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Monoclonal Antibodies
ZW191 for Advanced Cancers
Phase 1
Recruiting
Research Sponsored by Zymeworks BC Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologically or cytologically confirmed diagnosis of cancers with evidence of locally advanced (unresectable), recurrent and/or metastatic disease
Adequate cardiac function: Cardiac left ventricular function, as defined by left ventricular ejection fraction (LVEF) ≥ 50% as determined by either echocardiogram (ECHO) or multigated acquisition scan (MUGA)
Must not have
Known additional malignancy that is progressing or requires active treatment or may interfere with study endpoints
Has received prior Topoisomerase I inhibitor(TOPO1i) antibody drug conjugate treatment, regardless of washout period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights
No Placebo-Only Group
Summary
"This trial is testing a new drug called ZW191 to see if it is safe and effective in treating advanced cancers such as ovarian, endometrial, and non-small cell lung cancers."
Who is the study for?
This trial is for people with advanced cancers like ovarian, endometrial, and non-small cell lung cancer. Participants must have a confirmed diagnosis of these cancers that are advanced or metastatic, measurable by certain criteria (RECIST v1.1), good heart function (LVEF ≥ 50%), and be in fairly good health overall (ECOG score of 0 or 1).
What is being tested?
The study is testing ZW191 to see if it's safe and effective for treating participants with specific types of advanced cancers. It aims to understand the appropriate dosage and assess how well tumors respond to this treatment.
What are the potential side effects?
While the side effects of ZW191 aren't listed here, common side effects from cancer treatments can include fatigue, nausea, vomiting, hair loss, increased risk of infection due to lowered blood counts, and potential organ-specific issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced, cannot be surgically removed, has come back, or has spread.
Select...
My heart pumps well, with an ejection fraction of 50% or higher.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have another cancer that is getting worse or needs treatment.
Select...
I have been treated with a TOPO1i antibody drug before.
Select...
I do not have uncontrolled kidney, pancreas, or liver disease.
Select...
I do not have severe or active infections needing treatment.
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)
+1 moreSecondary study objectives
Clinical benefit rate (Parts 1 and 2)
Confirmed objective response rate (Part 1)
Disease control rate (DCR; 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: ZW191Experimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Zymeworks BC Inc.Lead Sponsor
5 Previous Clinical Trials
1,170 Total Patients Enrolled
Josemund Menezes, MBBS, BCMASStudy DirectorZymeworks BC Inc.
Joseph Woolery, PharmD, BCOPStudy DirectorZymeworks BC Inc.
4 Previous Clinical Trials
302 Total Patients Enrolled