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    Association details:
    Biomarker:HER-2 expression
    Cancer:Breast Cancer
    Drug:anvatabart opadotin (JNJ-0683) (Microtubule inhibitor, HER2-targeted antibody-drug conjugate)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    New
    Source:
    Ambrx Press Release
    Title:

    FDA Grants ARX788 Fast Track Designation for HER2-positive Metastatic Breast Cancer

    Published date:
    01/04/2021
    Excerpt:
    Ambrx announced that the U.S. Food and Drug Administration (FDA) granted ARX788 Fast Track Designation as monotherapy for the treatment of advanced or metastatic HER2-positive breast cancer patients who have received one or more prior anti-HER2 based regimens in the metastatic setting.
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    ARX788 in Breast Cancer With Low Expression of HER2

    Excerpt:
    ...- Diagnosed as HR arbitrary/HER2 low expression unresectable and/or metastatic breast cancer....
    Trial ID:
    NCT05018676
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrialsregister.eu
    Title:

    A clinical research study to test different doses of a study drug (ARX788), to see which dose is safest and its effectiveness(shrinks tumor size) in patients with advanced cancer. Estudio de investigación clínica para probar diferentes dosis del fármaco del estudio (ARX788), para ver qué dosis es la más segura y su efectividad (redución tamaño del tumor) en pacientes con cáncer avanzado.

    Excerpt:
    ...Central laboratory-confirmed HER2-positive expression (estrogen receptor/progesterone receptor positive subjects may be enrolled if they are HER2-positive) according to 2018 American Society of Clinical Oncology – College of American Pathologists (ASCO-CAP) guidelines. ...
    Trial ID:
    2021-001246-36
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Ambrx Press Release
    Title:

    Ambrx Presents Phase 1 Trial Data Update and Phase 2/3 Clinical Trial in Progress for Lead Program ARX788 at the 2020 San Antonio Breast Cancer Symposium

    Published date:
    12/10/2020
    Excerpt:
    ARX788 Phase 1 studies demonstrated promising antitumor activity in heavily pre-treated cancer patients...ORR of 74% (14/19) and DCR of 100% in the 1.5 mg/kg cohort of the Phase 1 HER2-positive breast cancer trial in China...ORR of 67% (2/3) and DCR of 100% in the 1.5 mg/kg cohort of Phase 1 HER2-positive pan tumor trial in U.S. and Australia...
    Evidence Level:
    Sensitive: D – Preclinical
    Source:
    Mol Cancer Ther
    Title:

    Nonclinical Development of Next Generation Site-Specific HER2 Targeting Antibody Drug Conjugate (ARX788) for Breast Cancer Treatment

    Published date:
    06/04/2020
    Excerpt:
    ARX788 exhibits significant, dose-dependent anti-tumor activity against HER2 expressing breast and gastric xenograft tumors.
    DOI:
    10.1158/1535-7163.MCT-19-0692