RecruitingPhase 1NCT07164313

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

Sponsor

Zymeworks BC Inc.

Enrollment

100 participants

Start Date

Oct 21, 2025

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma Germ Cell Tumor Squamous Cell Non Small Cell Lung Cancer

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called ZW251 in people with advanced liver cancer (hepatocellular carcinoma, or HCC) that cannot be surgically removed or has spread. It is a first-in-human dose-escalation study to find the right dose and check safety. **You may be eligible if...** - You have confirmed advanced or metastatic liver cancer (HCC) - You have measurable disease visible on scans - You are in good physical health (ECOG 0 or 1) - Your liver function is adequate (Child-Pugh Class A) - Your organ function meets required lab thresholds **You may NOT be eligible if...** - You have another active or recently treated cancer - You have had a history of liver confusion (hepatic encephalopathy) in the past 6 months - You have had a blood clot in the portal vein within 3 months that is unstable - You have fluid around your lungs or abdomen that is uncontrolled Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZW251

Administered intravenously

Locations(25)

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

START - Dublin Mater Misericordiae University Hospital (MMUH)

Dublin, Ireland

National Cancer Center East

Kashiwa, Japan

Kyoto University Hospital

Kyoto, Japan

Kansai Medical University Hospital

Osaka, Japan

National Cancer Center Hospital

Tokyo, Japan

START Lisboa a - Unidade de Ensaios ClÃnicos - Hospital de Santa Maria

Lisbon, Portugal

Unidade Local de Saúde Gaia e Espinho

Vila Nova de Gaia, Portugal

Hospital Universitario Vall d'Hebron

Barcelona, Spain

START Barcelona

Barcelona, Spain

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

Clinica Universidad de Navarra

Pamplona, Spain

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07164313

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