Status:
RECRUITING
A Study of ZW191 in Participants With Solid Tumors
Lead Sponsor:
Zymeworks BC Inc.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to find out if ZW191 is safe and can treat participants with advanced cancers, including ovarian, endometrial, and non-small cell lung cancers.
Detailed Description
Part 1 of the study will evaluate the safety and tolerability of ZW191. Part 2 of the study will further evaluate safety and explore the potential anti-tumor activity of ZW191.
Eligibility Criteria
Inclusion
- Pathologically or cytologically confirmed diagnosis of cancers with evidence of locally advanced (unresectable), recurrent and/or metastatic disease.
- Measurable disease per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- 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).
- Other adequate organ function.
Exclusion
- 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.
- Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease.
- Severe chronic or active infections (including known active SARS-CoV-2 infection) requiring systemic therapy, including antibacterial, antifungal, or antiviral therapy.
Key Trial Info
Start Date :
October 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT06555744
Start Date
October 30 2024
End Date
January 1 2027
Last Update
July 22 2025
Active Locations (18)
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1
Yale University
New Haven, Connecticut, United States, 06510
2
The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
Columbus, Ohio, United States, 43210
3
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
4
NEXT Oncology
San Antonio, Texas, United States, 78229