<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/NCT04446260</url>
  </required_header>
  <id_info>
    <org_study_id>SHR-A1811-I-101</org_study_id>
    <nct_id>NCT04446260</nct_id>
  </id_info>
  <brief_title>A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors</brief_title>
  <official_title>A Phase 1 Multi-Country, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A1811 in HER2 Expressing or Mutated Advanced Malignant Solid Tumor Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu HengRui Medicine Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Atridia Pty Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Jiangsu HengRui Medicine Co., Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics&#xD;
      and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2 expressing or&#xD;
      mutated advanced malignant solid tumor subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 3, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence and severity of adverse events (AEs)</measure>
    <time_frame>From Day1 to 90 days after last dose</time_frame>
    <description>Frequency and seriousness of treatment emergent adverse events (TEAEs)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PK parameter: Tmax of SHR-A1811</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Time to maximal concentration (Tmax) of SHR-A1811</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK parameter: Cmax of SHR-A1811</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Maximal concentration (Cmax) of SHR-A1811</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK parameter: AUC0-t of SHR-A1811</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>AUC computed from time zero to the time of the last quantifiable concentration (AUC0-t) of SHR-A1811</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity of SHR-A1811</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Including anti-drug antibody and/or neutralizing antibody</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor response using RECIST 1.1</measure>
    <time_frame>From first dose to disease progression or death, whichever comes first, up to 30 months</time_frame>
    <description>RECIST=Response Evaluation Criteria in Solid Tumors Assessment of tumor response until disease progression or death to evaluate the efficacy of SHR-A1811 up to 30 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">226</enrollment>
  <condition>Advanced Solid Tumors</condition>
  <arm_group>
    <arm_group_label>Part 1 Dose escalation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 Indication expansion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SHR-A1811</intervention_name>
    <description>be administered via intravenous (IV) infusion</description>
    <arm_group_label>Part 1 Dose escalation</arm_group_label>
    <arm_group_label>Part 2 Indication expansion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Advanced/unresectable or metastatic solid tumor with HER2 expression or mutation that&#xD;
             is refractory to or intolerable with standard treatment, or for which no standard&#xD;
             treatment is available&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1&#xD;
&#xD;
          -  LVEF ≥ 50% by either ECHO or MUGA&#xD;
&#xD;
          -  Has adequate renal and hepatic function&#xD;
&#xD;
          -  Female subjects agree not to be pregnant or lactating from beginning of the study&#xD;
             screening until 6 months after receiving the last treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of clinically significant lung diseases (e.g., interstitial pneumonia,&#xD;
             pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or suspected to&#xD;
             have these diseases by imaging at screening period&#xD;
&#xD;
          -  Known hereditary or acquired bleeding and thrombotic tendency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sherry Zhu, MD, PhD</last_name>
    <phone>+86 021-61053363</phone>
    <email>xiaoyu.zhu@hengrui.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Catherine Rong</last_name>
    <phone>+86 021-61053363</phone>
    <email>shangyi.rong@hengrui.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Montefiore-Einstein Center for Cancer Care</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andreas Kaubisch</last_name>
      <phone>718-920-4826</phone>
      <email>Akaubisc@montefiore.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Gabrail Cancer Center</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44718</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Greenville Hospital System</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Ki Chung</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Prisma-Health Cancer Institute</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Mary Crowley Cancer Research</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Minal Barve</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Center for Oncology and Blood Disorders</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Macquarie University Hospital</name>
      <address>
        <city>Macquarie</city>
        <state>New South Wales</state>
        <zip>2109</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>John Park</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Southern Oncology Clinical Research Unit</name>
      <address>
        <city>Bedford Park</city>
        <state>South Australia</state>
        <zip>5042</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Amitesh Roy</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Peninsula and South Eastern Haematology &amp; Oncology Group</name>
      <address>
        <city>Frankston</city>
        <state>Victoria</state>
        <zip>3199</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Vinod Ganju</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nucleus Network</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Alfred Hospital</name>
      <address>
        <city>Melbourne</city>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Mark Voskoboynik</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The first affiliated hospital of bengbu medical college</name>
      <address>
        <city>Bengbu</city>
        <state>Anhui</state>
        <zip>233000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cancer Hospital Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nanfang Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sun Yat-Sen Memorial Hospital, Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Henan cancer Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Zhongnan hospital of Wuhan university</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430062</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hubei cancer hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430079</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Xiangya hospital central south university</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410008</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hunan cancer hospital</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410031</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nanjing Drum Tower Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210008</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Jilin University</name>
      <address>
        <city>Changchuan</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Shengjing Hospital of China medical university</name>
      <address>
        <city>Shengyang</city>
        <state>Liaoning</state>
        <zip>110022</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fudan University Shanghai cancer center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fudan Unversity Zhongshan Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sichuan Cancer Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610042</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tianjin medical university cancer institute&amp;hoospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300181</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The second affiliated hospital Zhejiang university school of medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310014</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Zhejiang provincial people's hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310014</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <state>Gyeonggi-do</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>3080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>5505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <zip>70457</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Chia-Jui Yen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital, Linkou</name>
      <address>
        <city>Taoyuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>China</country>
    <country>Korea, Republic of</country>
    <country>Taiwan</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>July 19, 2023</last_update_submitted>
  <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT04446260
org study id: SHR-A1811-I-101
nct id: NCT04446260
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics
      and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2 expressing or
      mutated advanced malignant solid tumor subjects.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence and severity of adverse events (AEs)
time frame: From Day1 to 90 days after last dose
description: Frequency and seriousness of treatment emergent adverse events (TEAEs)
measure: PK parameter: Tmax of SHR-A1811
time frame: Through study completion, an average of 1 year
description: Time to maximal concentration (Tmax) of SHR-A1811
measure: PK parameter: Cmax of SHR-A1811
time frame: Through study completion, an average of 1 year
description: Maximal concentration (Cmax) of SHR-A1811
measure: PK parameter: AUC0-t of SHR-A1811
time frame: Through study completion, an average of 1 year
description: AUC computed from time zero to the time of the last quantifiable concentration (AUC0-t) of SHR-A1811
measure: Immunogenicity of SHR-A1811
time frame: Through study completion, an average of 1 year
description: Including anti-drug antibody and/or neutralizing antibody
measure: Tumor response using RECIST 1.1
time frame: From first dose to disease progression or death, whichever comes first, up to 30 months
description: RECIST=Response Evaluation Criteria in Solid Tumors Assessment of tumor response until disease progression or death to evaluate the efficacy of SHR-A1811 up to 30 months
arm group label: Part 1 Dose escalation
arm group type: Experimental
arm group label: Part 2 Indication expansion
arm group type: Experimental
intervention type: Drug
intervention name: SHR-A1811
description: be administered via intravenous (IV) infusion
arm group label: Part 1 Dose escalation
arm group label: Part 2 Indication expansion
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sherry Zhu, MD, PhD
phone: +86 021-61053363
email: xiaoyu.zhu@hengrui.com
last name: Catherine Rong
phone: +86 021-61053363
email: shangyi.rong@hengrui.com
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
investigator: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
country: Australia
country: China
country: Korea, Republic of
country: Taiwan
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: No