Status:
RECRUITING
A Study of ZW251 in Participants With Advanced Solid Tumors
Lead Sponsor:
Zymeworks BC Inc.
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to find out if ZW251, an antibody-drug conjugate targeting glypican-3 (GPC3), is safe and can treat participants with advanced cancers, including hepatocellular carcinoma ...
Detailed Description
Part 1 (dose escalation) of the study will evaluate the safety and tolerability of ZW251 in HCC. Part 2 (dose optimization) of the study will further assess safety and potential anti-tumor activity of...
Eligibility Criteria
Inclusion
- Pathologically or cytologically confirmed diagnosis of HCC with evidence of locally advanced (unresectable, and ineligible for transplant) and/or metastatic disease. Noninvasive methods may be used to confirm diagnosis
- Measurable disease per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Liver function status of Child-Pugh Class A
- Adequate organ function
Exclusion
- Known additional malignancy that is progressing or that has required active treatment within the last year
- History of hepatic encephalopathy within the past 6 months or requirement for medications to control encephalopathy
- Portal vein thrombosis within 3 months prior to Cycle 1 Day 1 that require coagulation therapy or is not stable
- Known gastrointestinal bleeding within 3 months
- Acute or chronic uncontrolled renal disease, pancreatitis, or non-malignant liver disease
Key Trial Info
Start Date :
October 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07164313
Start Date
October 21 2025
End Date
May 1 2028
Last Update
November 12 2025
Active Locations (3)
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1
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
2
START Midwest
Grand Rapids, Michigan, United States, 49546
3
START San Antonio
San Antonio, Texas, United States, 78229