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

Stopped early · Phase 1

Conditions studied: Mesothelin-expressing Advanced Cancers

In brief

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.

Key facts

Study ID

NCT06523803

Run by

Zymeworks BC Inc.

People needed

32

Starts

2024-09-30

Expected to finish

2025-10-01

Last updated by the study team

2025-10-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Southern California - Norris Comprehensive Cancer Center — Los Angeles, California, United States
• University of Colorado Health Sciences Center — Aurora, Colorado, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Icahn School of Medicine at Mount Sinai (ISMMS) - The Blavatnik Family-Chelsea Medical Center — New York, New York, United States
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• University of Washington — Seattle, Washington, United States
• Universitaetsklinikum Dresden — Dresden, Germany
• Seoul National University Hospital — Seoul, South Korea
• Yonsei University Health System - Severance Hospital — Seoul, South Korea
• Samsung Medical Center — Seoul, South Korea
• The Catholic University of Korea, Seoul St. Marys Hospital — Seoul, South Korea
• Guys and St Thomas' NHS Foundation Trust — London, United Kingdom
• The Christie NHS Foundation Trust — Manchester, United Kingdom
• Royal Marsden Hospital — Sutton, United Kingdom

Full record on ClinicalTrials.gov

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