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New drug ZW25 shows promise for rare bile duct cancer

NCT ID NCT04466891

Disease control Sponsor: Jazz Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a drug called ZW25 (zanidatamab) in 87 people with advanced or metastatic HER2-amplified biliary tract cancer that had worsened after standard chemotherapy. The goal was to see if the drug could shrink tumors and how long that effect lasted. The trial is now complete, and results will help determine if ZW25 could become a new treatment option for this hard-to-treat cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Zanidatamab (ZW25)
What this could lead to
If successful, this could provide a new targeted treatment option for people with HER2-positive biliary tract cancer who have few alternatives.
What could go wrong
This is a single-arm, phase 2 study with only 87 participants, so results are preliminary. The drug may not work for everyone and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

87 people

The number who actually took part.

Started

Oct 2020

Finished

Jul 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically- or cytologically-confirmed BTC, including ICC, ECC or GBC. * Locally advanced or metastatic BTC and not eligible for curative resection, transplantation, or ablative therapies. * Received at least 1 prior gemcitabine-containing systemic chemotherapy regimen for advanced disease, and experienced disease progression after or developed intolerance to the most recent prior therapy. For subjects who received gemcitabine in prior adjuvant or neoadjuvant treatment, if progression occurred \< 6 months from the latter of primary surgical resection or completion of gemcitabine-containing adjuvant therapy, they will be considered as having received 1 prior line of therapy for advanced disease. * Subjects must test positive for HER2 amplification by ISH-assay at a central laboratory on a new biopsy or archival tissue. Note that fine needle aspirates (FNAs; cytology samples) and biopsies from sites of bone metastases are not acceptable. Testing may occur at any time after diagnosis of advanced or metastatic disease and before study enrollment. * Male or female, ≥18 years of age (or the legal age of adulthood per country-specific regulations). * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. * Adequate organ function. * Adequate cardiac function, as defined by left ventricular ejection fraction ≥ 50%. Exclusion Criteria: * Received systemic anti-cancer therapy within 3 weeks of the first dose of ZW25. Received radiotherapy within 2 weeks of the first dose of ZW25. * Prior treatment with HER2-targeted agents. * Untreated central nervous system (CNS) metastases, symptomatic CNS metastases, or radiation treatment for CNS metastases within 4 weeks of start of study treatment. Stable, treated brain metastases are allowed (defined as subjects 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). * Known leptomeningeal disease (LMD). If LMD has been reported radiographically on baseline MRI, but is not suspected clinically by the investigator, the subject must be free of neurological symptoms of LMD. * 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, infected biloma or abscess. Any complications must be resolved more than 2 weeks prior to the first dose of ZW25. * Prior or concurrent malignancy whose natural history or treatment has, in the opinion of the investigator or medical monitor, the potential to interfere with the safety or efficacy assessment of the investigational regimen. * Active hepatitis * Infection with human immunodeficiency virus (HIV)-1 or HIV-2 * QTc Fridericia (QTcF) \> 470 ms. * History of myocardial infarction or unstable angina within 6 months prior to enrollment, troponin levels consistent with myocardial infarction, or clinically significant cardiac disease. * Acute or chronic uncontrolled pancreatitis or Child-Pugh Class C liver disease.

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Conditions

The condition(s) this trial relates to.

biliary tract cancer Biliary Tract Neoplasms extrahepatic bile duct carcinoma gallbladder cancer gallbladder neoplasm intrahepatic cholangiocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HER2-amplified biliary tract cancers

Contacts and locations

Locations

  • Advent Health Cancer Institute

    Orlando, Florida, 32804, United States

  • Affiliated Tumor Hospital of Harbin Medical University

    Harbin, 150081, China

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, 200032, China

  • Anhui Provincial Hospital

    Hefei, 230001, China

  • Asan Medical Center Hospital

    Seoul, 05505, South Korea

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Beijing Cancer Hospital

    Beijing, 100142, China

  • Centro de Cáncer Nuestra Señora de la Esperanza

    Santiago, 8330032, Chile

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • Corporacio Sanitaria Parc Tauli

    Sabadell, 08208, Spain

  • Département De Médecine

    Villejuif, 94805, France

  • Département Oncologie Gastro-entérologie CHRU de Poitiers La Miletrie

    Poitiers, 86000, France

  • Fondazione del Piemonte per l'Oncologia (IRCCS)

    Candiolo, 10060, Italy

  • Gyeongsang National University Hospital

    Jinju, 52727, South Korea

  • Hopitaux de La Timone

    Marseille, 13385, France

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007, Spain

  • Hospital Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Doce de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, 14004, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hubei Cancer Hospital

    Wuhan, 430079, China

  • Hunan Cancer Hospital

    Changsha, 410013, China

  • Huzhou Central Hospital

    Huzhou, 313000, China

  • Imperial College Healthcare NHS Trust

    London, W12 0HS, United Kingdom

  • Institut de Cancerologie et d'Hematologie Hopital Morvan - CHRU de Brest

    Brest, 29200, France

  • Istituto Clinico Humanitas

    Milan, 20089, Italy

  • Istituto Nazionale Dei Tumori

    Milan, 20133, Italy

  • Istituto Oncologico Veneto - I.R.C.C.S.

    Padova, 35128, Italy

  • Jilin Cancer Hospital

    Changchun, 130012, China

  • Jinhua Central Hospital

    Jinhua, 321000, China

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

    Nanjing, 210008, China

  • Oncologie médicale Hopital Jean Minjoz

    Besançon, 25030, France

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Peking Union Medical College Hospital

    Beijing, 100730, China

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9, Canada

  • Pusan National University Hospital

    Pusan, 49241, South Korea

  • Radiomed (Clinica Alemana de Temuco)

    Temuco, 645, Chile

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG, United Kingdom

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109, United States

  • Seoul National University Bundang Hospital

    Seongnam, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Shandong Provincial Third Hospital

    Shandong, 250031, China

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, 310016, China

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591, South Korea

  • The First Affiliated Hospital of Zhejiang University

    Hangzhou, 310003, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450052, China

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, 510080, China

  • The First Hospital Of Lanzhou University

    Lanzhou, 730000, China

  • The Oncology Institute of Hope and Innovation

    Whittier, California, 90603, United States

  • The Third Affiliated Hospital of the Chinese PLA

    Shanghai, 200081, China

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, 300060, China

  • Universitario Germans Trias i Pujol

    Barcelona, 08916, Spain

  • University College London Hospitals (UCLH)

    London, NW1 2PG, United Kingdom

  • University of Arizona Cancer Center

    Tucson, Arizona, 95724, United States

  • University of California Los Angeles

    Santa Monica, California, 90404, United States

  • University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland, 21201, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Texas Southwestern Medical Center - Hospital

    Dallas, Texas, 75390, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Weifang People's Hospital

    Weifang, 261000, China

  • West China Hospital

    Chengdu, 610041, China

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322, United States

  • Zhejiang Cancer Hospital

    Hangzhou, 310022, China

  • Zhejiang Provincial People's Hospital

    Hangzhou, 310014, China

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