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/NCT06012708</url>
    </required_header>
    <id_info>
      <org_study_id>NCCKN-101</org_study_id>
      <nct_id>NCT06012708</nct_id>
    </id_info>
    <brief_title>Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KN510, KN713</brief_title>
    <official_title>An Open-label, Dose-escalation and Dose-finding, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KN510, KN713 as Combination Therapy in Patients With Advanced Solid Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>New Cancer Cure-Bio Co.,Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>New Cancer Cure-Bio Co.,Ltd.</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>
        To evaluate the safety and tolerability of the combination therapy of KN510 and KN713 and&#xD;
        determine the MTD and RP2D in patients with advanced solid tumors.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        It is expected that KN510 and KN713 will broaden the range of target patient groups and&#xD;
        overcome resistance to the drugs in an innovative manner by targeting the common metabolic&#xD;
        process of cancer cells, unlike existing targeted therapies whose application is limited&#xD;
        depending on the presence of specific mutation and combination of mutations as they mainly&#xD;
        target a single tyrosine kinase.&#xD;
  &#xD;
        In this study, the safety and tolerability of combination therapy of KN510 and KN713,&#xD;
        including the dose limiting toxicity (DLT) and maximum tolerated dose (MTD), will be&#xD;
        evaluated in patients with advance solid tumors and based on this, the recommended phase 2&#xD;
        dose (RP2D) will be determined.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">September 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>DLT(dose limiting toxicity)</measure>
      <time_frame>Until 28 days from the first IP administration</time_frame>
      <description>DLTs will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) ver. 5.0, and defined as CTCAE Grade ≥3 ADR(Adverse Drug Reaction)s.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>AEs(Adverse Events)</measure>
      <time_frame>Through study completion, an average of 5 months</time_frame>
      <description>Any clinically significant medical condition or abnormality observed after IP administration will be collected as an AE.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Laboratory tests</measure>
      <time_frame>Through study completion, an average of 5 months</time_frame>
      <description>For collected laboratory test results, changes between before and after IP administration and/or changes in normality/abnormality will be assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Vital signs</measure>
      <time_frame>Through study completion, an average of 5 months</time_frame>
      <description>For collected vital signs results, changes between before and after IP administration and/or changes in normality/abnormality will be assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>ECG(Electrocardiogram)</measure>
      <time_frame>Through study completion, an average of 5 months</time_frame>
      <description>ECG results will be assessed and recorded as normal or abnormal, and any clinically significant changes will be recorded as AEs in the CRF.</description>
    </primary_outcome>
    <other_outcome>
      <measure>AUClast</measure>
      <time_frame>Day 1: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose</time_frame>
      <description>AUClast of KN510 and KN713</description>
    </other_outcome>
    <other_outcome>
      <measure>AUCinf</measure>
      <time_frame>Day 1: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose</time_frame>
      <description>AUCinf of KN510 and KN713</description>
    </other_outcome>
    <other_outcome>
      <measure>Cmax</measure>
      <time_frame>Day 1: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose</time_frame>
      <description>Cmax of KN510 and KN713</description>
    </other_outcome>
    <other_outcome>
      <measure>Tmax</measure>
      <time_frame>Day 1: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose</time_frame>
      <description>Tmax of KN510 and KN713</description>
    </other_outcome>
    <other_outcome>
      <measure>CL/F</measure>
      <time_frame>Day 1: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose</time_frame>
      <description>CL/F of KN510 and KN713</description>
    </other_outcome>
    <other_outcome>
      <measure>Vd/F</measure>
      <time_frame>Day 1: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose</time_frame>
      <description>Vd/F of KN510 and KN713</description>
    </other_outcome>
    <other_outcome>
      <measure>t1/2</measure>
      <time_frame>Day 1: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose</time_frame>
      <description>t1/2 of KN510 and KN713</description>
    </other_outcome>
    <other_outcome>
      <measure>AUCtau,ss</measure>
      <time_frame>Day 22: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose</time_frame>
      <description>AUCtau,ss of KN510 and KN713</description>
    </other_outcome>
    <other_outcome>
      <measure>Cmax,ss</measure>
      <time_frame>Day 22: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose</time_frame>
      <description>Cmax,ss of KN510 and KN713</description>
    </other_outcome>
    <other_outcome>
      <measure>Cmin,ss</measure>
      <time_frame>Day 22: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose</time_frame>
      <description>Cmin,ss of KN510 and KN713</description>
    </other_outcome>
    <other_outcome>
      <measure>Cav,ss</measure>
      <time_frame>Day 22: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose</time_frame>
      <description>Cav,ss of KN510 and KN713</description>
    </other_outcome>
    <other_outcome>
      <measure>peak-trough fluctuation (PTF)</measure>
      <time_frame>Day 22: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose</time_frame>
      <description>peak-trough fluctuation (PTF) of KN510 and KN713</description>
    </other_outcome>
    <other_outcome>
      <measure>Tmax,ss</measure>
      <time_frame>Day 22: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose</time_frame>
      <description>Tmax,ss of KN510 and KN713</description>
    </other_outcome>
    <other_outcome>
      <measure>CLss/F</measure>
      <time_frame>Day 22: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose</time_frame>
      <description>CLss/F of KN510 and KN713</description>
    </other_outcome>
    <other_outcome>
      <measure>Vd,ss/F</measure>
      <time_frame>Day 22: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose</time_frame>
      <description>Vd,ss/F of KN510 and KN713</description>
    </other_outcome>
    <other_outcome>
      <measure>t1/2,ss</measure>
      <time_frame>Day 22: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose</time_frame>
      <description>t1/2,ss of KN510 and KN713</description>
    </other_outcome>
    <other_outcome>
      <measure>accumulation ratio</measure>
      <time_frame>Day 22: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose</time_frame>
      <description>accumulation ratio of KN510 and KN713</description>
    </other_outcome>
    <other_outcome>
      <measure>Objective response rate (ORR)*</measure>
      <time_frame>Through study completion, an average of 5 months</time_frame>
      <description>Proportion of subjects with best overall response (BOR) of complete response (CR) or partial response (PR) *ORR = CR + PR</description>
    </other_outcome>
    <other_outcome>
      <measure>Disease control rate (DCR)**</measure>
      <time_frame>Through study completion, an average of 5 months</time_frame>
      <description>Proportion of subjects with BOR of CR, PR or stable disease (SD)&#xD;
  **DCR = CR + PR + SD</description>
    </other_outcome>
    <other_outcome>
      <measure>Exploratory Efficacy Endpoints [DOR]</measure>
      <time_frame>6 and 12 months</time_frame>
      <description>Time from initial assessment of confirmed CR or PR to initial assessment of confirmed PD</description>
    </other_outcome>
    <other_outcome>
      <measure>Progression free survival (PFS)</measure>
      <time_frame>6 and 12 months</time_frame>
      <description>Time from the start of IP treatment to PD per RECIST v1.1 or death from any cause, whichever occurs first</description>
    </other_outcome>
    <other_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>6 and 12 months</time_frame>
      <description>Time from the start of IP treatment to death from any cause</description>
    </other_outcome>
    <other_outcome>
      <measure>Target tumor size</measure>
      <time_frame>Through study completion, an average of 5 months</time_frame>
      <description>Maximum percentage change in the sum of longest diameters of target lesions</description>
    </other_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Advanced Solid Tumors</condition>
    <arm_group>
      <arm_group_label>Dose Level 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Dose Level 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Dose Level 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Dose Level 4</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>KN510 60mg/day + KN713 60mg/day</intervention_name>
      <description>Once daily with 28 days (4 weeks) as one cycle.</description>
      <arm_group_label>Dose Level 1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>KN510 120mg/day + KN713 60mg/day</intervention_name>
      <description>Once daily with 28 days (4 weeks) as one cycle.</description>
      <arm_group_label>Dose Level 2</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>KN510 120mg/day + KN713 90mg/day</intervention_name>
      <description>Once daily with 28 days (4 weeks) as one cycle.</description>
      <arm_group_label>Dose Level 3</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>KN510 120mg/day + KN713 120mg/day</intervention_name>
      <description>Once daily with 28 days (4 weeks) as one cycle.</description>
      <arm_group_label>Dose Level 4</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male and female adults aged 19-75 years&#xD;
  &#xD;
            2. Unresectable advanced or metastatic solid tumors that are confirmed as progressive&#xD;
               disease (PD) after the standard of care currently known to have clinical benefits, or&#xD;
               for which no currently available standard therapies exist due to intolerance,&#xD;
               ineligibility, rejection, etc.&#xD;
  &#xD;
            3. At least one measurable lesion per RECIST ver1.1&#xD;
  &#xD;
            4. The Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1&#xD;
  &#xD;
            5. Life expectancy of at least 12 weeks&#xD;
  &#xD;
            6. Confirmed adequate hematologic, renal, and hepatic functions according to the&#xD;
               following criteria (Laboratory tests may be repeated once during the screening&#xD;
               period):&#xD;
  &#xD;
               A. Hematological function&#xD;
  &#xD;
                 -  Absolute neutrophil count (ANC) ≥1,500/μL&#xD;
  &#xD;
                 -  Hemoglobin ≥9 g/dL&#xD;
  &#xD;
                 -  Platelet count ≥100,000/μL&#xD;
  &#xD;
               B. Renal function: Creatinine clearance (CrCl*) &gt;60 mL/min&#xD;
  &#xD;
               *Cockcroft-Gault equation&#xD;
  &#xD;
               C. Hepatic function&#xD;
  &#xD;
                 -  Aspartate aminotransferase (AST) ≤3.0 × ULN&#xD;
  &#xD;
                 -  Alanine aminotransferase (ALT) ≤3.0 × ULN (AST/ALT ≤5 × ULN, if hepatic&#xD;
                    metastasis is confirmed)&#xD;
  &#xD;
                 -  Total bilirubin ≤1.5 × ULN (with the exception of confirmed Gilbert's syndrome)&#xD;
  &#xD;
               D. Coagulation function: Prothrombin time international normalized ratio (PT INR) and&#xD;
               activated partial thromboplastin time (aPTT) ≤1.5 × ULN&#xD;
  &#xD;
            7. Voluntary written consent to participate in this study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Hypersensitivity to the active ingredient or excipients of KN510 or KN713&#xD;
  &#xD;
            2. Any of the following medical (surgical) history or comorbidities at the screening&#xD;
               visit:&#xD;
  &#xD;
               A. Major surgery that requires general anesthesia or a respiratory assist device&#xD;
               within 4 weeks prior to screening (within 2 weeks for video-assisted thoracoscopic&#xD;
               surgery [VATS] or open-and-closed [ONC] surgery)&#xD;
  &#xD;
               B. Clinically significant arrhythmia, acute myocardial infarction, unstable angina, or&#xD;
               NYHA Grade Ⅲ or Ⅳ heart failure within 24 weeks prior to screening&#xD;
  &#xD;
               C. Pulmonary thrombosis, deep vein thrombosis, or bronchial asthma, obstructive&#xD;
               pulmonary disease or other life-threatening severe lung disorder (e.g., acute&#xD;
               respiratory distress syndrome, lung failure) considered ineligible for participation&#xD;
               in the study within 24 weeks prior to screening&#xD;
  &#xD;
               D. Grade 3 or higher active infectious conditions which require systemic antibiotics,&#xD;
               antivirals, etc. within 2 weeks prior to screening&#xD;
  &#xD;
               E. Clinically significantly symptomatic or uncontrolled central nervous system or&#xD;
               brain metastases at screening (except for patients who have discontinued systemic&#xD;
               corticosteroid treatment at least 4 weeks prior to baseline and have been stable for&#xD;
               at least 4 weeks)&#xD;
  &#xD;
               F. Hematologic malignancy including lymphoma at screening&#xD;
  &#xD;
               G. Uncontrolled hypertension (systolic blood pressure [SBP]/diastolic blood pressure&#xD;
               [DBP] ≥160/100 mmHg) at screening&#xD;
  &#xD;
               H. Parkinson's disease, parkinsonian symptoms, tremors, restless leg syndrome, and&#xD;
               other related movement disorders at screening&#xD;
  &#xD;
               I. Active hepatitis B* or C† at screening&#xD;
  &#xD;
               * Defined as HBsAg positive at screening; patients on stable antiviral regimen may&#xD;
               participate&#xD;
  &#xD;
               † Defined as HCV Ab positive at screening; patients who test negative for HCV RNA may&#xD;
               participate&#xD;
  &#xD;
               J. Known human immunodeficiency virus (HIV) infection&#xD;
  &#xD;
               K. Difficulty (e.g., problem swallowing) in oral administration of KN510 and KN713 or&#xD;
               disease (celiac disease, Crohn's disease, or intestinal resection which is clinically&#xD;
               significant or impacts absorption) which impacts absorption at screening&#xD;
  &#xD;
               L. History or suspected symptoms of gastroesophageal reflux disease (GERD) such as&#xD;
               gastric ulcer, duodenal ulcer, and reflux esophagitis at screening&#xD;
  &#xD;
               M. History of autoimmune diseases at screening&#xD;
  &#xD;
               N. Deemed ineligible for the study for having a comorbidity that is uncontrolled or&#xD;
               requires treatment&#xD;
  &#xD;
            3. Prior treatment with any of the following medications within 2 weeks prior to&#xD;
               screening&#xD;
  &#xD;
               A. Proton pump inhibitors (PPIs) other than the IP&#xD;
  &#xD;
               B. Strong CYP2C19 inducers: Rifampicin, Apalutamide, Rifamycin, Rifaximin, Rifapentine&#xD;
  &#xD;
               C. Strong CYP2C19 inhibitors: Fluvoxamine, Ticlopidine, Chloramphenicol, Delavirdine,&#xD;
               Gemfibrozil, Stiripentol, Fluoxetine, Imipramine, Clomipramine, Lansoprazole,&#xD;
               Isoniazid, Zafirlukast, Tioconazole, Miconazole&#xD;
  &#xD;
               D. CYP2C19 substrates: Clopidogrel, Citalopram, Cilostazol, Phenytoin, Diazepam&#xD;
  &#xD;
               E. Vitamin K antagonists: Warfarin, Dicoumarol, Phenindione, Phenprocoumon,&#xD;
               Acenocoumarol, Ethyl biscoumacetate, Fluindione, Clorindione, Diphenadione,&#xD;
               Tioclomarol&#xD;
  &#xD;
               F. Antiretrovirals: Rilpivirine-containing products, Atazanavir, Nelfinavir,&#xD;
               Saquinavir&#xD;
  &#xD;
               G. High dose Methotrexate (≥1000 mg/m2)&#xD;
  &#xD;
               H. Digoxin&#xD;
  &#xD;
               I. Cefditoren, Cefuroxime&#xD;
  &#xD;
               J. Levoketoconazole&#xD;
  &#xD;
               K. St John's Wort&#xD;
  &#xD;
               L. Bromopride, Metoclopramide&#xD;
  &#xD;
               M. Other anti-cancer therapies (chemotherapy, radiotherapy, immunotherapy, targeted&#xD;
               therapy, hormone therapy, etc. other than the IP) which could impact the efficacy&#xD;
               results during the study (However, local radiotherapy to alleviate ostalgia, bronchial&#xD;
               obstruction, skin lesion, etc. are permitted. The total irradiation dose must be&#xD;
               within the site-specific reference range for palliative therapy, and irradiation sites&#xD;
               must be excluded from the tumor assessment.)&#xD;
  &#xD;
               N. Requiring continued treatment with systemic corticosteroids at a dose of prednisone&#xD;
               &gt;10 mg/day or equivalent (with exceptions of topical use such as intra-articular,&#xD;
               intranasal, intraocular, and inhalational administration and temporary use for&#xD;
               treatment and prevention of allergic reactions to a contrast agent or AEs [e.g.,&#xD;
               vomiting])&#xD;
  &#xD;
            4. Pregnant or lactating women, or women of childbearing potential and men who are&#xD;
               unwilling to remain abstinent or use adequate methods of contraception* during the&#xD;
               study and for 3 months after IP administration&#xD;
  &#xD;
               * Adequate methods of contraception:&#xD;
  &#xD;
                 -  Hormonal contraceptives&#xD;
  &#xD;
                 -  Placement of an intrauterine device or intrauterine system&#xD;
  &#xD;
                 -  Surgical sterilization (vasectomy, tubal ligation, etc.)&#xD;
  &#xD;
            5. Received/Used another investigational agent/device within 4 weeks (or 5 half-lives)&#xD;
               prior to screening&#xD;
  &#xD;
            6. Ineligibility or inability to participate in the study in the judgment of the&#xD;
               investigator&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Joon Hee Kang, Ph.D.</last_name>
      <phone>+8231-920-2227</phone>
      <email>wnsl2820@gmail.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 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>Advanced solid tumors</keyword>
    <!-- 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/NCT06012708
  org study id: NCCKN-101
  nct id: NCT06012708
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate the safety and tolerability of the combination therapy of KN510 and KN713 and
        determine the MTD and RP2D in patients with advanced solid tumors.
  It is expected that KN510 and KN713 will broaden the range of target patient groups and
        overcome resistance to the drugs in an innovative manner by targeting the common metabolic
        process of cancer cells, unlike existing targeted therapies whose application is limited
        depending on the presence of specific mutation and combination of mutations as they mainly
        target a single tyrosine kinase.
  
        In this study, the safety and tolerability of combination therapy of KN510 and KN713,
        including the dose limiting toxicity (DLT) and maximum tolerated dose (MTD), will be
        evaluated in patients with advance solid tumors and based on this, the recommended phase 2
        dose (RP2D) will be determined.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: DLT(dose limiting toxicity)
  time frame: Until 28 days from the first IP administration
  description: DLTs will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) ver. 5.0, and defined as CTCAE Grade ≥3 ADR(Adverse Drug Reaction)s.
  measure: AEs(Adverse Events)
  time frame: Through study completion, an average of 5 months
  description: Any clinically significant medical condition or abnormality observed after IP administration will be collected as an AE.
  measure: Laboratory tests
  time frame: Through study completion, an average of 5 months
  description: For collected laboratory test results, changes between before and after IP administration and/or changes in normality/abnormality will be assessed.
  measure: Vital signs
  time frame: Through study completion, an average of 5 months
  description: For collected vital signs results, changes between before and after IP administration and/or changes in normality/abnormality will be assessed.
  measure: ECG(Electrocardiogram)
  time frame: Through study completion, an average of 5 months
  description: ECG results will be assessed and recorded as normal or abnormal, and any clinically significant changes will be recorded as AEs in the CRF.
  measure: AUClast
  time frame: Day 1: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose
  description: AUClast of KN510 and KN713
  measure: AUCinf
  time frame: Day 1: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose
  description: AUCinf of KN510 and KN713
  measure: Cmax
  time frame: Day 1: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose
  description: Cmax of KN510 and KN713
  measure: Tmax
  time frame: Day 1: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose
  description: Tmax of KN510 and KN713
  measure: CL/F
  time frame: Day 1: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose
  description: CL/F of KN510 and KN713
  measure: Vd/F
  time frame: Day 1: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose
  description: Vd/F of KN510 and KN713
  measure: t1/2
  time frame: Day 1: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose
  description: t1/2 of KN510 and KN713
  measure: AUCtau,ss
  time frame: Day 22: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose
  description: AUCtau,ss of KN510 and KN713
  measure: Cmax,ss
  time frame: Day 22: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose
  description: Cmax,ss of KN510 and KN713
  measure: Cmin,ss
  time frame: Day 22: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose
  description: Cmin,ss of KN510 and KN713
  measure: Cav,ss
  time frame: Day 22: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose
  description: Cav,ss of KN510 and KN713
  measure: peak-trough fluctuation (PTF)
  time frame: Day 22: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose
  description: peak-trough fluctuation (PTF) of KN510 and KN713
  measure: Tmax,ss
  time frame: Day 22: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose
  description: Tmax,ss of KN510 and KN713
  measure: CLss/F
  time frame: Day 22: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose
  description: CLss/F of KN510 and KN713
  measure: Vd,ss/F
  time frame: Day 22: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose
  description: Vd,ss/F of KN510 and KN713
  measure: t1/2,ss
  time frame: Day 22: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose
  description: t1/2,ss of KN510 and KN713
  measure: accumulation ratio
  time frame: Day 22: 0(pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post-dose
  description: accumulation ratio of KN510 and KN713
  measure: Objective response rate (ORR)*
  time frame: Through study completion, an average of 5 months
  description: Proportion of subjects with best overall response (BOR) of complete response (CR) or partial response (PR) *ORR = CR + PR
  measure: Disease control rate (DCR)**
  time frame: Through study completion, an average of 5 months
  description: Proportion of subjects with BOR of CR, PR or stable disease (SD)
  **DCR = CR + PR + SD
  measure: Exploratory Efficacy Endpoints [DOR]
  time frame: 6 and 12 months
  description: Time from initial assessment of confirmed CR or PR to initial assessment of confirmed PD
  measure: Progression free survival (PFS)
  time frame: 6 and 12 months
  description: Time from the start of IP treatment to PD per RECIST v1.1 or death from any cause, whichever occurs first
  measure: Overall survival (OS)
  time frame: 6 and 12 months
  description: Time from the start of IP treatment to death from any cause
  measure: Target tumor size
  time frame: Through study completion, an average of 5 months
  description: Maximum percentage change in the sum of longest diameters of target lesions
  arm group label: Dose Level 1
  arm group type: Experimental
  arm group label: Dose Level 2
  arm group type: Experimental
  arm group label: Dose Level 3
  arm group type: Experimental
  arm group label: Dose Level 4
  arm group type: Experimental
  intervention type: Drug
  intervention name: KN510 60mg/day + KN713 60mg/day
  description: Once daily with 28 days (4 weeks) as one cycle.
  arm group label: Dose Level 1
  intervention type: Drug
  intervention name: KN510 120mg/day + KN713 60mg/day
  description: Once daily with 28 days (4 weeks) as one cycle.
  arm group label: Dose Level 2
  intervention type: Drug
  intervention name: KN510 120mg/day + KN713 90mg/day
  description: Once daily with 28 days (4 weeks) as one cycle.
  arm group label: Dose Level 3
  intervention type: Drug
  intervention name: KN510 120mg/day + KN713 120mg/day
  description: Once daily with 28 days (4 weeks) as one cycle.
  arm group label: Dose Level 4
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Joon Hee Kang, Ph.D.
  phone: +8231-920-2227
  email: wnsl2820@gmail.com
  responsible party type: Sponsor