xml: <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/NCT05978492</url>
    </required_header>
    <id_info>
      <org_study_id>TXN10128-01</org_study_id>
      <nct_id>NCT05978492</nct_id>
    </id_info>
    <brief_title>A Study of TXN10128 in Subjects With Solid Tumors</brief_title>
    <official_title>A Multicenter, Open-label, Phase 1 Dose Escalation and Expansion Study of TXN10128, an Inhibitor of ENPP1 in Subjects With Locally Advanced (Unresectable) or Metastatic Solid Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Txinno Bioscience Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Txinno Bioscience 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 I clinical trial to primarily evaluate the safety, tolerability, and&#xD;
        addtionally assess pharmacokinetics, pharmacodynamics, and antitumor activity of&#xD;
        investigational product, TXN10128. The target subjects will be consisted of patients with&#xD;
        locally advanced (unresectable) or metastatic soild tumors.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a multicenter, open-label, phase 1 study of TXN10128, an inhibitor of ENPP1&#xD;
        (ectonucleotide pyrophosphatase/phosphodiesterase 1). Patients with locally advanced&#xD;
        (unresectable), or metastatic solid tumors that have relapsed or are refractory following the&#xD;
        last line of treatment will be enrolled.&#xD;
  &#xD;
        The primary objective is evaluating the safety and tolerability of TXN10128 to determine the&#xD;
        MTD. The secondary objective is characterizing the PK profile and evaluating preliminary&#xD;
        antitumor activity of TXN10128.&#xD;
  &#xD;
        This study consists of the dose-escalation and dose-expansion part. In dose-escalation part,&#xD;
        maximally 36 subjects can be enrolled across planned 6 dose levels. Bayesian optimal interval&#xD;
        (BOIN) design will be employed to find the MTD. The target DLT rate for determining the MTD&#xD;
        is 30% for this study.&#xD;
  &#xD;
        TXN10128 will be administered orally once daily for 21 days as a treatment cycle.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 27, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">March 31, 2025</primary_completion_date>
    <phase>Phase 1</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>Bayesian optimal interval (BOIN) design will be employed to find the MTD. The target DLT rate for determining the MTD is 30% for this study.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>DLT</measure>
      <time_frame>The first cycle (each cycle is 21 days)</time_frame>
      <description>Bayesian optimal interval (BOIN, Liu and Yuan [2015]) design will be employed to find the MTD. The target DLT rate for determining the MTD is 30% for this study. The maximum sample size for the study is 36 and a maximum of 12 subjects can be assigned to a dose level</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adverse events (AE)</measure>
      <time_frame>Up to 30 days from end of treatment</time_frame>
      <description>Adverse events (AE) defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0 at each dose level</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cmax</measure>
      <time_frame>Up to 21 days from Day 1 dose</time_frame>
      <description>The time to reach the maximum observed concentration (time)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC inf</measure>
      <time_frame>Up to 21 days from Day 1 dose</time_frame>
      <description>The area under the concentration-time curve extrapolated to infinity (mass*time/volume)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC last</measure>
      <time_frame>Up to 21 days from Day 1 dose</time_frame>
      <description>The area under the concentration (AUC) -time curve calculated to the last quantifiable concentration point (mass* time/volume)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tmax</measure>
      <time_frame>Up to 21 days from Day 1 dose</time_frame>
      <description>The time to reach the maximum observed concentration (time)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>T1/2</measure>
      <time_frame>Up to 21 days from Day 1 dose</time_frame>
      <description>Elimination half-life, determined as 0.693/Lambda_z (time)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vss</measure>
      <time_frame>Up to 21 days from Day 1 dose</time_frame>
      <description>Volume of distribution during the steady state phase (volume)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Best overall response (BOR)</measure>
      <time_frame>Up to 30 days from end of treatment</time_frame>
      <description>Best overall response will be summarized</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression free survival (PFS)</measure>
      <time_frame>Up to 30 days from end of treatment</time_frame>
      <description>The survival function will be estimated using the Kaplan-Meier product limit method. Median duration, with a two-sided Brookmeyer-Crowley 90% confidence interval and Kaplan-Meier estimates of survival proportions will be provided at specified time points.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate (DCR)</measure>
      <time_frame>Up to 30 days from end of treatment</time_frame>
      <description>The disease control rate is calculated as the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DOR)</measure>
      <time_frame>Up to 30 days from end of treatment</time_frame>
      <description>Duration of response is defined as the time from the date of the first documented response (CR or PR), to the date of first documented progression, or death due to study indication. Estimates will use Kaplan-Meier method</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall response rate (ORR)</measure>
      <time_frame>Up to 30 days from end of treatment</time_frame>
      <description>Overall response rate will be summarized with accompanying 90% exact binomial confidence interval (CI).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Solid Tumor</condition>
    <arm_group>
      <arm_group_label>Dose-escalation part</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>TXN10128 will be administered orally once daily for 21 days as a treatment cycle. TXN10128 will be evaluated across 6 dose levels.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>TXN10128</intervention_name>
      <description>Participants receive TXN10128 capsules orally once daily</description>
      <arm_group_label>Dose-escalation part</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female subjects ≥19 years of age at the time of informed consent.&#xD;
  &#xD;
            -  Histologically and/or cytologically confirmed any progressive, locally advanced&#xD;
               (unresectable), or metastatic solid tumors that have relapsed or are refractory&#xD;
               following the last line of treatment and for which prior standard therapy has been&#xD;
               ineffective, or standard therapy does not exist or is not considered appropriate.&#xD;
  &#xD;
            -  ECOG performance status of 0 or 1.&#xD;
  &#xD;
            -  Life expectancy of at least 12 weeks.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Has leptomeningeal disease.&#xD;
  &#xD;
            -  Experienced a Grade ≥3 immune-related adverse events (irAE) with prior immunotherapy&#xD;
               with the exception of non-clinically significant laboratory abnormalities.&#xD;
  &#xD;
            -  Prior organ transplantation.&#xD;
  &#xD;
            -  Known positive human immunodeficiency virus (HIV) infection.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Min-Hee Ryu, M.D., Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Asan Medical Center</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Do-Youn Oh, M.D., Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Seoul National Univ. Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Jin Seok Ahn, M.D., Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Samsung Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jong Heun Lee, Ph.D.</last_name>
      <phone>82 31 778 8688</phone>
      <email>jong@txinno.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Eun-Young Kwak, Ph.D.</last_name>
      <phone>82 31 778 8688</phone>
      <email>bella@txinno.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Seoul National Univ. Hospital</name>
        <address>
          <city>Seoul</city>
          <zip>03080</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yeebin Lee</last_name>
        <phone>+821023420073</phone>
        <email>lee.yeebin@cnres.com</email>
      </contact>
      <investigator>
        <last_name>Do-Youn Oh, M.D., Ph.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Asan Medical Center</name>
        <address>
          <city>Seoul</city>
          <zip>05505</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yeebin Lee</last_name>
        <phone>82 10 2342 0073</phone>
        <email>lee.yeebin@cnres.com</email>
      </contact>
      <investigator>
        <last_name>Min-Hee Ryu, M.D., Ph.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <link>
      <url>http://www.txinno.com</url>
      <description>Homepage of Txinno Bioscience</description>
    </link>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>ENPP1</keyword>
    <keyword>ENPP1 inhibitor</keyword>
    <keyword>TXN10128</keyword>
    <keyword>TxinnoBio</keyword>
    <keyword>Txinno Bioscicence</keyword>
    <keyword>Innate immune</keyword>
    <keyword>STING pathway</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05978492
  org study id: TXN10128-01
  nct id: NCT05978492
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a phase I clinical trial to primarily evaluate the safety, tolerability, and
        addtionally assess pharmacokinetics, pharmacodynamics, and antitumor activity of
        investigational product, TXN10128. The target subjects will be consisted of patients with
        locally advanced (unresectable) or metastatic soild tumors.
  This study is a multicenter, open-label, phase 1 study of TXN10128, an inhibitor of ENPP1
        (ectonucleotide pyrophosphatase/phosphodiesterase 1). Patients with locally advanced
        (unresectable), or metastatic solid tumors that have relapsed or are refractory following the
        last line of treatment will be enrolled.
  
        The primary objective is evaluating the safety and tolerability of TXN10128 to determine the
        MTD. The secondary objective is characterizing the PK profile and evaluating preliminary
        antitumor activity of TXN10128.
  
        This study consists of the dose-escalation and dose-expansion part. In dose-escalation part,
        maximally 36 subjects can be enrolled across planned 6 dose levels. Bayesian optimal interval
        (BOIN) design will be employed to find the MTD. The target DLT rate for determining the MTD
        is 30% for this study.
  
        TXN10128 will be administered orally once daily for 21 days as a treatment cycle.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Bayesian optimal interval (BOIN) design will be employed to find the MTD. The target DLT rate for determining the MTD is 30% for this study.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: DLT
  time frame: The first cycle (each cycle is 21 days)
  description: Bayesian optimal interval (BOIN, Liu and Yuan [2015]) design will be employed to find the MTD. The target DLT rate for determining the MTD is 30% for this study. The maximum sample size for the study is 36 and a maximum of 12 subjects can be assigned to a dose level
  measure: Adverse events (AE)
  time frame: Up to 30 days from end of treatment
  description: Adverse events (AE) defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0 at each dose level
  measure: Cmax
  time frame: Up to 21 days from Day 1 dose
  description: The time to reach the maximum observed concentration (time)
  measure: AUC inf
  time frame: Up to 21 days from Day 1 dose
  description: The area under the concentration-time curve extrapolated to infinity (mass*time/volume)
  measure: AUC last
  time frame: Up to 21 days from Day 1 dose
  description: The area under the concentration (AUC) -time curve calculated to the last quantifiable concentration point (mass* time/volume)
  measure: Tmax
  time frame: Up to 21 days from Day 1 dose
  description: The time to reach the maximum observed concentration (time)
  measure: T1/2
  time frame: Up to 21 days from Day 1 dose
  description: Elimination half-life, determined as 0.693/Lambda_z (time)
  measure: Vss
  time frame: Up to 21 days from Day 1 dose
  description: Volume of distribution during the steady state phase (volume)
  measure: Best overall response (BOR)
  time frame: Up to 30 days from end of treatment
  description: Best overall response will be summarized
  measure: Progression free survival (PFS)
  time frame: Up to 30 days from end of treatment
  description: The survival function will be estimated using the Kaplan-Meier product limit method. Median duration, with a two-sided Brookmeyer-Crowley 90% confidence interval and Kaplan-Meier estimates of survival proportions will be provided at specified time points.
  measure: Disease control rate (DCR)
  time frame: Up to 30 days from end of treatment
  description: The disease control rate is calculated as the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease
  measure: Duration of Response (DOR)
  time frame: Up to 30 days from end of treatment
  description: Duration of response is defined as the time from the date of the first documented response (CR or PR), to the date of first documented progression, or death due to study indication. Estimates will use Kaplan-Meier method
  measure: Overall response rate (ORR)
  time frame: Up to 30 days from end of treatment
  description: Overall response rate will be summarized with accompanying 90% exact binomial confidence interval (CI).
  arm group label: Dose-escalation part
  arm group type: Experimental
  description: TXN10128 will be administered orally once daily for 21 days as a treatment cycle. TXN10128 will be evaluated across 6 dose levels.
  intervention type: Drug
  intervention name: TXN10128
  description: Participants receive TXN10128 capsules orally once daily
  arm group label: Dose-escalation part
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Min-Hee Ryu, M.D., Ph.D.
  role: Principal Investigator
  affiliation: Asan Medical Center
  last name: Do-Youn Oh, M.D., Ph.D.
  role: Principal Investigator
  affiliation: Seoul National Univ. Hospital
  last name: Jin Seok Ahn, M.D., Ph.D.
  role: Principal Investigator
  affiliation: Samsung Medical Center
  last name: Jong Heun Lee, Ph.D.
  phone: 82 31 778 8688
  email: jong@txinno.com
  last name: Eun-Young Kwak, Ph.D.
  phone: 82 31 778 8688
  email: bella@txinno.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Korea, Republic of
  url: http://www.txinno.com
  description: Homepage of Txinno Bioscience
  responsible party type: Sponsor
  mesh term: Neoplasms
  sharing ipd: Undecided