<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04466891</url>
  </required_header>
  <id_info>
    <org_study_id>ZWI-ZW25-203</org_study_id>
    <secondary_id>2020-000459-11</secondary_id>
    <nct_id>NCT04466891</nct_id>
  </id_info>
  <brief_title>A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers</brief_title>
  <acronym>HERIZON-BTC-01</acronym>
  <official_title>A Phase 2b, Open-label, Single-arm Study of ZW25 Monotherapy in Subjects With Advanced or Metastatic HER2-amplified Biliary Tract Cancers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jazz Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>BeiGene, Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jazz Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This multicenter, open-label, single-arm trial will evaluate the anti-tumor activity of ZW25&#xD;
      (zanidatamab) monotherapy in subjects with human epidermal growth factor receptor 2&#xD;
      (HER2)-amplified, inoperable and advanced or metastatic biliary tract cancer (BTC), including&#xD;
      intra-hepatic cholangiocarcinoma (ICC), extra-hepatic cholangiocarcinoma (ECC), and&#xD;
      gallbladder cancer (GBC).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Anticipated">October 31, 2024</completion_date>
  <primary_completion_date type="Actual">July 28, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>Yes</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>single-arm, open-label, multi-cohort, multicenter study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Confirmed objective response rate (ORR) by independent central review (ICR)</measure>
    <time_frame>Up to 2.5 years</time_frame>
    <description>Number of subjects 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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DOR) by ICR</measure>
    <time_frame>Up to 2.5 years</time_frame>
    <description>The time from the first objective response (CR or PR) to documented progressive disease (PD) per RECIST 1.1, clinical progression, or death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DOR at ≥ 16 weeks by ICR</measure>
    <time_frame>24 weeks to 2.5 years</time_frame>
    <description>Proportion of subjects with a DOR ≥ 16 weeks per RECIST 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate (DCR) by ICR</measure>
    <time_frame>Up to 2.5 years</time_frame>
    <description>Number of subjects who achieved a best response of CR, PR, or stable disease (SD) during treatment per RECIST 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS) by ICR</measure>
    <time_frame>Up to 2.5 years</time_frame>
    <description>The time from the first dose of study treatment to the date of documented disease progression (per RECIST 1.1), clinical progression, or death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ORR by investigator assessment</measure>
    <time_frame>Up to 2.5 years</time_frame>
    <description>Number of subjects who achieved a BOR of either CR or PR during treatment per RECIST 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DOR by investigator assessment</measure>
    <time_frame>Up to 2.5 years</time_frame>
    <description>The time from the first objective response (CR or PR) to documented PD per RECIST 1.1, clinical progression, or death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DOR at ≥ 16 weeks by investigator assessment</measure>
    <time_frame>24 weeks to 2.5 years</time_frame>
    <description>Proportion of subjects with a DOR ≥ 16 weeks per RECIST 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DCR by investigator assessment</measure>
    <time_frame>Up to 2.5 years</time_frame>
    <description>Number of subjects who achieved a best response of CR, PR, or SD during treatment per RECIST 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFS by investigator assessment</measure>
    <time_frame>Up to 2.5 years</time_frame>
    <description>The time from the first dose of study treatment to the date of documented disease progression (per RECIST 1.1), clinical progression, or death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Up to 2.5 years</time_frame>
    <description>The time from the first dose of study treatment until the date of death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events (AEs)</measure>
    <time_frame>Up to 2.5 years</time_frame>
    <description>Number of subjects who experienced AEs or serious adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of laboratory abnormalities</measure>
    <time_frame>Up to 2.5 years</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum serum concentration of ZW25</measure>
    <time_frame>Up to 2.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trough concentration of ZW25</measure>
    <time_frame>Up to 2.5 years</time_frame>
    <description>Minimum observed serum concentration (trough)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of anti-drug antibodies (ADAs)</measure>
    <time_frame>Up to 2.5 years</time_frame>
    <description>Number of subjects who develop ADAs</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">87</enrollment>
  <condition>HER2-amplified Biliary Tract Cancers</condition>
  <arm_group>
    <arm_group_label>ZW25 (Zanidatamab) Monotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ZW25 (Zanidatamab)</intervention_name>
    <description>Administered intravenously</description>
    <arm_group_label>ZW25 (Zanidatamab) Monotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>In situ hybridization (ISH)-based companion diagnostic assay</intervention_name>
    <description>Subjects will be tested for HER2 gene-amplification using the ISH-based companion diagnostic assay</description>
    <arm_group_label>ZW25 (Zanidatamab) Monotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Immunohistochemistry (IHC)-based companion diagnostic assay</intervention_name>
    <description>Subjects will be tested for HER2 protein-expression using the IHC-based companion diagnostic assay</description>
    <arm_group_label>ZW25 (Zanidatamab) Monotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically- or cytologically-confirmed BTC, including ICC, ECC or GBC.&#xD;
&#xD;
          -  Locally advanced or metastatic BTC and not eligible for curative resection,&#xD;
             transplantation, or ablative therapies.&#xD;
&#xD;
          -  Received at least 1 prior gemcitabine-containing systemic chemotherapy regimen for&#xD;
             advanced disease, and experienced disease progression after or developed intolerance&#xD;
             to the most recent prior therapy. For subjects who received gemcitabine in prior&#xD;
             adjuvant or neoadjuvant treatment, if progression occurred &lt; 6 months from the latter&#xD;
             of primary surgical resection or completion of gemcitabine-containing adjuvant&#xD;
             therapy, they will be considered as having received 1 prior line of therapy for&#xD;
             advanced disease.&#xD;
&#xD;
          -  Subjects must test positive for HER2 amplification by ISH-assay at a central&#xD;
             laboratory on a new biopsy or archival tissue. Note that fine needle aspirates (FNAs;&#xD;
             cytology samples) and biopsies from sites of bone metastases are not acceptable.&#xD;
             Testing may occur at any time after diagnosis of advanced or metastatic disease and&#xD;
             before study enrollment.&#xD;
&#xD;
          -  Male or female, ≥18 years of age (or the legal age of adulthood per country-specific&#xD;
             regulations).&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.&#xD;
&#xD;
          -  Adequate organ function.&#xD;
&#xD;
          -  Adequate cardiac function, as defined by left ventricular ejection fraction ≥ 50%.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Received systemic anti-cancer therapy within 3 weeks of the first dose of ZW25.&#xD;
             Received radiotherapy within 2 weeks of the first dose of ZW25.&#xD;
&#xD;
          -  Prior treatment with HER2-targeted agents.&#xD;
&#xD;
          -  Untreated central nervous system (CNS) metastases, symptomatic CNS metastases, or&#xD;
             radiation treatment for CNS metastases within 4 weeks of start of study treatment.&#xD;
             Stable, treated brain metastases are allowed (defined as subjects who are off steroids&#xD;
             and anticonvulsants and are neurologically stable with no evidence of radiographic&#xD;
             progression for at least 4 weeks at the time of screening).&#xD;
&#xD;
          -  Known leptomeningeal disease (LMD). If LMD has been reported radiographically on&#xD;
             baseline MRI, but is not suspected clinically by the investigator, the subject must be&#xD;
             free of neurological symptoms of LMD.&#xD;
&#xD;
          -  Concurrent uncontrolled or active hepatobiliary disorders or untreated or ongoing&#xD;
             complications after laparoscopic procedures or stent placement, including but not&#xD;
             limited to active cholangitis, unresolved biliary obstruction, infected biloma or&#xD;
             abscess. Any complications must be resolved more than 2 weeks prior to the first dose&#xD;
             of ZW25.&#xD;
&#xD;
          -  Prior or concurrent malignancy whose natural history or treatment has, in the opinion&#xD;
             of the investigator or medical monitor, the potential to interfere with the safety or&#xD;
             efficacy assessment of the investigational regimen.&#xD;
&#xD;
          -  Active hepatitis&#xD;
&#xD;
          -  Infection with human immunodeficiency virus (HIV)-1 or HIV-2&#xD;
&#xD;
          -  QTc Fridericia (QTcF) &gt; 470 ms.&#xD;
&#xD;
          -  History of myocardial infarction or unstable angina within 6 months prior to&#xD;
             enrollment, troponin levels consistent with myocardial infarction, or clinically&#xD;
             significant cardiac disease.&#xD;
&#xD;
          -  Acute or chronic uncontrolled pancreatitis or Child-Pugh Class C liver disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Banner MD Anderson</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Arizona Cancer Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>95724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City of Hope National Medical Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Los Angeles</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Oncology Institute of Hope and Innovation</name>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <zip>90603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advent Health Cancer Institute</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Winship Cancer Institute, Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322-1013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland Greenebaum Cancer Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center - Hospital</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390-9129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Cancer Care Alliance</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pontificia Universidad Catolica de Chile</name>
      <address>
        <city>Santiago</city>
        <zip>8330032</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiomed (Clinica Alemana de Temuco)</name>
      <address>
        <city>Temuco</city>
        <zip>645</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jilin Cancer Hospital</name>
      <address>
        <city>Changchun</city>
        <zip>130012</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hunan Cancer Hospital</name>
      <address>
        <city>Changsha</city>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital</name>
      <address>
        <city>Chengdu</city>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital, Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhejiang Provincial People's Hospital</name>
      <address>
        <city>Hangzhou</city>
        <zip>310014</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Run Run Shaw Hospital, Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <zip>310016</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affiliated Tumor Hospital of Harbin Medical University</name>
      <address>
        <city>Harbin</city>
        <zip>150081</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anhui Provincial Hospital</name>
      <address>
        <city>Hefei</city>
        <zip>230001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huzhou Central Hospital</name>
      <address>
        <city>Huzhou</city>
        <zip>313000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jinhua Central Hospital</name>
      <address>
        <city>Jinhua</city>
        <zip>321000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital Of Lanzhou University</name>
      <address>
        <city>Lanzhou</city>
        <zip>730000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School</name>
      <address>
        <city>Nanjing</city>
        <zip>210008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shandong Provincial Third Hospital</name>
      <address>
        <city>Shandong</city>
        <zip>250031</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affiliated Zhongshan Hospital of Fudan University</name>
      <address>
        <city>Shanghai</city>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Third Affiliated Hospital of the Chinese PLA</name>
      <address>
        <city>Shanghai</city>
        <zip>200081</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University Cancer Institute and Hospital</name>
      <address>
        <city>Tianjin</city>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weifang People's Hospital</name>
      <address>
        <city>Weifang</city>
        <zip>261000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hubei Cancer Hospital</name>
      <address>
        <city>Wuhan</city>
        <zip>430079</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <zip>450052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncologie médicale Hopital Jean Minjoz</name>
      <address>
        <city>Besançon</city>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de Cancerologie et d'Hematologie Hopital Morvan - CHRU de Brest</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopitaux de La Timone</name>
      <address>
        <city>Marseille</city>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Département Oncologie Gastro-entérologie CHRU de Poitiers La Miletrie</name>
      <address>
        <city>Poitiers</city>
        <zip>86000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Département De Médecine</name>
      <address>
        <city>Villejuif</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione del Piemonte per l'Oncologia (IRCCS)</name>
      <address>
        <city>Candiolo</city>
        <zip>10060</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Nazionale Dei Tumori</name>
      <address>
        <city>Milano</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Clinico Humanitas</name>
      <address>
        <city>Milan</city>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Oncologico Veneto - I.R.C.C.S.</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gyeongsang National University Hospital</name>
      <address>
        <city>Jinju-si</city>
        <zip>52727</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pusan National University Hospital</name>
      <address>
        <city>Pusan</city>
        <zip>49241</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital Yonsei University Health System</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitario Germans Trias i Pujol</name>
      <address>
        <city>Barcelona</city>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Reina Sofia</name>
      <address>
        <city>Cordoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Marañón</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Doce de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Parc Tauli de Sabadell</name>
      <address>
        <city>Sabadell</city>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College London Hospitals (UCLH)</name>
      <address>
        <city>London</city>
        <zip>NW1 2PG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Free London NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imperial College Healthcare NHS Trust</name>
      <address>
        <city>London</city>
        <zip>W12 0HS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Chile</country>
    <country>China</country>
    <country>France</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>August 24, 2023</last_update_submitted>
  <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HER2</keyword>
  <keyword>Bispecific antibody</keyword>
  <keyword>Biparatopic antibody</keyword>
  <keyword>Immunotherapy</keyword>
  <keyword>Biliary Tract Cancer</keyword>
  <keyword>Intra-hepatic cholangiocarcinoma</keyword>
  <keyword>Extra-hepatic cholangiocarcinoma</keyword>
  <keyword>Gallbladder cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Biliary Tract Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04466891
org study id: ZWI-ZW25-203
secondary id: 2020-000459-11
nct id: NCT04466891
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: Yes
is unapproved device: Yes
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).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: single-arm, open-label, multi-cohort, multicenter study
primary purpose: Treatment
masking: None (Open Label)
measure: Confirmed objective response rate (ORR) by independent central review (ICR)
time frame: Up to 2.5 years
description: Number of subjects 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
measure: Duration of response (DOR) by ICR
time frame: Up to 2.5 years
description: The time from the first objective response (CR or PR) to documented progressive disease (PD) per RECIST 1.1, clinical progression, or death from any cause
measure: DOR at ≥ 16 weeks by ICR
time frame: 24 weeks to 2.5 years
description: Proportion of subjects with a DOR ≥ 16 weeks per RECIST 1.1
measure: Disease control rate (DCR) by ICR
time frame: Up to 2.5 years
description: Number of subjects who achieved a best response of CR, PR, or stable disease (SD) during treatment per RECIST 1.1
measure: Progression-free survival (PFS) by ICR
time frame: Up to 2.5 years
description: The time from the first dose of study treatment to the date of documented disease progression (per RECIST 1.1), clinical progression, or death from any cause
measure: ORR by investigator assessment
time frame: Up to 2.5 years
description: Number of subjects who achieved a BOR of either CR or PR during treatment per RECIST 1.1
measure: DOR by investigator assessment
time frame: Up to 2.5 years
description: The time from the first objective response (CR or PR) to documented PD per RECIST 1.1, clinical progression, or death from any cause
measure: DOR at ≥ 16 weeks by investigator assessment
time frame: 24 weeks to 2.5 years
description: Proportion of subjects with a DOR ≥ 16 weeks per RECIST 1.1
measure: DCR by investigator assessment
time frame: Up to 2.5 years
description: Number of subjects who achieved a best response of CR, PR, or SD during treatment per RECIST 1.1
measure: PFS by investigator assessment
time frame: Up to 2.5 years
description: The time from the first dose of study treatment to the date of documented disease progression (per RECIST 1.1), clinical progression, or death from any cause
measure: Overall survival
time frame: Up to 2.5 years
description: The time from the first dose of study treatment until the date of death from any cause
measure: Incidence of adverse events (AEs)
time frame: Up to 2.5 years
description: Number of subjects who experienced AEs or serious adverse events
measure: Incidence of laboratory abnormalities
time frame: Up to 2.5 years
description: 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
measure: Maximum serum concentration of ZW25
time frame: Up to 2.5 years
measure: Trough concentration of ZW25
time frame: Up to 2.5 years
description: Minimum observed serum concentration (trough)
measure: Incidence of anti-drug antibodies (ADAs)
time frame: Up to 2.5 years
description: Number of subjects who develop ADAs
arm group label: ZW25 (Zanidatamab) Monotherapy
arm group type: Experimental
intervention type: Drug
intervention name: ZW25 (Zanidatamab)
description: Administered intravenously
arm group label: ZW25 (Zanidatamab) Monotherapy
intervention type: Diagnostic Test
intervention name: In situ hybridization (ISH)-based companion diagnostic assay
description: Subjects will be tested for HER2 gene-amplification using the ISH-based companion diagnostic assay
arm group label: ZW25 (Zanidatamab) Monotherapy
intervention type: Diagnostic Test
intervention name: Immunohistochemistry (IHC)-based companion diagnostic assay
description: Subjects will be tested for HER2 protein-expression using the IHC-based companion diagnostic assay
arm group label: ZW25 (Zanidatamab) Monotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Canada
country: Chile
country: China
country: France
country: Italy
country: Korea, Republic of
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Biliary Tract Neoplasms
sharing ipd: No