Actively Recruiting
A First-In-Human Study of ZW251, a Glypican-3 Targeting Antibody-Drug Conjugate, in Participants With Advanced Solid Tumors Including Hepatocellular Carcinoma
Led by Zymeworks BC Inc. · Updated on 2026-05-07
100
Participants Needed
25
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ZW251, an antibody-drug conjugate targeting glypican-3 (GPC3), in people with advanced cancers such as hepatocellular carcinoma (HCC), squamous cell non-small cell lung cancer (NSCLC), and germ cell tumors (GCT). The study aims to assess whether ZW251 is safe and can treat these cancers. This is a phase 1, open-label, multicenter trial sponsored by Zymeworks BC Inc. The study has two parts: Part 1 focuses on dose escalation to test the safety and tolerability of ZW251 in participants with HCC, squamous cell NSCLC, and GCT. Part 2 involves dose optimization to further evaluate safety and potential anti-tumor effects of the recommended doses in participants with HCC. ZW251 is administered intravenously during the study. Participants will be monitored for dose-limiting toxicities, adverse events, laboratory abnormalities, and tumor responses for up to approximately two years. Researchers will assess tumor size changes, disease control, response duration, and progression-free survival. Blood samples will be taken to measure drug concentration and immune reactions. Safety and treatment effects will be closely followed throughout the study.
CONDITIONS
Brief Title
A Study of ZW251 in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically or cytologically confirmed diagnosis of hepatocellular carcinoma with locally advanced (unresectable, ineligible for transplant) and/or metastatic disease, or squamous cell non-small cell lung cancer with locally advanced (unresectable) and/or metastatic disease, or germ cell tumor with yolk sac and/or choriocarcinoma predominant component and locally advanced (unresectable) and/or metastatic disease
- Measurable disease according to RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Liver function status of Child-Pugh Class A (for hepatocellular carcinoma only)
- Adequate organ function
- Age 18 years or older
You will not qualify if you...
- Known additional malignancy that is progressing or required active treatment within the last year
- History of hepatic encephalopathy within the past 6 months or need for medication to control encephalopathy
- Participants with hepatocellular carcinoma and main portal vein tumor invasion require sponsor approval to enroll
- Known gastrointestinal bleeding within the past 3 months
- Acute or chronic uncontrolled renal disease, pancreatitis, or non-malignant liver disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 2 years
Participants receive the study drug ZW251 administered intravenously to evaluate safety, tolerability, and potential anti-tumor activity.
Visits occur regularly during treatment for drug administration and monitoring
Trial Site Locations
Total: 25 locations
1
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94158
Actively Recruiting
2
University of California Los Angeles - Cancer Care - Santa Monica (UCLA)
Santa Monica, California, United States, 90404
Actively Recruiting
3
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
Actively Recruiting
4
START Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
5
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065-6800
Actively Recruiting
7
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
8
START San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
9
START - Dublin Mater Misericordiae University Hospital (MMUH)
Dublin, Ireland, D07 R2WY
Actively Recruiting
10
National Cancer Center East
Kashiwa, Japan, 2778577
Actively Recruiting
11
Kyoto University Hospital
Kyoto, Japan, 606-8507
Actively Recruiting
12
Kansai Medical University Hospital
Osaka, Japan, 573-1191
Actively Recruiting
13
National Cancer Center Hospital
Tokyo, Japan, 104-0045
Actively Recruiting
14
START Lisboa a - Unidade de Ensaios ClÃnicos - Hospital de Santa Maria
Lisbon, Portugal, 1649-035
Actively Recruiting
15
Unidade Local de Saúde Gaia e Espinho
Vila Nova de Gaia, Portugal, 4434-502
Actively Recruiting
16
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
17
START Barcelona
Barcelona, Spain, 29010
Actively Recruiting
18
START - Rioja Hospital Universitario San Pedro
Logroño, Spain, 26006
Actively Recruiting
19
START Madrid Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
20
START Madrid Hospital Universitario HM Sanchinarro - CIOCC
Madrid, Spain, 28050
Actively Recruiting
21
NEXT Oncology Madrid
Madrid, Spain, 28223
Actively Recruiting
22
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Actively Recruiting
23
Clinica Universidad de Navarra
Pamplona, Spain, 31008
Actively Recruiting
24
National Taiwan University Hospital
Taipei, Taiwan, 100225
Actively Recruiting
25
Taipei Veterans General Hospital
Taipei, Taiwan, 112201
Actively Recruiting
Research Team
Z
Zymeworks Clinical Trial Resource
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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