A Study of ZW251 in Participants With Advanced Solid Tumors
Recruiting now · Phase 1
Conditions studied: Hepatocellular Carcinoma, Squamous Cell Non-Small Cell Lung Cancer, Germ Cell Tumor
In brief
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).
Key facts
- Study ID
- NCT07164313
- Run by
- Zymeworks BC Inc.
- People needed
- 100
- Starts
- 2025-10-21
- Expected to finish
- 2028-05-01
- Last updated by the study team
- 2026-05-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 qualify 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
Where it is running
- Kyoto University Hospital — Kyoto, Japan (enrolling)
- Kansai Medical University Hospital — Osaka, Japan (enrolling)
- National Cancer Center Hospital — Tokyo, Japan (enrolling)
- START Lisboa a - Unidade de Ensaios ClÃnicos - Hospital de Santa Maria — Lisbon, Portugal (enrolling)
- Unidade Local de Saúde Gaia e Espinho — Vila Nova de Gaia, Portugal (enrolling)
- Hospital Universitario Vall d'Hebron — Barcelona, Spain (enrolling)
- START Barcelona — Barcelona, Spain (enrolling)
- START - Rioja Hospital Universitario San Pedro — Logroño, Spain (enrolling)
- START Madrid Hospital Universitario Fundacion Jimenez Diaz — Madrid, Spain (enrolling)
- START Madrid Hospital Universitario HM Sanchinarro - CIOCC — Madrid, Spain (enrolling)
- NEXT Oncology Madrid — Madrid, Spain (enrolling)
- Hospital Universitario Virgen de la Victoria — Málaga, Spain (enrolling)
- Clinica Universidad de Navarra — Pamplona, Spain (enrolling)
- National Taiwan University Hospital — Taipei, Taiwan (enrolling)
- Taipei Veterans General Hospital — Taipei, Taiwan (enrolling)
- UCSF Comprehensive Cancer Center — San Francisco, California, United States (enrolling)
- University of California Los Angeles - Cancer Care - Santa Monica (UCLA) — Santa Monica, California, United States (enrolling)
- Norton Cancer Institute — Louisville, Kentucky, United States (enrolling)
- START Midwest — Grand Rapids, Michigan, United States (enrolling)
- Hackensack University Medical Center — Hackensack, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
- MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- START San Antonio — San Antonio, Texas, United States (enrolling)
- START - Dublin Mater Misericordiae University Hospital (MMUH) — Dublin, Ireland (enrolling)
- National Cancer Center East — Kashiwa, Japan (enrolling)
Full record on ClinicalTrials.gov
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