ZW251 for advanced liver, lung, and germ cell cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, multi-center study enrolls adults with advanced HCC, squamous cell NSCLC, or yolk sac/choriocarcinoma-predominant germ cell tumors to receive ZW251, an antibody-drug conjugate targeting glypican-3 (GPC3). Part 1 uses a dose-escalation design to define safety, tolerability, and a recommended dose, and Part 2 expands at the selected dose to further monitor safety and preliminary anti-tumor activity in HCC. Eligible participants must have measurable disease by RECIST v1.1, ECOG performance status 0–1, and adequate organ function, with HCC patients limited to Child-Pugh class A. Study visits and treatment are provided at participating academic and regional cancer centers in the United States.

Why it matters

Who can join: the full rules

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

Where it's running

• UCSF Comprehensive Cancer Center
  San Francisco, California, United States Recruiting
• University of California Los Angeles - Cancer Care - Santa Monica (UCLA)
  Santa Monica, California, United States Recruiting
• Norton Cancer Institute
  Louisville, Kentucky, United States Recruiting
• START Midwest
  Grand Rapids, Michigan, United States Recruiting
• Hackensack University Medical Center
  Hackensack, New Jersey, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Zymeworks Clinical Trial Resource
• Email: medinfo@zymeworks.com
• Phone: (206) 237-1030

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.