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Phase I

A Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Ascending Doses of a Folate Receptor Alpha Antibody Drug Conjugate, ZW191, in Participants With Advanced Solid Tumors

  • Study HIC#:2000038772
  • Last Updated:03/13/2025

The purpose of this study is to find out if ZW191 is safe and can treat participants with advanced cancers, including ovarian, endometrial, and non-small cell lung cancers.

    Contact Us

    For more information about this study, including how to volunteer, contact:

    Ingrid Palma

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    You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.

    Trial Purpose and Description

    Part 1 of the study will evaluate the safety and tolerability of ZW191. Part 2 of the study will further evaluate safety and explore the potential anti-tumor activity of ZW191.

    Eligibility Criteria

    Inclusion Criteria:

    • Pathologically or cytologically confirmed diagnosis of cancers with evidence of locally advanced (unresectable), recurrent and/or metastatic disease.
    • Measurable disease per RECIST v1.1.
    • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
    • Adequate cardiac function: Cardiac left ventricular function, as defined by left ventricular ejection fraction (LVEF) ≥ 50% as determined by either echocardiogram (ECHO) or multigated acquisition scan (MUGA).
    • Other adequate organ function.

    Exclusion Criteria:

    • Known additional malignancy that is progressing or requires active treatment or may interfere with study endpoints.
    • Has received prior Topoisomerase I inhibitor(TOPO1i) antibody drug conjugate treatment, regardless of washout period.
    • Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease.
    • Severe chronic or active infections (including known active SARS-CoV-2 infection) requiring systemic therapy, including antibacterial, antifungal, or antiviral therapy.

    Principal Investigator

    Sub-Investigators

    For more information about this study, including how to volunteer, contact: