A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers (HERIZON-BTC-01)

August 26, 2025 updated by: Jazz Pharmaceuticals

A Phase 2b, Open-label, Single-arm Study of ZW25 Monotherapy in Subjects With Advanced or Metastatic HER2-amplified Biliary Tract Cancers

This multicenter, open-label, single-arm trial will evaluate the anti-tumor activity of ZW25 (zanidatamab) monotherapy in subjects with human epidermal growth factor receptor 2 (HER2)-amplified, inoperable and advanced or metastatic biliary tract cancer (BTC), including intra-hepatic cholangiocarcinoma (ICC), extra-hepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
87

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
No longer available

No longer available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
  • Chile
      • Santiago, Chile, 8330032
        • Centro de Cáncer Nuestra Señora de la Esperanza
      • Temuco, Chile, 645
        • Radiomed (Clinica Alemana de Temuco)
  • China
      • Beijing, China, 100142
        • Beijing Cancer Hospital
      • Beijing, China, 100730
        • Peking Union Medical College Hospital
      • Changchun, China, 130012
        • Jilin Cancer Hospital
      • Changsha, China, 410013
        • Hunan Cancer Hospital
      • Chengdu, China, 610041
        • West China Hospital
      • Guangzhou, China, 510080
        • The First Affiliated Hospital, Sun Yat-sen University
      • Hangzhou, China, 310003
        • The First Affiliated Hospital of Zhejiang University
      • Hangzhou, China, 310014
        • Zhejiang Provincial People's Hospital
      • Hangzhou, China, 310016
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
      • Hangzhou, China, 310022
        • Zhejiang Cancer Hospital
      • Harbin, China, 150081
        • Affiliated Tumor Hospital of Harbin Medical University
      • Hefei, China, 230001
        • Anhui Provincial Hospital
      • Huzhou, China, 313000
        • Huzhou Central Hospital
      • Jinhua, China, 321000
        • Jinhua Central Hospital
      • Lanzhou, China, 730000
        • The First Hospital of Lanzhou University
      • Nanjing, China, 210008
        • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
      • Shandong, China, 250031
        • Shandong Provincial Third Hospital
      • Shanghai, China, 200032
        • Affiliated Zhongshan Hospital of Fudan University
      • Shanghai, China, 200081
        • The Third Affiliated Hospital of the Chinese PLA
      • Tianjin, China, 300060
        • Tianjin Medical University Cancer Institute and Hospital
      • Weifang, China, 261000
        • Weifang People's Hospital
      • Wuhan, China, 430079
        • Hubei Cancer Hospital
      • Zhengzhou, China, 450052
        • The First Affiliated Hospital of Zhengzhou University
  • France
      • Besançon, France, 25030
        • Oncologie médicale Hopital Jean Minjoz
      • Brest, France, 29200
        • Institut de Cancerologie et d'Hematologie Hopital Morvan - CHRU de Brest
      • Marseille, France, 13385
        • Hopitaux de La Timone
      • Poitiers, France, 86000
        • Département Oncologie Gastro-entérologie CHRU de Poitiers La Miletrie
      • Villejuif, France, 94805
        • Département De Médecine
  • Italy
      • Candiolo, Italy, 10060
        • Fondazione del Piemonte per l'Oncologia (IRCCS)
      • Milan, Italy, 20089
        • Istituto Clinico Humanitas
      • Milan, Italy, 20133
        • Istituto Nazionale dei Tumori
      • Padua, Italy, 35128
        • Istituto Oncologico Veneto - I.R.C.C.S.
  • South Korea
      • Jinju, South Korea, 52727
        • Gyeongsang National University Hospital
      • Pusan, South Korea, 49241
        • Pusan National University Hospital
      • Seongnam, South Korea, 13620
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 03722
        • Severance Hospital Yonsei University Health System
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 06591
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center Hospital
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Spain, 08916
        • Universitario Germans Trias i Pujol
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañón
      • Madrid, Spain, 28041
        • Hospital Universitario Doce de Octubre
      • Sabadell, Spain, 08208
        • Corporacio Sanitaria Parc Tauli
      • Zaragoza, Spain, 50009
        • Hospital Miguel Servet
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Royal Free London NHS Foundation Trust
      • London, United Kingdom, W12 0HS
        • Imperial College Healthcare NHS Trust
      • London, United Kingdom, NW1 2PG
        • University College London Hospitals (UCLH)
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Center
      • Tucson, Arizona, United States, 95724
        • University of Arizona Cancer Center
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
      • Santa Monica, California, United States, 90404
        • University of California Los Angeles
      • Whittier, California, United States, 90603
        • The Oncology Institute of Hope and Innovation
    • Florida
      • Orlando, Florida, United States, 32804
        • Advent Health Cancer Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute, Emory University
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Greenebaum Cancer Center
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center - Hospital
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ZW25 (Zanidatamab) Monotherapy
Drug: ZW25 (Zanidatamab)
Administered intravenously
Other Names:
  • ZW25
  • JZP598
  • ZIIHERA®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Confirmed Objective Response Rate (ORR) by Independent Central Review (ICR)
Time Frame: Up to 34 months
Number of participants who achieved a confirmed best overall response (BOR) of either complete response (CR) or partial response (PR) during treatment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response (CR) is defined as a disappearance of all target and non-target lesions and partial response (PR) is defined as at least a 30% decrease in the sum of diameters of all target lesions.
Up to 34 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR) by ICR
Time Frame: Up to 45 months
The time from the first confirmed objective response (CR or PR) to documented progressive disease (PD) per RECIST 1.1, or death from any cause
Up to 45 months
DOR ≥ 16 Weeks by ICR
Time Frame: 24 weeks, up to 45 months
Proportion of subjects with a DOR ≥ 16 weeks per RECIST 1.1
24 weeks, up to 45 months
Disease Control Rate (DCR) by ICR
Time Frame: Up to 45 months
Number of subjects who achieved a best overall response of stable disease (SD), non-CR/non-PD, or confirmed CR or PR per RECIST 1.1
Up to 45 months
Progression-free Survival (PFS) by ICR
Time Frame: Up to 45 months
The time from the first dose of study treatment to the date of documented disease progression (per RECIST 1.1), or death from any cause
Up to 45 months
ORR by Investigator Assessment
Time Frame: Up to 45 months
Number of subjects who achieved a confirmed BOR of either CR or PR during treatment per RECIST 1.1
Up to 45 months
DOR by Investigator Assessment
Time Frame: Up to 45 months
The time from the first confirmed objective response (CR or PR) to documented progressive disease (PD) per RECIST 1.1, or death from any cause
Up to 45 months
DOR ≥ 16 Weeks by Investigator Assessment
Time Frame: 24 weeks, up to 45 months
Proportion of subjects with a DOR ≥ 16 weeks per RECIST 1.1
24 weeks, up to 45 months
DCR by Investigator Assessment
Time Frame: Up to 45 months
Number of subjects who achieved a best overall response of stable disease (SD), non-CR/non-PD, or confirmed CR or PR per RECIST 1.1
Up to 45 months
PFS by Investigator Assessment
Time Frame: Up to 45 months
The time from the first dose of study treatment to the date of documented disease progression (per RECIST 1.1), or death from any cause
Up to 45 months
Overall Survival
Time Frame: Up to 45 months
The time from the first dose of study treatment until the date of death from any cause
Up to 45 months
Incidence of Adverse Events (AEs)
Time Frame: Up to 45 months
Number of subjects who experienced AEs or serious adverse events
Up to 45 months
Incidence of Laboratory Abnormalities
Time Frame: Up to 45 months
Number of subjects who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology or chemistry. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
Up to 45 months
Maximum Serum Concentration of ZW25
Time Frame: Pre-dose, end of infusion, 2, 4, 8, 24 and 96 hours post dose
Pre-dose, end of infusion, 2, 4, 8, 24 and 96 hours post dose
Trough Concentration of ZW25
Time Frame: Pre-dose, end of infusion, 2, 4, 8, 24 and 96 hours post dose
Minimum observed serum concentration (trough)
Pre-dose, end of infusion, 2, 4, 8, 24 and 96 hours post dose
Incidence of Anti-drug Antibodies (ADAs)
Time Frame: Up to 45 months
Number of subjects who develop ADAs
Up to 45 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jazz Pharmaceuticals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
BeiGene
Jazz Pharmaceuticals Ireland Limited
BeOne Medicines LTD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Phillip Garfin, MD, PhD, Zymeworks Inc.
  • Study Director: Jiafang Ma, MD, BeiGene, Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 11, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZWI-ZW25-203
  • 2020-000459-11 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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