A Study of ZW251 in Participants With Advanced Solid Tumors
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).
| Condition(s) | Hepatocellular Carcinoma, Squamous Cell Non-Small Cell Lung Cancer, Germ Cell Tumor |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | 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). |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Zymeworks BC Inc. |
| Locations | San Francisco, California, United States; Santa Monica, California, United States; Louisville, Kentucky, United States; Grand Rapids, Michigan, United States; Hackensack, New Jersey, United States; New York, New York, United States (+19 more sites) |
| Start date | 2025-10-21 |
| NCT ID | NCT07164313 |
| Official listing | https://clinicaltrials.gov/study/NCT07164313 |