<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/NCT03752723</url>
  </required_header>
  <id_info>
    <org_study_id>GX-I7-CA-006</org_study_id>
    <nct_id>NCT03752723</nct_id>
  </id_info>
  <brief_title>Study of GX-I7 in Combination With Pembrolizumab in Refractory or Relapsed (R/R) TNBC Subjects(GX-I7-CA-006/KEYNOTE-899)</brief_title>
  <official_title>A Phase 1b/2, Open Label, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacodynamics and Antitumor Activity of GX-I7 in Combination With Pembrolizumab in Subjects With Refractory or Relapsed (R/R) TNBC</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Genexine, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Genexine, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety and tolerability of escalating doses GX-I7 in combination with&#xD;
      standard dose pembrolizumab, and to evaluate objective response rate (ORR) in subjects with&#xD;
      refractory or relapsed TNBC&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 27, 2019</start_date>
  <completion_date type="Actual">May 11, 2023</completion_date>
  <primary_completion_date type="Actual">May 11, 2023</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence and nature of DLTs</measure>
    <time_frame>during the first 5 weeks</time_frame>
    <description>To evaluate the safety and tolerability of GX-I7 in combination with standard dose pembrolizumab</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence, nature and severity of adverse events</measure>
    <time_frame>up to 24month</time_frame>
    <description>graded according to NCI CTCAE v5.0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Objective response rate (ORR)</measure>
    <time_frame>up to 24month</time_frame>
    <description>defined as percentage of subjects with a complete response (CR) or partial response (PR) per RECIST v.1.1</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">84</enrollment>
  <condition>Triple Negative Breast Cancer</condition>
  <arm_group>
    <arm_group_label>combination with CPA, GX-I7, and pembrolizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental: combination&#xD;
Assigned interventions: CPA, GX-I7 and pembrolizumab</description>
  </arm_group>
  <arm_group>
    <arm_group_label>combination with GX-I7, and pembrolizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental: combination&#xD;
Assigned interventions: GX-I7 and pembrolizumab (without CPA)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GX-I7</intervention_name>
    <description>i.m.</description>
    <arm_group_label>combination with CPA, GX-I7, and pembrolizumab</arm_group_label>
    <arm_group_label>combination with GX-I7, and pembrolizumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>i.v.</description>
    <arm_group_label>combination with CPA, GX-I7, and pembrolizumab</arm_group_label>
    <arm_group_label>combination with GX-I7, and pembrolizumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cyclophosphamide</intervention_name>
    <description>i.v.</description>
    <arm_group_label>combination with CPA, GX-I7, and pembrolizumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          1. Triple negative must be defined as guidelines of American Society of Clinical&#xD;
             Oncology(ASCO)/ College of American Pathologist(CAP): Estrogen Receptor (ER) &lt; 1%&#xD;
             positive tumor nuclei, Progesterone Receptor (PR) &lt; 1% positive tumor nuclei, and&#xD;
             negative for HER2 by IHC 1+, 0 or negativity status confirmed by in situ hybridization&#xD;
             (ISH).&#xD;
&#xD;
          2. Subject must have received anthracycline and taxane based chemotherapy for TNBC&#xD;
&#xD;
          3. Has measurable disease as defined by RECIST 1.1 as assessed by the the local site&#xD;
             Investigator/radiology.&#xD;
&#xD;
          4. Female subjects, age ≥ 19 years at the time of consent.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. Known severe hypersensitivity (≥ Grade 3) to pembrolizumab, pembrolizumab formulation&#xD;
             excipients or GX-I7 formulation excipients or cyclophosphamide formulation.&#xD;
&#xD;
          2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with&#xD;
             an agent directed to another co-inhibitory T-cell receptor (ie, CTLA-4, OX-40, CD137)&#xD;
             or has previously participated in a Merck pembrolizumab (MK-3475) clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ajou Medical Center</name>
      <address>
        <city>Suwon-si</city>
        <state>Gyeonggi-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center</name>
      <address>
        <city>Goyang-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gachon University Gil Medical Center</name>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ewha Womans University Mokdong Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gangnam Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Anam Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Guro Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul ST.Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>June 8, 2023</last_update_submitted>
  <last_update_submitted_qc>June 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast cancer</keyword>
  <keyword>TNBC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triple Negative Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Pembrolizumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03752723
org study id: GX-I7-CA-006
nct id: NCT03752723
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
To evaluate the safety and tolerability of escalating doses GX-I7 in combination with
      standard dose pembrolizumab, and to evaluate objective response rate (ORR) in subjects with
      refractory or relapsed TNBC
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence and nature of DLTs
time frame: during the first 5 weeks
description: To evaluate the safety and tolerability of GX-I7 in combination with standard dose pembrolizumab
measure: Incidence, nature and severity of adverse events
time frame: up to 24month
description: graded according to NCI CTCAE v5.0
measure: Objective response rate (ORR)
time frame: up to 24month
description: defined as percentage of subjects with a complete response (CR) or partial response (PR) per RECIST v.1.1
arm group label: combination with CPA, GX-I7, and pembrolizumab
arm group type: Experimental
description: Experimental: combination
Assigned interventions: CPA, GX-I7 and pembrolizumab
arm group label: combination with GX-I7, and pembrolizumab
arm group type: Experimental
description: Experimental: combination
Assigned interventions: GX-I7 and pembrolizumab (without CPA)
intervention type: Drug
intervention name: GX-I7
description: i.m.
arm group label: combination with CPA, GX-I7, and pembrolizumab
arm group label: combination with GX-I7, and pembrolizumab
intervention type: Drug
intervention name: Pembrolizumab
description: i.v.
arm group label: combination with CPA, GX-I7, and pembrolizumab
arm group label: combination with GX-I7, and pembrolizumab
intervention type: Drug
intervention name: cyclophosphamide
description: i.v.
arm group label: combination with CPA, GX-I7, and pembrolizumab
criteria: 
gender: Female
gender based: Yes
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Triple Negative Breast Neoplasms
mesh term: Cyclophosphamide
mesh term: Pembrolizumab
sharing ipd: Undecided