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Recruiting
NCT07164313
A Study of ZW251 in Participants With Advanced Solid Tumors
Conditions: Hepatocellular Carcinoma, Squamous Cell Non-Small Cell Lung Cancer, Germ Cell Tumor
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 140
Sponsor: Zymeworks BC Inc.
Location: UCSF Comprehensive Cancer Center San Francisco California
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).
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07164313). StuddyBuddy aggregates publicly available trial information.