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/NCT05971862</url>
    </required_header>
    <id_info>
      <org_study_id>OSCO-P1302</org_study_id>
      <nct_id>NCT05971862</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SKI-G-801 in Patients With Advanced Solid Tumors</brief_title>
    <official_title>An Open-label, Multi-center, Dose-escalation and Dose-finding, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SKI- G-801 as Monotherapy in Patients With Advanced Solid Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Oscotec Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Oscotec 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>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a phase I study intended to determine the MTD and RP2D of SKI-G-801 monotherapy by&#xD;
        assessing the safety and tolerability including dose-limiting toxicity (DLT) at various dose&#xD;
        levels and to explore the efficacy and PK in patients with advanced solid tumors.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is an open-label, monotherapy study in patients with advanced solid tumors, to evaluate&#xD;
        the safety, tolerability, and pharmacokinetics (PK) of multiple ascending doses of&#xD;
        SKI-O-801(Denfivontinib). A total of 36 subjects are planned to participate in 6 cohorts&#xD;
        (traditional 3+3 design). In each cohort, 3 subjects will receive SKI-O-801. Dosing will be&#xD;
        initiated with a 100 mg once daily (QD) dose cohort and escalated to 500 mg QD. After 1 cycle&#xD;
        (28 days) of treatment if 3 subjects in each cohort have no DLT(Dose Limiting Toxicity),&#xD;
        escalate the next dose level by Safety Review Committee decision.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 25, 2022</start_date>
    <completion_date type="Anticipated">October 4, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 23, 2024</primary_completion_date>
    <phase>Phase 1</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>Determination of the MTD and/or RP2D based on DLTs</measure>
      <time_frame>Study Day 1 up to Day 28 (each cycle is 28 days)</time_frame>
      <description>For DLTs, the number of subjects, incidence, and number of events will be presented by dose group</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The number of treatment discontinuation or dose reduction</measure>
      <time_frame>Approximately 2 year</time_frame>
      <description>The number of treatment discontinuation or dose reduction due to ADRs(Adverse Drug Reactions) will be presented by dose group.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>AEs(Adverse event)</measure>
      <time_frame>Approximately 2 year</time_frame>
      <description>The number of AEs, the number of subjects affected, and the incidence will be presented.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Laboratory tests</measure>
      <time_frame>Approximaely 8 weeks</time_frame>
      <description>The number of participants with abnormal Laboratory test results such as hematology and chemistry lab results.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cmax</measure>
      <time_frame>Approximately 29 days (Up to Cycle 2 Day 1)</time_frame>
      <description>Maximum Plasma Concentration of SKI-G-801</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC</measure>
      <time_frame>Approximately 29 days (Up to Cycle 2 Day 1)</time_frame>
      <description>Area under the plasma concentration versus time curve of SKI-G-801</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective Response Rate (ORR)</measure>
      <time_frame>Approximately 2 year</time_frame>
      <description>The frequency and percentage of ORR will be presented by dose group using best overall response (BOR) based on RECIST version 1.1</description>
    </secondary_outcome>
    <number_of_arms>6</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Advanced Solid Tumor</condition>
    <arm_group>
      <arm_group_label>SKI-G-801(Denfivontinib) 100mg QD</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Administered orally</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SKI-G-801(Denfivontinib) 150mg QD</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Administered orally</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SKI-G-801(Denfivontinib) 225mg QD</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Administered orally</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SKI-G-801(Denfivontinib) 300mg QD</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Administered orally</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SKI-G-801(Denfivontinib) 400mg QD</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Administered orally</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SKI-G-801(Denfivontinib) 500mg QD</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Administered orally</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>SKI-G-801</intervention_name>
      <description>Oral SKI-G-801(Denfivontinib) will be daily administered based on dose level.</description>
      <arm_group_label>SKI-G-801(Denfivontinib) 100mg QD</arm_group_label>
      <arm_group_label>SKI-G-801(Denfivontinib) 150mg QD</arm_group_label>
      <arm_group_label>SKI-G-801(Denfivontinib) 225mg QD</arm_group_label>
      <arm_group_label>SKI-G-801(Denfivontinib) 300mg QD</arm_group_label>
      <arm_group_label>SKI-G-801(Denfivontinib) 400mg QD</arm_group_label>
      <arm_group_label>SKI-G-801(Denfivontinib) 500mg QD</arm_group_label>
      <other_name>Denfivontinib</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male and female adults aged 19 years and older&#xD;
  &#xD;
            -  Subjects with histologically and/or cytologically confirmed, unresectable advanced or&#xD;
               metastatic solid tumors that are confirmed as PD after the standard of care currently&#xD;
               known to have clinical benefits, or for which no currently available standard&#xD;
               therapies exist due to intolerance, ineligibility, refusal, etc.&#xD;
  &#xD;
            -  At least 1 evaluable lesion based on RECIST version 1.1 (the irradiated area or&#xD;
               biopsied lesion will be considered evaluable if PD is demonstrated).&#xD;
  &#xD;
            -  The Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1&#xD;
  &#xD;
            -  Life expectancy of at least 12 weeks&#xD;
  &#xD;
            -  The last screening test results obtained within 7 days prior to the first dose of the&#xD;
               IP (baseline) meet the following (with no administration of granulocyte&#xD;
               colony-stimulating factor [G-CSF] or erythropoietin [EPO], or transfusion within 14&#xD;
               days prior to the laboratory tests)&#xD;
  &#xD;
                 1. Hematological function ANC ≥1,500/μL Hemoglobin ≥9 g/dL Platelet count&#xD;
                    ≥100,000/μL&#xD;
  &#xD;
                 2. Renal function: Creatinine clearance (CrCl) ≥45 mL/min (MDRD equation)&#xD;
  &#xD;
                 3. Hepatic function AST ≤2.0 × ULN ALT ≤2.0 × ULN (AST/ALT ≤5 × ULN, if hepatic&#xD;
                    metastasis is confirmed) Total bilirubin ≤1.5 × ULN (&lt;3.0 × ULN, if Gilbert's&#xD;
                    syndrome is confirmed)&#xD;
  &#xD;
                 4. Blood coagulation function: prothrombin time (PT) (international normalized ratio&#xD;
                    [INR]) and activated partial thromboplastin time (aPTT) ≤1.5 × ULN (with an&#xD;
                    exception of PT or aPTT in the therapeutic range as per the purpose of&#xD;
                    anticoagulants if the subject is taking anticoagulants such as warfarin, heparin,&#xD;
                    or low molecular weight heparin)&#xD;
  &#xD;
            -  Voluntary written consent to participate in this study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  7th line or greater palliative systemic anti-cancer therapy for advanced or metastatic&#xD;
               solid tumors (postoperative adjuvant therapy is considered as a single line of therapy&#xD;
               if the disease recurs within 6 months after the last treatment, while endocrine&#xD;
               therapy is excluded from the line of therapy)&#xD;
  &#xD;
            -  History of AXL inhibitors&#xD;
  &#xD;
            -  Difficulty (e.g., problem swallowing) in oral administration of SKI-G-801 or disease&#xD;
               (celiac disease, Crohn's disease, or intestinal resection which is clinically&#xD;
               significant or impacts absorption) which impact absorption&#xD;
  &#xD;
            -  Hypersensitivity to the active ingredient or excipients of SKI-G-801&#xD;
  &#xD;
            -  Major surgery within 4 weeks prior to IP administration&#xD;
  &#xD;
            -  Minor surgery within 2 weeks prior to IP administration&#xD;
  &#xD;
            -  Women who have a positive pregnancy test or are pregnant or breastfeeding at&#xD;
               screening, or female subjects of childbearing potential or male subjects who do not&#xD;
               agree to remain abstinent or use effective methods of contraception** for at least 27&#xD;
               weeks (female subjects) or 14 weeks (male subjects) after the last dose of the IP&#xD;
  &#xD;
               **Effective forms of contraception are defined as the following:&#xD;
  &#xD;
                 1. Hormonal contraceptives (implants, injectables, oral contraceptives, etc.)&#xD;
  &#xD;
                 2. Intrauterine device or intrauterine system (copper loop, hormone containing&#xD;
                    intrauterine system)&#xD;
  &#xD;
                 3. Surgical sterilization (vasectomy, tubal ligation, etc.) of a subject or spouse&#xD;
                    (or partner)&#xD;
  &#xD;
                 4. Double-barrier method with spermicide (including condom, diaphragm, vaginal&#xD;
                    sponge, or cervical cap; a male and a female condom must not be used together)&#xD;
  &#xD;
            -  Toxicity associated with prior anti-cancer therapy that does not resolve to Grade ≤1&#xD;
               or baseline (with the exceptions of alopecia [any grade], Grade ≤2 neuropathy, and&#xD;
               endocrinopathy that is not controlled by hormone replacement therapy)&#xD;
  &#xD;
            -  History of using another investigational product/device within 4 weeks (or 5&#xD;
               half-lives, whichever is shorter) prior to IP administration&#xD;
  &#xD;
            -  Ineligibility or inability to participate in the study at the judgement of the&#xD;
               investigator&#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_contact>
      <last_name>MinKi Kang</last_name>
      <phone>+820316287624</phone>
      <email>mkkang@oscotec.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Yonsei University College of Medicine Severance Hospital</name>
        <address>
          <city>Seoul</city>
          <zip>03722</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </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>
    </location>
    <location>
      <facility>
        <name>Samsung Medical Center</name>
        <address>
          <city>Seoul</city>
          <zip>06351</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 29, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 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>
  
  
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/NCT05971862
  org study id: OSCO-P1302
  nct id: NCT05971862
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This is a phase I study intended to determine the MTD and RP2D of SKI-G-801 monotherapy by
        assessing the safety and tolerability including dose-limiting toxicity (DLT) at various dose
        levels and to explore the efficacy and PK in patients with advanced solid tumors.
  This is an open-label, monotherapy study in patients with advanced solid tumors, to evaluate
        the safety, tolerability, and pharmacokinetics (PK) of multiple ascending doses of
        SKI-O-801(Denfivontinib). A total of 36 subjects are planned to participate in 6 cohorts
        (traditional 3+3 design). In each cohort, 3 subjects will receive SKI-O-801. Dosing will be
        initiated with a 100 mg once daily (QD) dose cohort and escalated to 500 mg QD. After 1 cycle
        (28 days) of treatment if 3 subjects in each cohort have no DLT(Dose Limiting Toxicity),
        escalate the next dose level by Safety Review Committee decision.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Determination of the MTD and/or RP2D based on DLTs
  time frame: Study Day 1 up to Day 28 (each cycle is 28 days)
  description: For DLTs, the number of subjects, incidence, and number of events will be presented by dose group
  measure: The number of treatment discontinuation or dose reduction
  time frame: Approximately 2 year
  description: The number of treatment discontinuation or dose reduction due to ADRs(Adverse Drug Reactions) will be presented by dose group.
  measure: AEs(Adverse event)
  time frame: Approximately 2 year
  description: The number of AEs, the number of subjects affected, and the incidence will be presented.
  measure: Laboratory tests
  time frame: Approximaely 8 weeks
  description: The number of participants with abnormal Laboratory test results such as hematology and chemistry lab results.
  measure: Cmax
  time frame: Approximately 29 days (Up to Cycle 2 Day 1)
  description: Maximum Plasma Concentration of SKI-G-801
  measure: AUC
  time frame: Approximately 29 days (Up to Cycle 2 Day 1)
  description: Area under the plasma concentration versus time curve of SKI-G-801
  measure: Objective Response Rate (ORR)
  time frame: Approximately 2 year
  description: The frequency and percentage of ORR will be presented by dose group using best overall response (BOR) based on RECIST version 1.1
  arm group label: SKI-G-801(Denfivontinib) 100mg QD
  arm group type: Experimental
  description: Administered orally
  arm group label: SKI-G-801(Denfivontinib) 150mg QD
  arm group type: Experimental
  description: Administered orally
  arm group label: SKI-G-801(Denfivontinib) 225mg QD
  arm group type: Experimental
  description: Administered orally
  arm group label: SKI-G-801(Denfivontinib) 300mg QD
  arm group type: Experimental
  description: Administered orally
  arm group label: SKI-G-801(Denfivontinib) 400mg QD
  arm group type: Experimental
  description: Administered orally
  arm group label: SKI-G-801(Denfivontinib) 500mg QD
  arm group type: Experimental
  description: Administered orally
  intervention type: Drug
  intervention name: SKI-G-801
  description: Oral SKI-G-801(Denfivontinib) will be daily administered based on dose level.
  arm group label: SKI-G-801(Denfivontinib) 100mg QD
  arm group label: SKI-G-801(Denfivontinib) 150mg QD
  arm group label: SKI-G-801(Denfivontinib) 225mg QD
  arm group label: SKI-G-801(Denfivontinib) 300mg QD
  arm group label: SKI-G-801(Denfivontinib) 400mg QD
  arm group label: SKI-G-801(Denfivontinib) 500mg QD
  other name: Denfivontinib
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: No
  last name: MinKi Kang
  phone: +820316287624
  email: mkkang@oscotec.com
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  country: Korea, Republic of
  responsible party type: Sponsor
  mesh term: Neoplasms