About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • ZW251

Treatment groups

100 Participants
are divided into 1 treatment group

Locations

25
Ireland
START - Dublin Mater Misericordiae University Hospital (MMUH)D07 R2WY, Dublin Ireland
Japan
National Cancer Center East2778577, Kashiwa Japan
Kyoto University Hospital606-8507, Kyoto Japan
Kansai Medical University Hospital573-1191, Osaka Japan

Sponsors and collaborators

Zymeworks BC Inc.

Lead sponsor