Study of MT-5111 in HER2-positive Solid Tumors (MT-5111)

A Phase 1b Open-label, Multicenter Dose Escalation and Expansion Study of MT-5111 in Subjects With Previously Treated Advanced HER2-positive Solid Tumors

  • Clinical Trial Information

    Trial Contact: Donaldson, Karin M; Grofsik, Kiera; Frankos, Marie

  • IRB No: WIRB:20191701

    Protocol Abbrev: MT-5111

    Principal Investigator: Sajeve Samuel Thomas, MD

    Phase: Drug: Phase I

    Age Group: Adult

    Secondary Protocol No: MT-5111_001/ TRIO 035

    Treatment: Drug: MT-5111 (experimental study drug)

    Therapies Involved: Chemotherapy ID: NCT04029922

  • Objective

    To evaluate the safety and tolerability and determine the MTD (or
    RP2D) of MT-5111 in subjects with previously treated advanced
    HER2-positive solid tumors.

  • Key Eligibility

    1. Histologically confirmed, unresectable, locally advanced or metastatic solid cancers:
    Part 1 (Dose-Escalation): All HER2-positive solid cancers are eligible
    Part 2 (Dose-Expansion): Any type of HER2-positive solid cancer, including breast cancer, gastric or gastroesophageal adenocarcinomas (GEA).
    2. HER2-positive in the latest tumor sample tested for HER2 (testing to be done on a metastatic lesion in cases of metastatic cancers).
    3. Relapsed or refractory to or intolerant of existing therapy(ies)
    4. At least 1 measurable or evaluable lesion according to RECIST 1.1
    5. ECOG performance score of ≤ 1
    6. Bone marrow function:
    Absolute neutrophil count (ANC) ≥ 1,000/mm3
    Platelet count ≥ 75,000 mm³ and
    Hemoglobin ≥ 8.0 g/dL
    No red blood cell transfusion within 4 weeks of study treatment start is allowed
    7. Kidney function:
    (eGFR) ≥ 50 mL/min calculated by the Cockcroft-Gault formula
    Subjects with CLcr ≥ 50 mL/min will be eligible irrespective of the eGFR result
    8. Cardiac Function:
    Left ventricular ejection fraction (LVEF) ≥ 55% on the multigated acquisition (MUGA) scan (preferred) or echocardiogram (ECHO) assessment, and
    QTcF ≤ 480 ms for women and QTcF ≤ 450 ms for men [average from three QTcF values on the triplicate 12-lead electrocardiogram (ECG)] at baseline
    9.Hepatic function:
    Total bilirubin ≤ 1.5 x ULN, and
    AST ≤ 3 x ULN and ALT ≤ 3 x ULN

    < 5 x ULN (if hepatic metastases)