A Study of ZW251 in Participants With Advanced Solid Tumors

NCT07164313 · tracked via the Priya Life Science Spain tracker

Sponsor

Zymeworks BC Inc

Phase

Phase 1

Started

2025-10-21

Last updated

2026-05-07

Condition(s) studied

Hepatocellular CarcinomaSquamous Cell Non-Small Cell Lung CancerGerm Cell Tumor

Investigational drug(s) / intervention(s)

ZW251

ZW251: Administered intravenously

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Incidence of dose-limiting toxicities (DLTs; Part 1) — Up to 3 weeks
Number of participants who experienced a DLT. DLTs include specifically defined adverse events (AEs) considered to be related to ZW251
Incidence of AEs (Parts 1 and 2) — Up to approximately 2 years
Number of participants who experienced AEs, adverse events of special interest, or serious adverse events
Incidence of clinical laboratory abnormalities (Parts 1 and 2) — Up to approximately 2 years
Number of participants who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology or chemistry. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0
Objective response rate (Part 2) — Up to approximately 2 years
Number of participants who achieved a best overall response of either confirmed complete response (CR) or partial response (PR) during treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Trial sites (25)

Facility	City	Region	Status
UCSF Comprehensive Cancer Center	San Francisco	California	Recruiting
University of California Los Angeles - Cancer Care - Santa Monica (UCLA)	Santa Monica	California	Recruiting
Norton Cancer Institute	Louisville	Kentucky	Recruiting
START Midwest	Grand Rapids	Michigan	Recruiting
Hackensack University Medical Center	Hackensack	New Jersey	Recruiting
Memorial Sloan Kettering Cancer Center	New York	New York	Recruiting
MD Anderson Cancer Center	Houston	Texas	Recruiting
START San Antonio	San Antonio	Texas	Recruiting
START - Dublin Mater Misericordiae University Hospital (MMUH)	Dublin	Ireland	Recruiting
National Cancer Center East	Kashiwa	Japan	Recruiting
Kyoto University Hospital	Kyoto	Japan	Recruiting
Kansai Medical University Hospital	Osaka	Japan	Recruiting
National Cancer Center Hospital	Tokyo	Japan	Recruiting
START Lisboa a - Unidade de Ensaios ClÃnicos - Hospital de Santa Maria	Lisbon	Portugal	Recruiting
Unidade Local de Saúde Gaia e Espinho	Vila Nova de Gaia	Portugal	Recruiting
Hospital Universitario Vall d'Hebron	Barcelona	Spain	Recruiting
START Barcelona	Barcelona	Spain	Recruiting
START - Rioja Hospital Universitario San Pedro	Logroño	Spain	Recruiting
START Madrid Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain	Recruiting
START Madrid Hospital Universitario HM Sanchinarro - CIOCC	Madrid	Spain	Recruiting
NEXT Oncology Madrid	Madrid	Spain	Recruiting
Hospital Universitario Virgen de la Victoria	Málaga	Spain	Recruiting
Clinica Universidad de Navarra	Pamplona	Spain	Recruiting
National Taiwan University Hospital	Taipei	Taiwan	Recruiting
Taipei Veterans General Hospital	Taipei	Taiwan	Recruiting

More Zymeworks BC Inc. trials in Spain

A Study of ZW191 in Participants With Solid Tumors Active, not recruiting

Other trials for the same condition

Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma Active, not recruiting

Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400 Recruiting

A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation Active, not recruiting

The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (#HOPE4LIVER EU/UK) Active, not recruiting

Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07164313 on ClinicalTrials.gov ↗ ← All trials in Spain