A Study of ZW251 in Participants With Advanced Solid Tumors
Recruiting · NCT07164313 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
ZW251
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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 is running
25 locations listed across 6 US states.
- UCSF Comprehensive Cancer Center - San Francisco, California, United States
- University of California Los Angeles - Cancer Care - Santa Monica (UCLA) - Santa Monica, California, United States
- Norton Cancer Institute - Louisville, Kentucky, United States
- START Midwest - Grand Rapids, Michigan, United States
- Hackensack University Medical Center - Hackensack, New Jersey, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- MD Anderson Cancer Center - Houston, Texas, United States
- START San Antonio - San Antonio, Texas, United States
- Hospital Universitario Vall d'Hebron - Barcelona, Spain
- START Barcelona - Barcelona, Spain
- START - Dublin Mater Misericordiae University Hospital (MMUH) - Dublin, Ireland
- National Cancer Center East - Kashiwa, Japan
- Kyoto University Hospital - Kyoto, Japan
- START Lisboa a - Unidade de Ensaios ClÃnicos - Hospital de Santa Maria - Lisbon, Portugal
- START - Rioja Hospital Universitario San Pedro - Logroño, Spain
- START Madrid Hospital Universitario Fundacion Jimenez Diaz - Madrid, Spain
- START Madrid Hospital Universitario HM Sanchinarro - CIOCC - Madrid, Spain
- NEXT Oncology Madrid - Madrid, Spain
- Hospital Universitario Virgen de la Victoria - Málaga, Spain
- Kansai Medical University Hospital - Osaka, Japan
- Clinica Universidad de Navarra - Pamplona, Spain
- National Taiwan University Hospital - Taipei, Taiwan
- Taipei Veterans General Hospital - Taipei, Taiwan
- National Cancer Center Hospital - Tokyo, Japan
- Unidade Local de Saúde Gaia e Espinho - Vila Nova de Gaia, Portugal