A Study of ZW171 in Participants With Advanced or Metastatic Mesothelin-expressing Cancers

NCT ID: NCT06523803

Last Updated: 2025-10-21

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2025-10-01

Brief Summary

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This study is being done to find out if ZW171 is safe and can treat participants with advanced (locally advanced \[inoperable\] and/or metastatic) mesothelin-expressing cancers.

Detailed Description

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Part 1 of the study will evaluate the safety and tolerability of ZW171. Part 2 of the study will evaluate the anti-tumor activity of ZW171 while continuing to evaluate the safety and tolerability.

Conditions

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Mesothelin-expressing Advanced Cancers

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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ZW171

Group Type EXPERIMENTAL

ZW171

Intervention Type DRUG

Administered per protocol requirements

Interventions

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ZW171

Administered per protocol requirements

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pathologically confirmed diagnosis of cancers with evidence of locally advanced (unresectable) and/or metastatic disease. Cancers that are refractory to all available standard of care (SOC) treatment, cancers for which no SOC treatment is available, or the participant cannot tolerate or refuses SOC therapy.
* An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
* Adequate cardiac left ventricular function, as defined by left ventricular ejection fraction ≥ 50% as determined by either echocardiogram or multigated acquisition scan.
* Adequate organ function.

Exclusion Criteria

* Known additional malignancy that is progressing or that has required active treatment.
* Undergone prior allogenic tissue (e.g., hematopoietic stem cell) or solid organ transplantation within the last 5 years.
* Ongoing, clinically significant toxicity (Grade ≥ 2) associated with prior cancer therapies, with the exception of alopecia.
* Advanced/metastatic, symptomatic, visceral spread, at risk of life-threatening complications in the short-term (including participants with massive uncontrolled effusion \[pleural, pericardial\], pulmonary lymphangitis, active unresolved bowel obstruction, massive ascites \[requiring paracentesis \>2 times within 2 weeks prior to the first dose\], and over 50% liver involvement).
* Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease (with exception of participants with Gilbert's Syndrome, asymptomatic gall stones, liver metastases, or stable chronic liver disease per investigator assessment).
* Active or recurrent clinically significant autoimmune disease requiring systemic high-dose corticosteroids or immunosuppressive drugs.
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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Pranshul Chauhan, MSc, MB, BCh, BAO

Role: STUDY_DIRECTOR

Zymeworks BC Inc.

Locations

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University of Southern California - Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

University of Colorado Health Sciences Center

Aurora, Colorado, United States

Site Status

Norton Cancer Institute

Louisville, Kentucky, United States

Site Status

Icahn School of Medicine at Mount Sinai (ISMMS) - The Blavatnik Family-Chelsea Medical Center

New York, New York, United States

Site Status

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Universitaetsklinikum Dresden

Dresden, , Germany

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Yonsei University Health System - Severance Hospital

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

The Catholic University of Korea, Seoul St. Marys Hospital

Seoul, , South Korea

Site Status

Guys and St Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status

The Christie NHS Foundation Trust

Manchester, , United Kingdom

Site Status

Royal Marsden Hospital

Sutton, , United Kingdom

Site Status

Countries

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United States Germany South Korea United Kingdom

Other Identifiers

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2024-511119-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ZWI-ZW171-101

Identifier Type: -

Identifier Source: org_study_id

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