HER2-Positive Advanced Biliary Tract CancerNCT04578444
An Expanded Access Treatment Protocol of Zanidatamab (ZW25) in Patients With HER2-Positive Advanced Biliary Tract Cancer
A study testing Zanidatamab in people with HER2-Positive Advanced Biliary Tract Cancer, run by Jazz Pharmaceuticals at 17 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-Positive Advanced Biliary Tract Cancer
- What is being tested?
- Zanidatamab
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 17 sitesin 5 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
United States4 sites
TOI Clinical Research
Cerritos, California, 90603
NoCo Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Salinas Valley Memorial Healthcare System
Salinas, California, 93901
Washington University School of Medicine
St Louis, Missouri, 63110
France4 sites
Jean Minjoz Hospital
Besançon, 25030
Hopital Timone Marseille
Marseille, 13385
Hopital Haut-Leveque - CHU Bordeaux
Pessac, 33604
Gustave Roussy Cancer Center
Villejuif, 94805
Italy3 sites
ICCRS Candiolo
Candiolo, 10060
Istituto Clinico Humanitas
Milan, 20072
Istituto Nazionale Tumori
Milan, 20133
Spain3 sites
Vall D'Hebron University Hospital
Barcelona, 08035
Fundacion Jimenez Diaz University Hospital - Autonomous University of Madrid
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
United Kingdom3 sites
The Princess Alexandra Hospital NHS Trust (Joanne Kwa, Pharmacist)
Harlow, CM20 1QX
UCLH Cancer Institute (Meera Desai, Pharmacist)
London, WC1E 6AG
HCA Healthcare UK
London, WC1E 6JA
About this study
Official title: 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.
- Being tested
- Zanidatamab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanidatamabDrug
Also called ZW25, ZIIHERA®
Administered intravenously
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-Positive Advanced Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578444
- Sponsor's protocol ID
- ZWI-ZW25-EAP
- Status last verified
- May 2025
- First submitted
- 30 Sep 2020
- Last updated
- 25 May 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Use of Zanidatamab for the Treatment of HER2-Positive Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT04578444
- Acronym / sponsor ID
- ZWI-ZW25-EAP
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZanidatamabAlso: ZW25, ZIIHERA®Administered intravenously | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zanidatamab in people with HER2-Positive Advanced Biliary Tract Cancer, run by Jazz Pharmaceuticals at 17 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, France, Italy, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.