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A Study of ZW251 in Participants With Advanced Solid Tumors
A First-In-Human, Phase 1, Open-Label, Multicenter Study of ZW251, a Novel Glypican-3 Targeting Antibody-Drug Conjugate, in Participants With Advanced Solid Tumors, Including Hepatocellular Carcinoma
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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).
What is being tested
- ZW251 (drug)
Sponsor: Zymeworks BC Inc. · Participants: 100 · Started: Oct 21, 2025
Contact the study team
- Zymeworks Clinical Trial Resource · Phone: (206) 237-1030
Official record on ClinicalTrials.gov — NCT07164313
Locations in the U.S.
Conditions
- Liver Cancer (Hepatocellular Carcinoma)
- Germ Cell and Embryonal Cancer
- Lung Cancer
- Non-Small Cell Lung Cancer
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.