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), squamous cell non-small cell lung cancer (NSCLC), or germ cell tumors (GCT).
Conditions
- Hepatocellular Carcinoma
- Squamous Cell Non-Small Cell Lung Cancer
- Germ Cell Tumor
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 - Pathologically or cytologically confirmed diagnosis of squamous cell NSCLC with evidence of locally advanced (unresectable) and/or metastatic disease - Pathologically or cytologically confirmed diagnosis of GCT with evidence of yolk sac and/or choriocarcinoma predominant component and locally advanced (unresectable) and/or metastatic disease - 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 (for HCC only) - 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 - Participants with HCC experiencing main portal vein tumor invasion require sponsor approval for enrollment - 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
UCSF Comprehensive Cancer Center
San Francisco, California 94158
San Francisco, California 94158
University of California Los Angeles - Cancer Care - Santa Monica (UCLA)
Santa Monica, California 90404
Santa Monica, California 90404
Norton Cancer Institute
Louisville, Kentucky 40202
Louisville, Kentucky 40202
START Midwest
Grand Rapids, Michigan 49546
Grand Rapids, Michigan 49546
Hackensack University Medical Center
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
MD Anderson Cancer Center
Houston, Texas 77030
Houston, Texas 77030
START San Antonio
San Antonio, Texas 78229
San Antonio, Texas 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, squamous cell NSCLC, and GCT. Part 2 (dose optimization) of the study will further assess safety and potential anti-tumor activity of the ZW251 established recommended doses in HCC.