    Erbitux (cetuximab) • barecetamab (ISU104)
    over4years
    [VIRTUAL] Phase I dose-expansion (part II) study of ISU104 (a novel anti-ErbB3 monoclonal antibody) alone and combination with cetuximab (CET), in patients (pts) with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) (ESMO 2020)
    Legal entity responsible for the study: ISU Abxis Co., Ltd. Funding: Korea Drug Development Fund.
    Clinical • P1 data
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • NRG1 (Neuregulin 1)
    |
    Erbitux (cetuximab) • barecetamab (ISU104)
    over4years
    [VIRTUAL] Anti-cancer efficacy of an anti-ErbB3 antibody, ISU104, against the cancers with NRG1-overexpression, NRG1-fusion, or oncogenic ErbB3 mutations (AACR-II 2020)
    Potential impacts of other genetic alterations on the anti-cancer efficacy of ISU104 were also investigated. Overall, the presented data suggest that ISU104, an anti-ErbB3 agent in the early stage of clinical development, can be applied for the treatment of the solid tumors expressing high level of NRG1 or harboring genetic alterations such as NRG1-fusion or oncogenic ErbB3 mutations.
    Clinical
    |
    HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • NRG1 (Neuregulin 1)
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    NRG1 fusion • ERBB3 mutation • NRG1 overexpression
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    barecetamab (ISU104)