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Recruiting NCT07164313

A Study of ZW251 in Participants With Advanced Solid Tumors

Phase I Interventional Hepatocellular Carcinoma Squamous Cell Non-Small Cell Lung Cancer Germ Cell Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ZW251.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma, Squamous Cell Non-Small Cell Lung Cancer, Germ Cell Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Ireland, Japan, Portugal, Spain +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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).

Detailed description

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.

Interventions

  • Drug ZW251
    Administered intravenously

Primary outcome measures

  • Incidence of dose-limiting toxicities (DLTs; Part 1) [Time frame: Up to 3 weeks]
  • Incidence of AEs (Parts 1 and 2) [Time frame: Up to approximately 2 years]
  • Incidence of clinical laboratory abnormalities (Parts 1 and 2) [Time frame: Up to approximately 2 years]
  • Objective response rate (Part 2) [Time frame: Up to approximately 2 years]
Secondary outcome measures (11)
  • Objective response rate (Part 1) [Time frame: Up to approximately 2 years]
  • Best overall response (Parts 1 and 2) [Time frame: Up to approximately 2 years]
  • Disease control rate (Parts 1 and 2) [Time frame: Up to approximately 2 years]
  • Duration of response (Parts 1 and 2) [Time frame: Up to approximately 2 years]
  • Progression-free survival (Part 2) [Time frame: Up to approximately 2 years]
  • Area under the concentration-time curve (AUC0-504) of ZW251 (Parts 1 and 2) [Time frame: Up to approximately 2 years]
  • Maximum concentration (Cmax) of ZW251 (Parts 1 and 2) [Time frame: Up to approximately 2 years]
  • Area under the concentration-time curve of ZW251 at steady state (AUCtau,ss; Parts 1 and 2) [Time frame: Up to approximately 2 years]
  • Maximum concentration of ZW251 at steady state (Сmax,ss; Parts 1 and 2) [Time frame: Up to approximately 2 years]
  • Minimal concentration of ZW251 at steady state (Сmin,ss; Parts 1 and 2) [Time frame: Up to approximately 2 years]
  • Incidence of anti-drug antibodies (ADAs; Parts 1 and 2) [Time frame: Up to approximately 2 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 8 centers
  • UCSF Comprehensive Cancer Center — San Francisco
  • University of California Los Angeles - Cancer Care - Santa Monica (UCLA) — Santa Monica
  • Norton Cancer Institute — Louisville
  • START Midwest — Grand Rapids
  • Hackensack University Medical Center — Hackensack
  • Memorial Sloan Kettering Cancer Center — New York
  • MD Anderson Cancer Center — Houston
  • START San Antonio — San Antonio
Spain · 8 centers
  • Hospital Universitario Vall d'Hebron — Barcelona
  • START Barcelona — Barcelona
  • START - Rioja Hospital Universitario San Pedro — Logroño
  • START Madrid Hospital Universitario Fundacion Jimenez Diaz — Madrid
  • START Madrid Hospital Universitario HM Sanchinarro - CIOCC — Madrid
  • NEXT Oncology Madrid — Madrid
  • Hospital Universitario Virgen de la Victoria — Málaga
  • Clinica Universidad de Navarra — Pamplona
Japan · 4 centers
  • National Cancer Center East — Kashiwa
  • Kyoto University Hospital — Kyoto
  • Kansai Medical University Hospital — Osaka
  • National Cancer Center Hospital — Tokyo
Portugal · 2 centers
  • START Lisboa a - Unidade de Ensaios ClÃnicos - Hospital de Santa Maria — Lisbon
  • Unidade Local de Saúde Gaia e Espinho — Vila Nova de Gaia
Taiwan · 2 centers
  • National Taiwan University Hospital — Taipei
  • Taipei Veterans General Hospital — Taipei
Ireland · 1 center
  • START - Dublin Mater Misericordiae University Hospital (MMUH) — Dublin

Identifiers

NCT: NCT07164313 · ZWI-ZW251-101 · 2025-523088-39

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗