A Study of ZW191 in Participants With Solid Tumors

NCT ID: NCT06555744

Last Updated: 2025-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-30

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ZW191

Group Type EXPERIMENTAL

ZW191

Intervention Type DRUG

Administered intravenously

Interventions

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ZW191

Administered intravenously

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zymeworks BC Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Akira Kojima, MD

Role: STUDY_DIRECTOR

Zymeworks BC Inc.

Locations

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Yale University

New Haven, Connecticut, United States

Site Status RECRUITING

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

Columbus, Ohio, United States

Site Status RECRUITING

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

NEXT Oncology

San Antonio, Texas, United States

Site Status RECRUITING

NEXT Virginia

Fairfax, Virginia, United States

Site Status RECRUITING

Linear Clinical Research

Nedlands, , Australia

Site Status RECRUITING

Royal North Shore Hospital Northern Sydney Cancer Centre

St Leonards, , Australia

Site Status RECRUITING

National Cancer Center Hospital East

Kashiwa-shi, , Japan

Site Status RECRUITING

Saitama Medical University International Medical Center

Saitama, , Japan

Site Status RECRUITING

National Cancer Center Hospital

Tokyo, , Japan

Site Status RECRUITING

The Cancer Institute Hospital of JFCR

Tokyo, , Japan

Site Status RECRUITING

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

Singapore, , Singapore

Site Status RECRUITING

National Cancer Centre Singapore

Singapore, , Singapore

Site Status RECRUITING

National Cancer Center

Goyang-si, , South Korea

Site Status RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status RECRUITING

Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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United States Australia Japan Singapore South Korea

Central Contacts

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Zymeworks Clinical Trial Resource

Role: CONTACT

(206) 237-1030

Other Identifiers

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2024-512299-37-00

Identifier Type: CTIS

Identifier Source: secondary_id

ZWI-ZW191-101

Identifier Type: -

Identifier Source: org_study_id

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