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    Association details:
    Biomarker:HER-2 overexpression
    Cancer:Solid Tumor
    Drug:trastuzumab mafodotin (IKS014) (Microtubule inhibitor, HER2-targeted antibody-drug conjugate)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Phase 1 Study of FS-1502 in Patients With HER2 Expressed Advanced Solid Tumors and Breast Cancer.

    Excerpt:
    ...HER2 overexpression: IHC3+, IHC2+/FISH+, or FISH+ 2....
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    SABCS 2022
    Title:

    FS-1502, an anti-HER2 ADC, in Patients with HER2-Expressing Advanced Solid Tumors: A Phase 1a Dose-Escalation Study

    Published date:
    11/22/2022
    Excerpt:
    Patients with HER2-expresssing advanced solid tumors who had failed prior standard of care therapies were enrolled...ORRs were observed at doses at or above 1.0 mg/kg with an ORR of 66.7% (4/6) at the recommended phase 2 dose (RP2D) of 2.3 mg/kg. Median duration of response (DoR) across all dose levels was 9.2 months (95%CI 5.6-NR)...FS-1502 was well-tolerated and demonstrated encouraging antitumor activity in both HER2-high and -low patients.
    Trial ID:
    FS-CY1502-Ph1-01