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

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.

Study Overview

• Status: Available
• Conditions: HER2-Positive Advanced Biliary Tract Cancer
• Intervention / Treatment: Drug: Zanidatamab

• Study Type: Expanded Access
• Expanded Access Type: Intermediate-size Population

Contacts and Locations

• Study Contact: Name: Early Access Care; Phone Number: 203-441-7938; Email: Zymeworks.EAP@earlyaccesscare.com
• Study Contact Backup: Name: Clinical Trial Disclosure & Transparency; Phone Number: 215-832-3750; Email: ClinicalTrialDisclosure@JazzPharma.com

Study Locations

• France
  • Besançon, France, 25030
    • Available
    • Jean Minjoz Hospital
  • Marseille cedex 5, France, 13385
    • Available
    • Hopital Timone Marseille
  • Pessac, France, 33604
    • Available
    • Hopital Haut-Leveque - CHU Bordeaux
  • Villejuif, France, 94805
    • Available
    • Gustave Roussy Cancer Center
• Italy
  • Candiolo, Italy, 10060
    • Available
    • ICCRS Candiolo
  • Milan, Italy, 20072
    • Available
    • Istituto Clinico Humanitas
  • Milano, Italy, 20133
    • Available
    • Istituto Nazionale Tumori
• Spain
  • Barcelona, Spain, 08035
    • Available
    • Vall D'Hebron University Hospital
  • Madrid, Spain, 28041
    • Available
    • Hospital Universitario 12 De Octubre
  • Madrid, Spain, 28040
    • Available
    • Fundacion Jimenez Diaz University Hospital - Autonomous University of Madrid
• United Kingdom
  • Harlow, United Kingdom, CM20 1QX
    • Available
    • The Princess Alexandra Hospital NHS Trust (Joanne Kwa, Pharmacist)
  • London, United Kingdom, WC1E 6AG
    • Available
    • UCLH Cancer Institute (Meera Desai, Pharmacist)
  • London, United Kingdom, WC1E 6JA
    • Available
    • HCA Healthcare UK
• United States
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Available
      • NoCo Banner MD Anderson Cancer Center
  • California
    • Cerritos, California, United States, 90603
      • Available
      • TOI Clinical Research
    • Salinas, California, United States, 93901
      • Available
      • Salinas Valley Memorial Healthcare System
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Available
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Jazz Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: December 7, 2022
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Estimated): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Biliary Tract Diseases; Biliary Tract Neoplasms
• Other Study ID Numbers: ZWI-ZW25-EAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No