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/NCT06016270</url>
    </required_header>
    <id_info>
      <org_study_id>STCUBE-002</org_study_id>
      <nct_id>NCT06016270</nct_id>
    </id_info>
    <brief_title>A Study of hSTC810 in Combination With Paclitaxel in Relapsed or Refractory Extensive Stage Small Cell Lung Cancer</brief_title>
    <official_title>A Phase Ib/II Study of hSTC810 in Combination With Paclitaxel in Relapsed or Refractory Extensive Stage Small Cell Lung Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>STCube, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>STCube, Inc.</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this clinical study is to assess the safety and efficacy of hSTC810 and&#xD;
        paclitaxel combination therapy in patients with relapsed or refractory extensive stage small&#xD;
        cell lung cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will be conducted in 2 parts. Phase Ib will evaluate the safety of the combination&#xD;
        of hSTC810 with a standard dose of paclitaxel using a 3+3 dose escalation design. Phase II&#xD;
        will evaluate the efficacy of hSTC810 + paclitaxel combination therapy using a Simon 2-stage&#xD;
        method.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">October 2027</completion_date>
    <primary_completion_date type="Anticipated">November 2024</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>Overall Response Rate (ORR)</measure>
      <time_frame>3 months</time_frame>
      <description>Percentage of patients with confirmed Confirmed Response (CR) or Partial Response (PR) as defined by RECIST 1.1 at 3 months</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Progression Free Survival (PFS) rate</measure>
      <time_frame>6 months</time_frame>
      <description>Proportion of patients without documented progression of disease and alive at 6 months</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Safety and tolerability</measure>
      <time_frame>Up to 4 years</time_frame>
      <description>Incidence, causality, and nature of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Response Rate (ORR)</measure>
      <time_frame>Up to 4 years</time_frame>
      <description>Investigator assessed ORR defined by RECIST 1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DoR)</measure>
      <time_frame>Up to 4 years</time_frame>
      <description>Time from the date of first documented CR or PR until the date of documented progression or death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression Free Survival (PFS)</measure>
      <time_frame>Up to 4 years</time_frame>
      <description>Time from first dose until the date of objective disease progression or death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical Benefit Rate (CBR)</measure>
      <time_frame>Up to 4 years</time_frame>
      <description>Percentage of evaluable patients with CR, PR, or Stable Disease (SD) lasting ≥ 24 weeks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Survival (OS)</measure>
      <time_frame>Up to 4 years</time_frame>
      <description>Time from first dose of study drug until the date of death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Survival (OS) rate</measure>
      <time_frame>12 months</time_frame>
      <description>Proportion of patients alive at 12 months after the first dose of study drug</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum plasma concentration (Cmax)</measure>
      <time_frame>Up to 21 days</time_frame>
      <description>Maximum plasma concentration of hSTC810 to evaluate PK parameters</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the concentration-time curve from 0 to 21 days (AUC0-21)</measure>
      <time_frame>Up to 21 days</time_frame>
      <description>AUC from 0 to 21 days to evaluate PK parameters</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the concentration-time curve extrapolated from 0 to infinity (AUCo-inf)</measure>
      <time_frame>Up to 21 days</time_frame>
      <description>AUC from time 0 to infinity to evaluate total drug exposure over time</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of anti-drug antibodies (ADA)</measure>
      <time_frame>Up to 4 years</time_frame>
      <description>Number and percentage of patients with positive ADAs</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">130</enrollment>
    <condition>Extensive Stage Small Cell Lung Cancer</condition>
    <arm_group>
      <arm_group_label>hSTC810 400 mg + Paclitaxel</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>hSTC810 400 mg will be administered with a standard dose of paclitaxel</description>
    </arm_group>
    <arm_group>
      <arm_group_label>hSTC810 800 mg + Paclitaxel</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>hSTC810 800 mg will be administered with a standard dose of paclitaxel</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>hSTC810 400 mg + Paclitaxel</intervention_name>
      <description>hSTC810 400 mg and paclitaxel 175 mg/m2 will be administered as an intravenous (IV) infusion&#xD;
  Paclitaxel: 175 mg/m2 will be administered as an IV infusion</description>
      <arm_group_label>hSTC810 400 mg + Paclitaxel</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>hSTC810 800 mg + Paclitaxel</intervention_name>
      <description>hSTC810 800 mg and paclitaxel 175 mg/m2 will be administered as an IV infusion</description>
      <arm_group_label>hSTC810 800 mg + Paclitaxel</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Ability to understand and sign an informed consent form&#xD;
  &#xD;
            -  Male or female ≥ 18 years of age&#xD;
  &#xD;
            -  Histologically or cytologically confirmed SCLC&#xD;
  &#xD;
            -  R/R ES-SCLC on or after platinum-based chemotherapy for SCLC with documented disease&#xD;
               progression&#xD;
  &#xD;
            -  At least 1 measurable lesion as defined by RECIST 1.1&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 or 1&#xD;
  &#xD;
            -  Life expectancy of at least 3 months&#xD;
  &#xD;
            -  Adequate organ function as described in the protocol&#xD;
  &#xD;
            -  For female or male patients with reproductive potential: Agree to use contraception&#xD;
               throughout the study and at least 5 months after the last dose.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known active leptomeningeal disease (carcinomatous meningitis)&#xD;
  &#xD;
            -  Known active and uncontrolled central nervous system (CNS) metastases&#xD;
  &#xD;
            -  Treatment with immunotherapy, chemotherapy, targeted small molecule therapy, or any&#xD;
               other investigational agent &lt; 14 days prior to initiation of study treatment&#xD;
  &#xD;
            -  Treatment with radiation therapy &lt; 14 days prior to initiation of study treatment&#xD;
  &#xD;
            -  Major surgery &lt; 21 days prior to initiation of study treatment&#xD;
  &#xD;
            -  Received live vaccine &lt; 30 days prior to initiation of study treatment, including&#xD;
               intranasal influenza vaccine&#xD;
  &#xD;
            -  History of another primary malignancy with protocol-defined exceptions&#xD;
  &#xD;
            -  Active or history of autoimmune disease requiring systemic treatment&#xD;
  &#xD;
            -  Receiving high doses of steroids or other immunosuppressive medications&#xD;
  &#xD;
            -  Active hepatitis B or C infection&#xD;
  &#xD;
            -  Active or history of non-infectious pneumonitis requiring treatment with steroids&#xD;
  &#xD;
            -  Active uncontrolled viral, fungal, or bacterial infection including tuberculosis&#xD;
  &#xD;
            -  Pregnant or breastfeeding female patients&#xD;
  &#xD;
            -  History of severe hypersensitivity reaction to a monoclonal antibody treatment&#xD;
  &#xD;
            -  History of severe hypersensitivity reaction or ≥ Grade 3 adverse event (AE) to&#xD;
               paclitaxel treatment&#xD;
  &#xD;
            -  History of cerebral vascular event, unstable angina, myocardial infarction, or cardiac&#xD;
               symptoms within 6 months prior to screening&#xD;
  &#xD;
            -  QT Corrected for Fridericia's method (QTcF) &gt; 470 ms at screening&#xD;
  &#xD;
            -  Lack of resolution of any toxicity to max Grade 1 (except alopecia)&#xD;
  &#xD;
            -  Active or history of any condition, therapy, or lab abnormality that may interfere&#xD;
               with the patient participation for the full duration of the study&#xD;
  &#xD;
            -  Known psychiatric or substance use disorder&#xD;
  &#xD;
            -  Positive Coronavirus disease 2019 (COVID-19) test at screening&#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_contact>
      <last_name>Jiwon Hur, MD</last_name>
      <phone>82-2-551-3370</phone>
      <email>hurjw@stcube.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 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 29, 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>Lung Neoplasms</mesh_term>
      <mesh_term>Small Cell Lung Carcinoma</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Paclitaxel</mesh_term>
      <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06016270
  org study id: STCUBE-002
  nct id: NCT06016270
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this clinical study is to assess the safety and efficacy of hSTC810 and
        paclitaxel combination therapy in patients with relapsed or refractory extensive stage small
        cell lung cancer.
  The study will be conducted in 2 parts. Phase Ib will evaluate the safety of the combination
        of hSTC810 with a standard dose of paclitaxel using a 3+3 dose escalation design. Phase II
        will evaluate the efficacy of hSTC810 + paclitaxel combination therapy using a Simon 2-stage
        method.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Overall Response Rate (ORR)
  time frame: 3 months
  description: Percentage of patients with confirmed Confirmed Response (CR) or Partial Response (PR) as defined by RECIST 1.1 at 3 months
  measure: Progression Free Survival (PFS) rate
  time frame: 6 months
  description: Proportion of patients without documented progression of disease and alive at 6 months
  measure: Safety and tolerability
  time frame: Up to 4 years
  description: Incidence, causality, and nature of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
  measure: Overall Response Rate (ORR)
  time frame: Up to 4 years
  description: Investigator assessed ORR defined by RECIST 1.1
  measure: Duration of Response (DoR)
  time frame: Up to 4 years
  description: Time from the date of first documented CR or PR until the date of documented progression or death
  measure: Progression Free Survival (PFS)
  time frame: Up to 4 years
  description: Time from first dose until the date of objective disease progression or death
  measure: Clinical Benefit Rate (CBR)
  time frame: Up to 4 years
  description: Percentage of evaluable patients with CR, PR, or Stable Disease (SD) lasting ≥ 24 weeks
  measure: Overall Survival (OS)
  time frame: Up to 4 years
  description: Time from first dose of study drug until the date of death
  measure: Overall Survival (OS) rate
  time frame: 12 months
  description: Proportion of patients alive at 12 months after the first dose of study drug
  measure: Maximum plasma concentration (Cmax)
  time frame: Up to 21 days
  description: Maximum plasma concentration of hSTC810 to evaluate PK parameters
  measure: Area under the concentration-time curve from 0 to 21 days (AUC0-21)
  time frame: Up to 21 days
  description: AUC from 0 to 21 days to evaluate PK parameters
  measure: Area under the concentration-time curve extrapolated from 0 to infinity (AUCo-inf)
  time frame: Up to 21 days
  description: AUC from time 0 to infinity to evaluate total drug exposure over time
  measure: Incidence of anti-drug antibodies (ADA)
  time frame: Up to 4 years
  description: Number and percentage of patients with positive ADAs
  arm group label: hSTC810 400 mg + Paclitaxel
  arm group type: Experimental
  description: hSTC810 400 mg will be administered with a standard dose of paclitaxel
  arm group label: hSTC810 800 mg + Paclitaxel
  arm group type: Experimental
  description: hSTC810 800 mg will be administered with a standard dose of paclitaxel
  intervention type: Drug
  intervention name: hSTC810 400 mg + Paclitaxel
  description: hSTC810 400 mg and paclitaxel 175 mg/m2 will be administered as an intravenous (IV) infusion
  Paclitaxel: 175 mg/m2 will be administered as an IV infusion
  arm group label: hSTC810 400 mg + Paclitaxel
  intervention type: Drug
  intervention name: hSTC810 800 mg + Paclitaxel
  description: hSTC810 800 mg and paclitaxel 175 mg/m2 will be administered as an IV infusion
  arm group label: hSTC810 800 mg + Paclitaxel
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jiwon Hur, MD
  phone: 82-2-551-3370
  email: hurjw@stcube.com
  responsible party type: Sponsor
  mesh term: Lung Neoplasms
  mesh term: Small Cell Lung Carcinoma
  mesh term: Paclitaxel
  mesh term: Albumin-Bound Paclitaxel
  sharing ipd: No