<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/NCT03042182</url>
  </required_header>
  <id_info>
    <org_study_id>03</org_study_id>
    <nct_id>NCT03042182</nct_id>
  </id_info>
  <brief_title>Trial of Therapeutic Vaccine in Patients With Cholangiocarcinoma</brief_title>
  <acronym>cholangio</acronym>
  <official_title>Open Label Trial of Therapeutic Vaccine in Patients With Cholangiocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Immunitor LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Immunitor LLC</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cholangiocarcinoma (CCA) is a malignant neoplasm originating from the epithelial cells lining&#xD;
      the intra- or extrahepatic biliary ducts. It is the second-most common liver cancer, after&#xD;
      hepatocellular carcinoma (HCC). About 6,000 people in the United States develop bile duct&#xD;
      cancer each year. One-year survival is less than 25% and no effective and safe systemic&#xD;
      treatments are currently available. Last year the completion of open-label phase 2 trial&#xD;
      (NCT02256514) of hepcortespenlisimut-L (V5) has been reported, which has shown that two-third&#xD;
      of Mongolian patients with advanced HCC had a favorable clinical response, including complete&#xD;
      remissions and with overall survival over 90% after 1 year. So far a few patients with CCA&#xD;
      were treated with V5, but it appeared that their response rate was somewhat inferior to&#xD;
      patients with HCC since two (both with hemochromatosis) out six patients died within 6&#xD;
      months. In one patient who had improved clinically, the improvement was correlated with&#xD;
      decrease in CA19-9 tumor marker, but no marker profile information is available in regard to&#xD;
      other CCA patients. As V5 tablets are made from pooled blood of patients with HCC, in theory,&#xD;
      they will be not very useful to patients with CCA. The goal of this project is to manufacture&#xD;
      an immunotherapeutic formulation made from pooled heat- and chemically-inactivated blood from&#xD;
      donors with CCA and initiate pilot open-label trial in 20 cholangiocarcinoma patients. This&#xD;
      clinical trial will be conducted in collaboration with the National Cancer Center.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Upon obtaining regulatory and ethical approvals the Phase II single-arm study will be&#xD;
      initiated at the NCC involving 20 patients with confirmed CCA diagnosis. The trial will be&#xD;
      short, it will last only 2 months, but this will be sufficient to gauge the safety and&#xD;
      efficacy. Only those patients who have higher than normal levels of CA19-9 tumor marker will&#xD;
      be enrolled, which will serve as a surrogate marker in a manner alpha fetoprotein (AFP) has&#xD;
      been used as a predictor of clinical response in HCC patients. Additional primary endpoints&#xD;
      will be overall survival and changes in tumor burden, with secondary endpoints being liver&#xD;
      function tests and changes in quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 20, 2017</start_date>
  <completion_date type="Anticipated">April 20, 2020</completion_date>
  <primary_completion_date type="Anticipated">February 20, 2020</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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>one arm open label study to last 2 months</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in CA19.9 tumor marker induced by daily dose of oral vaccine V3-X of cholangiocarcinoma</measure>
    <time_frame>2 months</time_frame>
    <description>open label trial of once daily tablet of V3-X vaccine</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>safety of vaccine</measure>
    <time_frame>2 months</time_frame>
    <description>toxicity or adverse side effects, such as diarrhea and vomiting, we would have graded them according to accepted standards, e.g., NCI CTEP CTCAE.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Cholangiocarcinoma</condition>
  <arm_group>
    <arm_group_label>Single pill of V3-X vaccine administered once daily</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One pill of oral therapeutic vaccine V3-X administered to patients with cholangiocarcinoma for two months and changes in CA19.9 tumor marker from baseline levels versus post-treatment levels will be assessed as correlates of changes in tumor burden</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Oral therapeutic vaccine V3-X to treat cholangiocarcinoma</intervention_name>
    <description>One single pill of V3-X vaccine administered once per day to patients with cholangiocarcinoma</description>
    <arm_group_label>Single pill of V3-X vaccine administered once daily</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  only those positive for CA19.9&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant and lactating females&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>aldar bourinbaiar, MD/PhD</last_name>
    <role>Study Director</role>
    <affiliation>Immunitor LLC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Galyna Kutsyna, MD, MD/PhD</last_name>
    <email>kutsynagalyna@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Aldar Bourinbayar, MD</last_name>
    <phone>+97695130306</phone>
    <email>immunitor@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Immunitor LLC</name>
      <address>
        <city>Ulaanbaatar</city>
        <state>CA</state>
        <zip>13838</zip>
        <country>Mongolia</country>
      </address>
    </facility>
    <status>Enrolling by invitation</status>
  </location>
  <location>
    <facility>
      <name>National Cancer Center</name>
      <address>
        <city>Ulaanbaatar</city>
        <country>Mongolia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>batchuluun purev, md</last_name>
    </contact>
    <contact_backup>
      <last_name>munkhzaya chogsom, md</last_name>
    </contact_backup>
    <investigator>
      <last_name>batchuluun PUREV, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Mongolia</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>August 29, 2019</last_update_submitted>
  <last_update_submitted_qc>August 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2019</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>Cholangiocarcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_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/NCT03042182
org study id: 03
nct id: NCT03042182
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Cholangiocarcinoma (CCA) is a malignant neoplasm originating from the epithelial cells lining
      the intra- or extrahepatic biliary ducts. It is the second-most common liver cancer, after
      hepatocellular carcinoma (HCC). About 6,000 people in the United States develop bile duct
      cancer each year. One-year survival is less than 25% and no effective and safe systemic
      treatments are currently available. Last year the completion of open-label phase 2 trial
      (NCT02256514) of hepcortespenlisimut-L (V5) has been reported, which has shown that two-third
      of Mongolian patients with advanced HCC had a favorable clinical response, including complete
      remissions and with overall survival over 90% after 1 year. So far a few patients with CCA
      were treated with V5, but it appeared that their response rate was somewhat inferior to
      patients with HCC since two (both with hemochromatosis) out six patients died within 6
      months. In one patient who had improved clinically, the improvement was correlated with
      decrease in CA19-9 tumor marker, but no marker profile information is available in regard to
      other CCA patients. As V5 tablets are made from pooled blood of patients with HCC, in theory,
      they will be not very useful to patients with CCA. The goal of this project is to manufacture
      an immunotherapeutic formulation made from pooled heat- and chemically-inactivated blood from
      donors with CCA and initiate pilot open-label trial in 20 cholangiocarcinoma patients. This
      clinical trial will be conducted in collaboration with the National Cancer Center.
Upon obtaining regulatory and ethical approvals the Phase II single-arm study will be
      initiated at the NCC involving 20 patients with confirmed CCA diagnosis. The trial will be
      short, it will last only 2 months, but this will be sufficient to gauge the safety and
      efficacy. Only those patients who have higher than normal levels of CA19-9 tumor marker will
      be enrolled, which will serve as a surrogate marker in a manner alpha fetoprotein (AFP) has
      been used as a predictor of clinical response in HCC patients. Additional primary endpoints
      will be overall survival and changes in tumor burden, with secondary endpoints being liver
      function tests and changes in quality of life.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: one arm open label study to last 2 months
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in CA19.9 tumor marker induced by daily dose of oral vaccine V3-X of cholangiocarcinoma
time frame: 2 months
description: open label trial of once daily tablet of V3-X vaccine
measure: safety of vaccine
time frame: 2 months
description: toxicity or adverse side effects, such as diarrhea and vomiting, we would have graded them according to accepted standards, e.g., NCI CTEP CTCAE.
arm group label: Single pill of V3-X vaccine administered once daily
arm group type: Experimental
description: One pill of oral therapeutic vaccine V3-X administered to patients with cholangiocarcinoma for two months and changes in CA19.9 tumor marker from baseline levels versus post-treatment levels will be assessed as correlates of changes in tumor burden
intervention type: Biological
intervention name: Oral therapeutic vaccine V3-X to treat cholangiocarcinoma
description: One single pill of V3-X vaccine administered once per day to patients with cholangiocarcinoma
arm group label: Single pill of V3-X vaccine administered once daily
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: aldar bourinbaiar, MD/PhD
role: Study Director
affiliation: Immunitor LLC
last name: Galyna Kutsyna, MD, MD/PhD
email: kutsynagalyna@yahoo.com
last name: Aldar Bourinbayar, MD
phone: +97695130306
email: immunitor@gmail.com
facility: 
status: Enrolling by invitation
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Mongolia
responsible party type: Sponsor
mesh term: Cholangiocarcinoma
mesh term: Vaccines
sharing ipd: No