<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/NCT04505839</url>
  </required_header>
  <id_info>
    <org_study_id>STP-ST-01</org_study_id>
    <nct_id>NCT04505839</nct_id>
  </id_info>
  <brief_title>First-In-Human Dose-Escalation Study of STP1002 in Patients With Advanced-Stage Solid Tumors</brief_title>
  <official_title>First-In-Human Dose-Escalation Study of STP1002 in Patients With Advanced-Stage Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ST Pharm Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>KCRN Research, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>ST Pharm Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, multicenter, dose-escalation study to evaluate the safety,&#xD;
      tolerability, and pharmacokinetics (PK) and to determine the maximum tolerated dose (MTD) of&#xD;
      STP1002 in patients with advanced-stage solid tumors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 30, 2020</start_date>
  <completion_date type="Anticipated">November 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2023</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dose limiting toxicities (DLTs)</measure>
    <time_frame>28 days</time_frame>
    <description>DLTs are defined as any of the following adverse events (AEs) that are possibly or probably related to the trial regimen occurring during Cycle 1</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatment-emergent adverse events (TEAEs)</measure>
    <time_frame>24 months</time_frame>
    <description>Number and severity of TEAEs, treatment-related AEs, and SAEs for all dose groups according to the NCI CTCAE v5.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The pharmacokinetics of STP1002</measure>
    <time_frame>24 months</time_frame>
    <description>Plasma concentration of STP1002 following oral administration</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Advanced Solid Tumor</condition>
  <arm_group>
    <arm_group_label>STP1002</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>STP1002</intervention_name>
    <description>Oral capsule, QD</description>
    <arm_group_label>STP1002</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Advanced-stage solid tumor (metastatic or locally advanced and unresectable) with&#xD;
             histologically confirmed diagnosis of CRC, NSCLC, GC, RCC, or HCC&#xD;
&#xD;
          -  Measurable lesion(s) according to RECIST 1.1 criteria&#xD;
&#xD;
          -  Performance status of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale.&#xD;
&#xD;
          -  Ability to swallow capsules&#xD;
&#xD;
          -  Received last chemotherapy, biologic, or investigational therapy at least 4 weeks&#xD;
             prior to first dosing of study treatment&#xD;
&#xD;
          -  Has received or is intolerant to all standard of care treatment options with known&#xD;
             clinical benefit&#xD;
&#xD;
          -  Life expectancy of more than 3 months&#xD;
&#xD;
          -  Adequate hematological, hepatic and renal function&#xD;
&#xD;
          -  For women of childbearing potential, a negative serum pregnancy test performed within&#xD;
             7 days prior to start of treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Received treatment within the last 28 days with a drug that has not received&#xD;
             regulatory approval for any indication at the time of study entry&#xD;
&#xD;
          -  Major surgery within the last 28 days prior to the first dose of investigational drug&#xD;
&#xD;
          -  Prior radiation therapy within 14 days prior to study Cycle 1 Day 1 and/or persistence&#xD;
             of radiation-related adverse effects.&#xD;
&#xD;
          -  Concurrent treatment with any anticancer agent&#xD;
&#xD;
          -  Currently taking either strong CYP inhibitors or inducers&#xD;
&#xD;
          -  Known brain metastases, uncontrolled seizure disorder, or active neurologic disease&#xD;
&#xD;
          -  Significant cardiovascular impairment&#xD;
&#xD;
          -  Pregnant or nursing&#xD;
&#xD;
          -  Known HIV infection, active hepatitis C and/or hepatitis B infection&#xD;
&#xD;
          -  Known bleeding disorder or coagulopathy&#xD;
&#xD;
          -  Active drug or alcohol abuse or history of alcohol or drug abuse during the last two&#xD;
             years.&#xD;
&#xD;
          -  Diagnosis of osteoporosis at the time of the screening&#xD;
&#xD;
          -  Any history of retinal pathology including diabetic retinopathy, macular degeneration,&#xD;
             or other retinal degenerative disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Denver</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>August 2, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>July 28, 2023</last_update_submitted>
  <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 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>Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT04505839
org study id: STP-ST-01
nct id: NCT04505839
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is an open-label, multicenter, dose-escalation study to evaluate the safety,
      tolerability, and pharmacokinetics (PK) and to determine the maximum tolerated dose (MTD) of
      STP1002 in patients with advanced-stage solid tumors.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Dose limiting toxicities (DLTs)
time frame: 28 days
description: DLTs are defined as any of the following adverse events (AEs) that are possibly or probably related to the trial regimen occurring during Cycle 1
measure: Treatment-emergent adverse events (TEAEs)
time frame: 24 months
description: Number and severity of TEAEs, treatment-related AEs, and SAEs for all dose groups according to the NCI CTCAE v5.0
measure: The pharmacokinetics of STP1002
time frame: 24 months
description: Plasma concentration of STP1002 following oral administration
arm group label: STP1002
arm group type: Experimental
intervention type: Drug
intervention name: STP1002
description: Oral capsule, QD
arm group label: STP1002
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms