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A Study of ZW251 in Participants With Advanced Solid Tumors
NCT07164313 · Zymeworks BC Inc.
In plain English
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Official title
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
About this study
Part 1 (dose escalation) of the study will evaluate the safety and tolerability of ZW251 in HCC, squamous cell NSCLC, and GCT. Part 2 (dose optimization) of the study will further assess safety and potential anti-tumor activity of the ZW251 established recommended doses in HCC.
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
Study design
Enrollment target: 100 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-10-21
Estimated completion: 2028-05
Last updated: 2026-04-14
Interventions
Drug: ZW251
Primary outcomes
- • Incidence of dose-limiting toxicities (DLTs; Part 1) (Up to 3 weeks)
- • Incidence of AEs (Parts 1 and 2) (Up to approximately 2 years)
- • Incidence of clinical laboratory abnormalities (Parts 1 and 2) (Up to approximately 2 years)
Sponsor
Zymeworks BC Inc. · industry
Contacts & investigators
ContactZymeworks Clinical Trial Resource · contact · medinfo@zymeworks.com · (206) 237-1030
InvestigatorMaggie Weinstein, MD, PhD, MPH · study_director, Zymeworks BC Inc.
All locations (23)
UCSF Comprehensive Cancer CenterRecruiting
San Francisco, California, United States
University of California Los Angeles - Cancer Care - Santa Monica (UCLA)Recruiting
Santa Monica, California, United States
Norton Cancer InstituteRecruiting
Louisville, Kentucky, United States
START MidwestRecruiting
Grand Rapids, Michigan, United States
Hackensack University Medical CenterRecruiting
Hackensack, New Jersey, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
START San AntonioRecruiting
San Antonio, Texas, United States
START - Dublin Mater Misericordiae University Hospital (MMUH)Recruiting
Dublin, Ireland
National Cancer Center EastRecruiting
Kashiwa, Japan
Kyoto University HospitalRecruiting
Kyoto, Japan
Kansai Medical University HospitalRecruiting
Osaka, Japan
National Cancer Center HospitalRecruiting
Tokyo, Japan
START Lisboa a - Unidade de Ensaios ClÃnicos - Hospital de Santa MariaRecruiting
Lisbon, Portugal
Hospital Universitario Vall d'HebronRecruiting
Barcelona, Spain
START BarcelonaRecruiting
Barcelona, Spain
START - Rioja Hospital Universitario San PedroRecruiting
Logroño, Spain
START Madrid Hospital Universitario Fundacion Jimenez DiazRecruiting
Madrid, Spain
START Madrid Hospital Universitario HM Sanchinarro - CIOCCRecruiting
Madrid, Spain
NEXT Oncology MadridRecruiting
Madrid, Spain
Hospital Universitario Virgen de la VictoriaRecruiting
Málaga, Spain
Clinica Universidad de NavarraRecruiting
Pamplona, Spain
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan