<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/NCT04414163</url>
  </required_header>
  <id_info>
    <org_study_id>IMC-001-201</org_study_id>
    <nct_id>NCT04414163</nct_id>
  </id_info>
  <brief_title>A Study of IMC-001 in Subjects With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type</brief_title>
  <official_title>An Open-label, Single-arm, Global Phase 2 Study to Investigate the Efficacy and Safety of IMC-001 in Patients With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ImmuneOncia Therapeutics Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ImmuneOncia Therapeutics Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <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, to investigate the efficacy and safety of IMC-001 in patients&#xD;
      with Relapsed or Refractory extranodal NK/T cell lymphoma, nasal type&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      IMC-001 is a PD-L1 targeting, fully human monoclonal antibody. The purpose of this study is&#xD;
      to determine and evaluate the efficacy and safety of IMC-001. 20mg/kg every 2 weeks, IV&#xD;
      infusion of IMC-001 will be tested in subjects with Relapsed or Refractory extranodal NK/T&#xD;
      cell lymphoma, nasal type.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 28, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2026</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of Objective Response Rate(ORR)</measure>
    <time_frame>1 year (Not confirmed yet)</time_frame>
    <description>Lugano criteria with LYRIC modification</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Extranodal NK/T-cell Lymphoma, Nasal Type</condition>
  <condition>Extranodal NK/T-cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>IMC-001</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single Dose level (IMC-001 20mg/kg, every 2 weeks)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IMC-001</intervention_name>
    <description>Single dose level for enrollment subject (IMC-001 20mg/kg every 2 weeks)</description>
    <arm_group_label>IMC-001</arm_group_label>
    <other_name>Not confirm yet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ENKTL diagnosis;&#xD;
&#xD;
               -  Histologically confirmed diagnosed with extranodal NK/T-cell lymphoma, nasal type&#xD;
&#xD;
               -  At least 1 previous line of systemic therapy&#xD;
&#xD;
               -  Documented disease progression of last therapy&#xD;
&#xD;
          2. Adult age(as defined by respective country)&#xD;
&#xD;
          3. The nature of the study and voluntarily sign an ICF&#xD;
&#xD;
          4. ECOG 0 or1&#xD;
&#xD;
          5. Adequate hematologic function, hepatic function, and renal function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previously treated with an anti-PD-L1 or anti-PD-1 antibody&#xD;
&#xD;
          2. Known presence of symptomatic CNS metastases&#xD;
&#xD;
          3. Prior allogeneic HSCT or solid organ transplantation&#xD;
&#xD;
          4. Any active autoimmune disease or a documented history of autoimmune disease&#xD;
&#xD;
          5. Apparent active or latent TB and known viral infection with hepatitis B virus or&#xD;
             hepatitis C virus&#xD;
&#xD;
          6. Pregnant or lactating&#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>JiEun Oh</last_name>
    <role>Study Director</role>
    <affiliation>ImmuneOncia Therapeutics Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>JiEun Oh</last_name>
    <phone>+82 31 707 8133</phone>
    <email>IOCSO@immuneoncia.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>MinYoung Son</last_name>
    <phone>+82 31 707 8133</phone>
    <email>IOCSO@immuneoncia.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Chonnam National University Hwasun Hospital</name>
      <address>
        <city>Hwasun</city>
        <state>Chonnam</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Deok-Hwan Yang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>ChungBuk National University Hospital</name>
      <address>
        <city>Cheonju</city>
        <state>Chungbuk</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jihyun Kwon</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gyeongsang National University Hospital</name>
      <address>
        <city>Jinju</city>
        <state>Gyeongsangnam-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Gyeong-Won Lee</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gachon University Gil Medical Center</name>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Kwai Han Yoo</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Dok Hyun Yoon</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Won Seog Kim</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Junshik Hong</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ulsan University Hospital</name>
      <address>
        <city>Ulsan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jae-Cheol Jo</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>March 24, 2023</last_update_submitted>
  <last_update_submitted_qc>March 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>IMC-001</keyword>
  <keyword>IMC-001-201</keyword>
  <keyword>DISTINKT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, T-Cell</mesh_term>
    <mesh_term>Lymphoma, T-Cell, Peripheral</mesh_term>
    <mesh_term>Lymphoma, Extranodal NK-T-Cell</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/NCT04414163
org study id: IMC-001-201
nct id: NCT04414163
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a phase 2, Open-label, to investigate the efficacy and safety of IMC-001 in patients
      with Relapsed or Refractory extranodal NK/T cell lymphoma, nasal type
IMC-001 is a PD-L1 targeting, fully human monoclonal antibody. The purpose of this study is
      to determine and evaluate the efficacy and safety of IMC-001. 20mg/kg every 2 weeks, IV
      infusion of IMC-001 will be tested in subjects with Relapsed or Refractory extranodal NK/T
      cell lymphoma, nasal type.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Occurrence of Objective Response Rate(ORR)
time frame: 1 year (Not confirmed yet)
description: Lugano criteria with LYRIC modification
arm group label: IMC-001
arm group type: Experimental
description: Single Dose level (IMC-001 20mg/kg, every 2 weeks)
intervention type: Drug
intervention name: IMC-001
description: Single dose level for enrollment subject (IMC-001 20mg/kg every 2 weeks)
arm group label: IMC-001
other name: Not confirm yet
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: JiEun Oh
role: Study Director
affiliation: ImmuneOncia Therapeutics Inc.
last name: JiEun Oh
phone: +82 31 707 8133
email: IOCSO@immuneoncia.com
last name: MinYoung Son
phone: +82 31 707 8133
email: IOCSO@immuneoncia.com
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, T-Cell
mesh term: Lymphoma, T-Cell, Peripheral
mesh term: Lymphoma, Extranodal NK-T-Cell
sharing ipd: No