An Expanded Access Treatment Protocol of Zanidatamab (ZW25) in Patients With HER2-Positive Advanced Biliary Tract Cancer
NCT ID: NCT04578444
Last Updated: 2025-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NO_LONGER_AVAILABLE
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Conditions
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Interventions
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Zanidatamab
Administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adequate cardiac left ventricular function, as defined by left ventricular ejection fraction (LVEF) ≥ 50%
* Adequate organ function
* Ineligible to participate or has no access to an ongoing zanidatamab or other Zymeworks clinical study (e.g., ZW49 clinical study).
* Females of childbearing potential and non-sterile males must agree to practice highly effective methods of birth control for the duration of the study and for 12 months after the last dose of study drug. In addition, non-sterile males must avoid sperm donation for the duration of the study and for 12 months after the last dose of study drug.
Exclusion Criteria
* Systemic anti-cancer therapy ≤ 3 weeks before the first dose of zanidatamab.
* Radiotherapy ≤ 2 weeks of the first dose of zanidatamab
* The following central nervous system (CNS) brain lesions are excluded from the study:
* Untreated or unstable brain lesions requiring immediate local therapy or symptomatic CNS metastases.
* Radiation treatment for CNS metastases within 4 weeks before the first dose of zanidatamab.
* Known history of or ongoing leptomeningeal disease (LMD). If LMD has been reported radiographically, but is not suspected clinically by the investigator, the patient must be free of neurological symptoms of LMD.
* The following CNS brain lesions are permitted:
* Stable brain lesions are permitted if stable, as defined by patients who are off steroids and anticonvulsants and are neurologically stable with no evidence of radiographic progression for at least 4 weeks at the time of screening.
* Concurrent uncontrolled or active hepatobiliary disorders or untreated or ongoing complications after laparoscopic procedures or stent placement, including but not limited to active cholangitis, unresolved biliary obstruction, biloma or abscess. Any complications should be resolved within 2 weeks prior to the first dose of zanidatamab.
* Active hepatitis
* Infection with human immunodeficiency virus (HIV) with uncontrolled disease.
* Females who are breastfeeding or pregnant, and females and males planning a pregnancy.
* History of myocardial infarction or unstable angina within 6 months prior to enrollment, congestive heart failure (NYHA Class 3 or 4), or clinically significant cardiac disease
* QTc Fridericia (QTcF) \> 470 ms assessed within 30 days of screening
* Acute or chronic uncontrolled pancreatitis or Child-Pugh Class C liver disease
18 Years
ALL
No
Sponsors
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Jazz Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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NoCo Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
TOI Clinical Research
Cerritos, California, United States
Salinas Valley Memorial Healthcare System
Salinas, California, United States
Washington University School of Medicine
St Louis, Missouri, United States
Jean Minjoz Hospital
Besançon, , France
Hopital Timone Marseille
Marseille, , France
Hopital Haut-Leveque - CHU Bordeaux
Pessac, , France
Gustave Roussy Cancer Center
Villejuif, , France
ICCRS Candiolo
Candiolo, , Italy
Istituto Clinico Humanitas
Milan, , Italy
Istituto Nazionale Tumori
Milan, , Italy
Vall D'Hebron University Hospital
Barcelona, , Spain
Fundacion Jimenez Diaz University Hospital - Autonomous University of Madrid
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
The Princess Alexandra Hospital NHS Trust (Joanne Kwa, Pharmacist)
Harlow, , United Kingdom
UCLH Cancer Institute (Meera Desai, Pharmacist)
London, , United Kingdom
HCA Healthcare UK
London, , United Kingdom
Countries
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Other Identifiers
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ZWI-ZW25-EAP
Identifier Type: -
Identifier Source: org_study_id
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