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/NCT06023758</url>
    </required_header>
    <id_info>
      <org_study_id>KHER2-001</org_study_id>
      <nct_id>NCT06023758</nct_id>
    </id_info>
    <brief_title>Phase 2 Trial of KN026+KN046±XELOX in HER2-positive Locally Advanced GC</brief_title>
    <official_title>A Multicenter II Study to Compare KN026 and KN046 Versus Oxaliplatin, Capecitabine Combined KN026 and KN046 in Patients With HER2-positive Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction Adenocarcinoma.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking University</source>
    <oversight_info>
      <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 multicenter II study to compare KN026 and KN046 versus Oxaliplatin, Capecitabine&#xD;
        combined KN026 and KN046 in patients with HER2-positive locally advanced resectable gastric&#xD;
        cancer or gastroesophageal junction adenocarcinoma.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping&#xD;
        epitopes of HER2, resulting in dual HER2 signaling blockade.KN046 is a PD-L1 - CTLA-4&#xD;
        bispecific antibody. The trial consists of two groups. All subjects will be treated with&#xD;
        KN026 at 30 mg/kg Q3W in combination with KN046 at 5 mg/kg Q3W in Group 1. If the statistical&#xD;
        hypothesis is not met in Group 1, patients will be enrolled in Group 2. Patients in group 2&#xD;
        will receive KN026+KN046+XELOX.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2025</primary_completion_date>
    <phase>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>pCR rate</measure>
      <time_frame>up to 2 years</time_frame>
      <description>Pathological complete response (pCR) rate (assessed by central pathology laboratory and the site)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Event-free survival (EFS)</measure>
      <time_frame>from enrollment until firstly confirmed and recorded disease progression or death，assessed up to 3 years</time_frame>
      <description>Event-free survival (assessed by the investigator per RECIST v1.1 criteria)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease-free survival (DFS)</measure>
      <time_frame>from the start of surgery to disease recurrence or death (for any reason)，assessed up to 3 years</time_frame>
      <description>Disease-free survival (assessed by the investigator per RECIST v1.1 criteria)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>overall survival (OS)</measure>
      <time_frame>From date of randomization until the date of death from any cause, assessed up to 5 years</time_frame>
      <description>overall survival</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">18</enrollment>
    <condition>HER2-positive Locally Advanced Resectable Gastric Cancer</condition>
    <arm_group>
      <arm_group_label>KN026 combined with KN046</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>KN026 combined with KN046</description>
    </arm_group>
    <arm_group>
      <arm_group_label>KN026，KN046 and XELOX</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>KN026，KN046 and XELOX</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>KN026</intervention_name>
      <description>KN026：30 mg/kg Q3W</description>
      <arm_group_label>KN026 combined with KN046</arm_group_label>
      <arm_group_label>KN026，KN046 and XELOX</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>KN046</intervention_name>
      <description>KN046：5 mg/kg Q3W</description>
      <arm_group_label>KN026 combined with KN046</arm_group_label>
      <arm_group_label>KN026，KN046 and XELOX</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>XELOX</intervention_name>
      <description>Oxaliplatin 130mg/m2 d1，Capecitabine 1000mg/m2 d1-14，Q3W</description>
      <arm_group_label>KN026，KN046 and XELOX</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The subject can understand the informed consent, voluntarily participate and sign the&#xD;
               informed consent ;&#xD;
  &#xD;
            -  Subjects are older than or equal to 18 years old and younger than or equal to 75 years&#xD;
               old on the day of signing the informed consent；&#xD;
  &#xD;
            -  Histologically or cytologically confirmed, locally advanced HER2-positive gastric&#xD;
               cancer or gastroesophageal junction adenocarcinoma.&#xD;
  &#xD;
            -  ECOG score 0 or 1;&#xD;
  &#xD;
            -  Left ventricular ejection fraction (LVEF) ≥ 50% at baseline as determined by either&#xD;
               ECHO (preferred) or MUGA;&#xD;
  &#xD;
            -  Liver function met the following criteria within 7 days prior to initial&#xD;
               administration:&#xD;
  &#xD;
          Total bilirubin ≤1.0x ULN (Gilbert's syndrome, or total bilirubin ≤1.5x ULN in liver&#xD;
          metastases); Aminotransferase (ALT/AST) ≤1.5x ULN (liver metastatic subjects ≤3xULN);&#xD;
          -Renal function within 7 days prior to initial administration: serum creatinine ≤1.5x ULN&#xD;
          and serum creatinine clearance ≥60mL/min (according to Cockcroft-Gault Formula&#xD;
          calculation);&#xD;
  &#xD;
            -  Bone marrow function met the following criteria within 7 days prior to initial&#xD;
               administration: Hemoglobin ≥90 g/L; Neutrophil absolute count ≥1.5 x 109/L; Platelet&#xD;
               count ≥100x 109/L; INR or PT≤1.5x ULN, and aPTT≤ 1.5x ULN;&#xD;
  &#xD;
            -  Life expectancy &gt;3 months;&#xD;
  &#xD;
            -  The subjects are able and willing to follow the visits, treatment plans, laboratory&#xD;
               tests, and other study-related procedures specified in the study protocol&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Existence of other active malignant tumors within 5 years or at the same time. Plan to&#xD;
               perform or have undergone an organ or bone marrow transplant. Myocardial infarction&#xD;
               and poorly controlled arrhythmias occurred within 6 months prior to the first dose.&#xD;
  &#xD;
            -  Existence of grade III - IV cardiac disorders defined by the NYHA or echocardiogram&#xD;
               shows: LVEF (left ventricular ejection fraction) &lt; 50%.&#xD;
  &#xD;
            -  Human immunodeficiency virus (HIV) infection.&#xD;
  &#xD;
            -  Patients with active tuberculosis.&#xD;
  &#xD;
            -  Patient with previous or current interstitial pneumonia, pneumoconiosis, radiation&#xD;
               pneumonitis, drug-associated pneumonia, severely impaired lung function, etc.&#xD;
  &#xD;
            -  Patients who have previously received other antibody/drug treatments for immune&#xD;
               checkpoints, such as PD-1, PD-L1, and CTLA4 treatments.&#xD;
  &#xD;
            -  Have diseases that may increase the risk of participating in the study and using the&#xD;
               study medications, or other severe, acute, and chronic diseases and therefore are&#xD;
               judged by the investigator to be unsuitable for clinical studies.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 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>Stomach 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/NCT06023758
  org study id: KHER2-001
  nct id: NCT06023758
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a multicenter II study to compare KN026 and KN046 versus Oxaliplatin, Capecitabine
        combined KN026 and KN046 in patients with HER2-positive locally advanced resectable gastric
        cancer or gastroesophageal junction adenocarcinoma.
  KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping
        epitopes of HER2, resulting in dual HER2 signaling blockade.KN046 is a PD-L1 - CTLA-4
        bispecific antibody. The trial consists of two groups. All subjects will be treated with
        KN026 at 30 mg/kg Q3W in combination with KN046 at 5 mg/kg Q3W in Group 1. If the statistical
        hypothesis is not met in Group 1, patients will be enrolled in Group 2. Patients in group 2
        will receive KN026+KN046+XELOX.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: pCR rate
  time frame: up to 2 years
  description: Pathological complete response (pCR) rate (assessed by central pathology laboratory and the site)
  measure: Event-free survival (EFS)
  time frame: from enrollment until firstly confirmed and recorded disease progression or death，assessed up to 3 years
  description: Event-free survival (assessed by the investigator per RECIST v1.1 criteria)
  measure: Disease-free survival (DFS)
  time frame: from the start of surgery to disease recurrence or death (for any reason)，assessed up to 3 years
  description: Disease-free survival (assessed by the investigator per RECIST v1.1 criteria)
  measure: overall survival (OS)
  time frame: From date of randomization until the date of death from any cause, assessed up to 5 years
  description: overall survival
  arm group label: KN026 combined with KN046
  arm group type: Experimental
  description: KN026 combined with KN046
  arm group label: KN026，KN046 and XELOX
  arm group type: Experimental
  description: KN026，KN046 and XELOX
  intervention type: Drug
  intervention name: KN026
  description: KN026：30 mg/kg Q3W
  arm group label: KN026 combined with KN046
  arm group label: KN026，KN046 and XELOX
  intervention type: Drug
  intervention name: KN046
  description: KN046：5 mg/kg Q3W
  arm group label: KN026 combined with KN046
  arm group label: KN026，KN046 and XELOX
  intervention type: Drug
  intervention name: XELOX
  description: Oxaliplatin 130mg/m2 d1，Capecitabine 1000mg/m2 d1-14，Q3W
  arm group label: KN026，KN046 and XELOX
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Stomach Neoplasms