RecruitingPhase 1NCT06555744

A Study of ZW191 in Participants With Solid Tumors

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


Sponsor

Zymeworks BC Inc.

Enrollment

145 participants

Start Date

Oct 30, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria4

  • 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.

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Interventions

DRUGZW191

Administered intravenously


Locations(27)

Yale University

New Haven, Connecticut, United States

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

Columbus, Ohio, United States

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

NEXT Oncology

San Antonio, Texas, United States

NEXT Virginia

Fairfax, Virginia, United States

Linear Clinical Research

Nedlands, Australia

Royal North Shore Hospital Northern Sydney Cancer Centre

St Leonards, Australia

National Cancer Center Hospital East

Kashiwa-shi, Japan

Saitama Medical University International Medical Center

Saitama, Japan

National Cancer Center Hospital

Tokyo, Japan

The Cancer Institute Hospital of JFCR

Tokyo, Japan

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

Singapore, Singapore

National Cancer Centre Singapore

Singapore, Singapore

Curie Oncology

Singapore, Singapore

National Cancer Center

Goyang-si, South Korea

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Gangnam Severance Hospital

Seoul, South Korea

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Universitario Reina Sofia

Córdoba, Spain

Clínica Universidad de Navarra

Madrid, Spain

NEXT Oncology Madrid

Madrid, Spain

Fundacion Instituto Valenciano de Oncologia (IVO)

Valencia, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

View Full Details on ClinicalTrials.gov

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NCT06555744


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