A Study of ZW251 in Participants With Advanced Solid Tumors
Purpose
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 (HCC).
Condition
- Hepatocellular Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 Criteria
- 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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ZW251 |
|
Recruiting Locations
Norton Cancer Institute
Louisville 4299276, Kentucky 6254925 40202
Louisville 4299276, Kentucky 6254925 40202
START Midwest
Grand Rapids 4994358, Michigan 5001836 49546
Grand Rapids 4994358, Michigan 5001836 49546
Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760 07601
Hackensack 5098706, New Jersey 5101760 07601
MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
START San Antonio
San Antonio 4726206, Texas 4736286 78229
San Antonio 4726206, Texas 4736286 78229
More Details
- Status
- Recruiting
- Sponsor
- Zymeworks BC Inc.
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 the ZW251 established recommended doses in HCC.