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Clinical Trials in the USA / NCT07164313
Recruiting Phase 1

A Study of ZW251 in Participants With Advanced Solid Tumors

NCT07164313 · tracked via the Priya Life Science USA tracker
Sponsor
Zymeworks BC Inc
Phase
Phase 1
Started
2025-10-21
Last updated
2026-10-05

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
No
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)

FacilityCityRegionStatus
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 the USA

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

Other trials for the same condition

A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer Active, not recruiting
Study of RP2 in Combination With Second-line Therapy in Patients With Locally Advanced or Metastatic HCC Recruiting
A Study of Durvalumab or Tremelimumab Monotherapy, or Durvalumab in Combination With Tremelimumab or Bevacizumab in Advanced Hepatocellular Carcinoma Active, not recruiting
A Phase I/II Study to Evaluate AZD5851 in GPC3+ Advanced/Recurrent Hepatocellular Carcinoma Active, not recruiting
Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors 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 the USA