Status:
TERMINATED
A Study of ZW171 in Participants With Advanced or Metastatic Mesothelin-expressing Cancers
Lead Sponsor:
Zymeworks BC Inc.
Conditions:
Mesothelin-expressing Advanced Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06523803
Start Date
September 30 2024
End Date
October 1 2025
Last Update
October 21 2025
Active Locations (15)
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1
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90089
2
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
3
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
4
Icahn School of Medicine at Mount Sinai (ISMMS) - The Blavatnik Family-Chelsea Medical Center
New York, New York, United States, 10011