Clinical trial NCT04578444: An Expanded Access Treatment Protocol of Zanidatamab (ZW25) in Patients With HER2-Positive Advanced Biliary Tract Cancer
Official title: Expanded Access Use of Zanidatamab for the Treatment of HER2-Positive Advanced Solid Tumor
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: HER2-Positive Advanced Biliary Tract Cancer
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-10-08
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

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:

    * 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: NoCo Banner MD Anderson Cancer Center
state: Arizona
city: Cerritos
country: United States
facility: TOI Clinical Research
state: California
city: Salinas
country: United States
facility: Salinas Valley Memorial Healthcare System
state: California
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Besançon
country: France
facility: Jean Minjoz Hospital
city: Marseille cedex 5
country: France
facility: Hopital Timone Marseille
city: Pessac
country: France
facility: Hopital Haut-Leveque - CHU Bordeaux
city: Villejuif
country: France
facility: Gustave Roussy Cancer Center
city: Candiolo
country: Italy
facility: ICCRS Candiolo
city: Milano
country: Italy
facility: Istituto Nazionale Tumori
city: Milan
country: Italy
facility: Istituto Clinico Humanitas
city: Barcelona
country: Spain
facility: Vall D'Hebron University Hospital
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz University Hospital - Autonomous University of Madrid
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Harlow
country: United Kingdom
facility: The Princess Alexandra Hospital NHS Trust (Joanne Kwa, Pharmacist)
city: London
country: United Kingdom
facility: UCLH Cancer Institute (Meera Desai, Pharmacist)
city: London
country: United Kingdom
facility: HCA Healthcare UK
Study officials:
References: