TERMINATED

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

Conditions

Mesothelin-expressing Advanced Cancers Advanced or Metastatic Cancers ADC Antibody drug conjugate

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1, Open-label, Multicenter Study of ZW171 in Participants With Advanced or Metastatic Ovarian Cancer, Non-small Cell Lung Cancer (NSCLC), and Other Mesothelin Expressing Cancers

Quick Facts

Study Start:2024-09-30

Study Completion:2025-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT06523803

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Pranshul Chauhan, MSc, MB, BCh, BAO

STUDY_DIRECTOR

Zymeworks BC Inc.

Study Locations (Sites)

University of Southern California - Norris Comprehensive Cancer Center

Los Angeles, California, 90089

United States

University of Colorado Health Sciences Center

Aurora, Colorado, 80045

United States

Norton Cancer Institute

Louisville, Kentucky, 40202

United States

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

New York, New York, 10011

United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

United States

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

United States

University of Washington

Seattle, Washington, 98195

United States

Collaborators and Investigators

Sponsor: Zymeworks BC Inc.

Pranshul Chauhan, MSc, MB, BCh, BAO, STUDY_DIRECTOR, Zymeworks BC Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-30

Study Completion Date2025-10-01

Study Record Updates

Study Start Date2024-09-30

Study Completion Date2025-10-01

Terms related to this study

Keywords Provided by Researchers

Advanced or Metastatic Cancers
ADC
Antibody drug conjugate

Additional Relevant MeSH Terms

Mesothelin-expressing Advanced Cancers