A Study of ZW191 in Participants With Solid Tumors

Last updated: April 4, 2025
Sponsor: Zymeworks BC Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

ZW191

Clinical Study ID

NCT06555744
ZWI-ZW191-101
2024-512299-37-00
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pathologically or cytologically confirmed diagnosis of cancers with evidence oflocally 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 leftventricular ejection fraction (LVEF) ≥ 50% as determined by either echocardiogram (ECHO) or multigated acquisition scan (MUGA).

  • Other adequate organ function.

Exclusion

Exclusion Criteria:

  • Known additional malignancy that is progressing or requires active treatment or mayinterfere with study endpoints.

  • Has received prior Topoisomerase I inhibitor(TOPO1i) antibody drug conjugatetreatment, 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 antiviraltherapy.

Study Design

Total Participants: 145
Treatment Group(s): 1
Primary Treatment: ZW191
Phase: 1
Study Start date:
October 30, 2024
Estimated Completion Date:
January 31, 2027

Study 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.

Connect with a study center

  • Linear Clinical Research

    Nedlands, WA 6009
    Australia

    Active - Recruiting

  • Royal North Shore Hospital Northern Sydney Cancer Centre

    St Leonards, NSW 2065
    Australia

    Active - Recruiting

  • National Cancer Center Hospital East

    Kashiwa-shi, 277-8577
    Japan

    Active - Recruiting

  • Saitama Medical University International Medical Center

    Saitama, 350-1298
    Japan

    Active - Recruiting

  • National Cancer Center Hospital

    Tokyo, 104-0045
    Japan

    Active - Recruiting

  • National Cancer Center

    Goyang-si, 10408
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • National Cancer Centre Singapore

    Singapore, 168583
    Singapore

    Active - Recruiting

  • National University Health System (NUHS) - National University Cancer Institute Singapore (NCIS)

    Singapore, 119228
    Singapore

    Active - Recruiting

  • Yale University

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • NEXT Oncology

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • NEXT Virginia

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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