An Expanded Access Treatment Protocol of Zanidatamab (ZW25) in Patients With HER2-Positive Advanced Biliary Tract Cancer
Expanded Access Use of Zanidatamab for the Treatment of HER2-Positive Advanced Solid Tumor
1 other identifier
expanded_access
N/A
5 countries
17
Brief Summary
This is an intermediate-size Expanded Access Protocol (EAP) for use of zanidatamab (ZW25) in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced biliary tract cancer (BTC) who are not eligible for other zanidatamab clinical trials, and who in the opinion of the treating oncologist, would potentially benefit from treatment with zanidatamab.
Trial Health
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17 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2020
CompletedFirst Posted
Study publicly available on registry
October 8, 2020
CompletedMay 25, 2025
May 1, 2025
September 30, 2020
May 21, 2025
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed HER2-positive locally advanced or metastatic biliary tract cancer that has progressed after receipt of available therapies known to confer clinical benefit.
- 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.
You may not qualify if:
- Participating in other studies involving investigational drug(s) ≤ 3 weeks before the first dose of zanidatamab.
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
NoCo Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
TOI Clinical Research
Cerritos, California, 90603, United States
Salinas Valley Memorial Healthcare System
Salinas, California, 93901, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Jean Minjoz Hospital
Besançon, 25030, France
Hopital Timone Marseille
Marseille, 13385, France
Hopital Haut-Leveque - CHU Bordeaux
Pessac, 33604, France
Gustave Roussy Cancer Center
Villejuif, 94805, France
ICCRS Candiolo
Candiolo, 10060, Italy
Istituto Clinico Humanitas
Milan, 20072, Italy
Istituto Nazionale Tumori
Milan, 20133, Italy
Vall D'Hebron University Hospital
Barcelona, 08035, Spain
Fundacion Jimenez Diaz University Hospital - Autonomous University of Madrid
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
The Princess Alexandra Hospital NHS Trust (Joanne Kwa, Pharmacist)
Harlow, CM20 1QX, United Kingdom
UCLH Cancer Institute (Meera Desai, Pharmacist)
London, WC1E 6AG, United Kingdom
HCA Healthcare UK
London, WC1E 6JA, United Kingdom