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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Must not have
Active or recurrent clinically significant autoimmune disease requiring systemic high-dose corticosteroids or immunosuppressive drugs
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is looking into whether ZW171 is a safe and effective treatment for people with advanced mesothelin-expressing cancers.
Who is the study for?
This trial is for individuals with advanced or metastatic cancers that express mesothelin, meaning their cancer cells have a specific protein. Details on who can join are not fully provided, but typically participants need to meet certain health standards and may be required to have tried other treatments first.
What is being tested?
The study is testing ZW171's safety and effectiveness in treating advanced or metastatic mesothelin-expressing cancers. It aims to determine the appropriate dosage and observe any potential benefits in shrinking or controlling the cancer.
What are the potential side effects?
Specific side effects of ZW171 are not listed, but common ones for cancer treatments include nausea, fatigue, risk of infection, allergic reactions, and organ-specific issues. The exact side effects will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My heart's left ventricle pumps well, with an efficiency of 50% or more.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am on high-dose steroids or immunosuppressants for an autoimmune disease.
Select...
My advanced cancer is causing severe symptoms or life-threatening complications.
Select...
I have another cancer that is getting worse or needed treatment.
Select...
I have had a transplant of stem cells or an organ in the last 5 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Confirmed objective response rate (Part 2)
Incidence of adverse events (AEs; Parts 1 and 2)
Incidence of clinical laboratory abnormalities (Parts 1 and 2)
+3 moreSecondary study objectives
Confirmed objective response rate (Part 1)
Disease control rate (DCR; Part 2)
Duration of response (DOR; Part 2)
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ZW171Experimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Zymeworks BC Inc.Lead Sponsor
5 Previous Clinical Trials
1,155 Total Patients Enrolled
Pranshul Chauhan, MSc, MB, BCh, BAOStudy DirectorZymeworks BC Inc.
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