NCT07164313RecruitingPhase 1
A Study of ZW251 in Participants With Advanced Solid Tumors
A First-In-Human, Phase 1, Open-Label, Multicenter Study of ZW251, a Novel Glypican-3 Targeting Antibody-Drug Conjugate, in Participants With Advanced Solid Tumors, Including Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 27 Aug 2025
- Start date
- 21 Oct 2025
- Primary completion date
- Sept 2027
- Lead sponsor
- Zymeworks BC Inc.
- NCT number
- NCT07164313
- EudraCT number
- 2025-523088-39
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 140
- From 21 Oct 2025 to the primary completion date, Sept 2027
- 25 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Known gastrointestinal bleeding within 3 months
- Acute or chronic uncontrolled renal disease, pancreatitis, or non-malignant liver disease
Other
- Participants with HCC experiencing main portal vein tumor invasion require sponsor approval for enrollment
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| START Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| START - Rioja Hospital Universitario San Pedro Coordinator of this site? Confirm its status | Logroño | Spain | Recruiting |
| START MADRID_Hospital Universitario HM Sanchinarro - CIOCC Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| NEXT Oncology Madrid Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| START Madrid / Hospital Universitario Fundacion Jimenez Diaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| START - Dublin Mater Misericordiae University Hospital (MMUH) Coordinator of this site? Confirm its status | Dublin | Ireland | Recruiting |
| National Cancer Center East Coordinator of this site? Confirm its status | Kashiwa | Japan | Recruiting |
| Kyoto University Hospital Coordinator of this site? Confirm its status | Kyoto | Japan | Recruiting |
| Kansai Medical University Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Recruiting |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| START Lisboa a - Unidade de Ensaios ClÃnicos - Hospital de Santa Maria Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Unidade Local de Saúde Gaia e Espinho Coordinator of this site? Confirm its status | Vila Nova de Gaia | Portugal | Recruiting |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| START | Midwest Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| Hackensack University Medical Center Coordinator of this site? Confirm its status | Hackensack | United States | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Norton Cancer Institute Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| START | San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| UCSF Comprehensive Cancer Center Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| University of California Los Angeles - Cancer Care - Santa Monica (UCLA) Coordinator of this site? Confirm its status | Santa Monica | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.