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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
