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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.
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Inclusion criteria
Exclusion criteria
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:
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
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Early Access Care; Clinical Trial Disclosure & Transparency
Data sourced from clinicaltrials.gov
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