Phase I dose-escalation study of BAY 1129980

An open-label Phase I dose-escalation study to evaluate the safety, tolerability, maximum tolerated dose, pharmacokinetics, and pharmacodynamics of the anti-C4.4a antibody drug conjugate BAY 1129980 in subjects with advanced solid tumors known to express C4.4a

February 21, 2018

  • Clinical Trial Information

    Trial Contact: Quintiliani, Jennifer; Jarquin-Castillo, Katherine

    Trial Phone: 321.843.2026 ; 321.841.1077

  • IRB No: 16.070.06

    Protocol Abbrev: Bayer 16044

    Principal Investigator: Jennifer E. Tseng, MD

    Sub Investigators: Johnson, Tirrell MD; Neely, Lindsey ARNP

    Phase: Drug: Phase I

    Age Group: Adult

    Secondary Protocol No: BAY1129980 / 16044

    Treatment: Medication

    Applicable Disease Sites: Head and Neck

    Therapies Involved: BAY 1129980 ID: NCT02134197

  • Objective

    To determine the safety, tolerability and maximum
    tolerated dose (MTD) of BAY 1129980.

  • Key Eligibility

    Subjects with histologically or cytologically confirmed
    advanced solid tumors are eligible.
    In the dose-escalation phase, the study population will
    be limited to solid tumor types known to express C4.4a
    (e.g., esophagus, cervix, ovary, urinary bladder and
    breast, and all other tumors of squamous cell carcinoma
    Treatment in the expansion phases will be restricted to
    subjects with C4.4a-expressing squamous cell
    carcinomas of non-small-cell lung cancer (NSCLC),
    esophageal (ESCC) and head & neck, and all other
    tumors of SCC.2