<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/NCT04469725</url>
  </required_header>
  <id_info>
    <org_study_id>KN046-205</org_study_id>
    <nct_id>NCT04469725</nct_id>
  </id_info>
  <brief_title>KN046 (a Humanized PD-L1/CTLA4 Bispecific Single Domain Fc Fusion Protein Antibody) in Subjects With Thymic Carcinoma</brief_title>
  <official_title>A Phase 2, Open-Label, Multi-Center Study to Evaluate Efficacy, Safety and Tolerability of KN046 in Subjects With Thymic Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu Alphamab Biopharmaceuticals Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu Alphamab Biopharmaceuticals Co., Ltd</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 2, open-label, multi-center, single arm study in subjects with advanced&#xD;
      thymic carcinoma after failure of platinum-based combination chemotherapy. Subjects should&#xD;
      have documented progressive disease while on platinum-based combination chemotherapy. If&#xD;
      subjects discontinued platinum-based therapy due to reasons other than progressive disease,&#xD;
      subjects should have completed at least 2 cycles of platinum-based combination chemotherapy&#xD;
      before the commencement of documented progressive disease. Subjects will be treated with&#xD;
      KN046 5 milligram per kilogram every 2 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 2, 2020</start_date>
  <completion_date type="Anticipated">August 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>subjects enrolled receive KN046</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ORR</measure>
    <time_frame>up to 2 years</time_frame>
    <description>ORR (best overall response) per RECIST v1.1 calculated as the proportion of subjects with a best overall response defined as confirmed complete response or confirmed partial response (CR+PR) by Independent Review Committee;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DOR</measure>
    <time_frame>up to 3 years</time_frame>
    <description>DOR (duration of response), calculated as the time from the date of the first documented CR or PR to the first documented progression or death due to underlying cancer;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DCR</measure>
    <time_frame>up to 3 years</time_frame>
    <description>DCR (disease control rate), calculated as the proportion of subjects with best overall response of CR, PR, or SD (stable disease);</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CBR</measure>
    <time_frame>up to 3 years</time_frame>
    <description>CBR (clinical benefit rate), calculated as the proportion of subjects with best overall response of CR, PR, or SD on at least 24 weeks;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFS</measure>
    <time_frame>up to 3 years</time_frame>
    <description>PFS (progression free survival), defined as time from first dose of trial treatment to progression or death due to any cause;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TTR</measure>
    <time_frame>up to 3 years</time_frame>
    <description>TTR (time to response), calculated as the time from first dose of trial treatment to first documented response (CR+PR);</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">66</enrollment>
  <condition>Thymic Carcinoma</condition>
  <arm_group>
    <arm_group_label>Thymic carcinoma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>enrolled subjects will receive KN046 every 2 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KN046</intervention_name>
    <description>KN046 5 milligram per kilogram, every 2 weeks</description>
    <arm_group_label>Thymic carcinoma</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Male or female, ≥18 years&#xD;
&#xD;
          -  Pathologically confirmed diagnosis of thymic carcinoma&#xD;
&#xD;
          -  Inoperable or metastatic disease&#xD;
&#xD;
          -  Had failed at least one regimen containing platinum-based combination chemotherapy for&#xD;
             locally advanced unresectable or metastatic disease&#xD;
&#xD;
          -  Baseline measurable disease&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Thymomas, thymolipoma, germ cell tumors, teratomas, seminomas&#xD;
&#xD;
          -  Leptomeningeal metastasis or untreated active CNS (central nervous system) metastasis&#xD;
             or leptomeningeal metastasis.&#xD;
&#xD;
          -  Is currently participating and receiving an investigational drug or has participated&#xD;
             in a study of an investigational drug within 4 weeks&#xD;
&#xD;
          -  Has received other anti-tumor treatment within 4 weeks&#xD;
&#xD;
          -  Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first&#xD;
             administration of trial treatment&#xD;
&#xD;
          -  Curative radiation within 3 months of the first dose of trial treatment.&#xD;
&#xD;
          -  Subjects receiving immunosuppressive agents (such as steroids) for any reason should&#xD;
             be tapered off these drugs before initiation of trial treatment&#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_official>
    <last_name>Xiaolong Fu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Chest Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhonglin Chen</last_name>
    <phone>86-21-22200000</phone>
    <phone_ext>3115</phone_ext>
    <email>chestgcp@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shanghai Chest Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaolong Fu, MD</last_name>
      <phone>86-21-22200000</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>April 3, 2023</last_update_submitted>
  <last_update_submitted_qc>April 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 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>Carcinoma</mesh_term>
    <mesh_term>Thymoma</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/NCT04469725
org study id: KN046-205
nct id: NCT04469725
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a Phase 2, open-label, multi-center, single arm study in subjects with advanced
      thymic carcinoma after failure of platinum-based combination chemotherapy. Subjects should
      have documented progressive disease while on platinum-based combination chemotherapy. If
      subjects discontinued platinum-based therapy due to reasons other than progressive disease,
      subjects should have completed at least 2 cycles of platinum-based combination chemotherapy
      before the commencement of documented progressive disease. Subjects will be treated with
      KN046 5 milligram per kilogram every 2 weeks.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: subjects enrolled receive KN046
primary purpose: Treatment
masking: None (Open Label)
measure: ORR
time frame: up to 2 years
description: ORR (best overall response) per RECIST v1.1 calculated as the proportion of subjects with a best overall response defined as confirmed complete response or confirmed partial response (CR+PR) by Independent Review Committee;
measure: DOR
time frame: up to 3 years
description: DOR (duration of response), calculated as the time from the date of the first documented CR or PR to the first documented progression or death due to underlying cancer;
measure: DCR
time frame: up to 3 years
description: DCR (disease control rate), calculated as the proportion of subjects with best overall response of CR, PR, or SD (stable disease);
measure: CBR
time frame: up to 3 years
description: CBR (clinical benefit rate), calculated as the proportion of subjects with best overall response of CR, PR, or SD on at least 24 weeks;
measure: PFS
time frame: up to 3 years
description: PFS (progression free survival), defined as time from first dose of trial treatment to progression or death due to any cause;
measure: TTR
time frame: up to 3 years
description: TTR (time to response), calculated as the time from first dose of trial treatment to first documented response (CR+PR);
arm group label: Thymic carcinoma
arm group type: Experimental
description: enrolled subjects will receive KN046 every 2 weeks.
intervention type: Drug
intervention name: KN046
description: KN046 5 milligram per kilogram, every 2 weeks
arm group label: Thymic carcinoma
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Xiaolong Fu, MD
role: Principal Investigator
affiliation: Shanghai Chest Hospital
last name: Zhonglin Chen
phone: 86-21-22200000
phone ext: 3115
email: chestgcp@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Thymoma
sharing ipd: No