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A Study of ZW251 in Participants With Advanced Solid Tumors
Trial Status: active
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).
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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07164313.
