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/NCT06022250</url>
    </required_header>
    <id_info>
      <org_study_id>JS207-001-I</org_study_id>
      <nct_id>NCT06022250</nct_id>
    </id_info>
    <brief_title>The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor</brief_title>
    <official_title>A Phase I Study to Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Junshi Bioscience Co., Ltd.</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Sponsor GmbH</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Shanghai Junshi Bioscience Co., Ltd.</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 Phase I open-label, multicenter study to evaluate the safety, tolerability,&#xD;
        pharmacokinetics (PK),Pharmacodynamic characteristics, immunogenicity and antitumor activity&#xD;
        of JS207 in patients with advanced malignant tumor. The Recommended dose for phase II trial&#xD;
        （RP2D） will be determined based on the safety, tolerability, pharmacokinetics.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">March 15, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 15, 2025</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>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Dose-limiting toxicity （DLT）、adverse event（AE）</measure>
      <time_frame>2 Years</time_frame>
      <description>Incidence and severity of DLT, adverse events (AE), Abnormal changes in laboratory and other tests with clinical significance</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum tolerated dose (MTD),RP2D</measure>
      <time_frame>2 Years</time_frame>
      <description>Maximum tolerated dose (MTD), Recommended dose for phase II trial</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Peak concentration（Cmax）</measure>
      <time_frame>2 years</time_frame>
      <description>The highest plasma drug concentration that can be achieved after medication</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to peak（Tmax）</measure>
      <time_frame>2 years</time_frame>
      <description>After a single dose, the time of peak blood concentration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Elimination half life（t1/2）</measure>
      <time_frame>2 years</time_frame>
      <description>The time it takes the blood to reduce the concentration of the drug to half</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression free survival(PFS)</measure>
      <time_frame>2 years</time_frame>
      <description>The time from first dose to Disease progression or death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>2 years</time_frame>
      <description>The time from first dose to death from any cause</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immunogenicity</measure>
      <time_frame>2 years</time_frame>
      <description>Incidence of Anti-Drug Antibody (ADA)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1)</measure>
      <time_frame>2 years</time_frame>
      <description>Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">162</enrollment>
    <condition>Advanced Malignant Tumor</condition>
    <arm_group>
      <arm_group_label>JS207</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>JS207</intervention_name>
      <description>Patients will receive specific dose of JS207 via intravenous infusion.</description>
      <arm_group_label>JS207</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          1. Patients with advanced malignant tumor confirmed by histology or pathology, failed by&#xD;
          standard treatment, no standard treatment or no standard treatment is applicable; 2 .&#xD;
          Eastern Cooperative Oncology Group (ECOG) 0 or 1; 3. Life expectancy ≥ 12 weeks; 4. At&#xD;
          least one measurable lesion according to RECIST 1.1; 5. Adequate organ function;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. central nervous system metastasis&#xD;
  &#xD;
            2. There is a pleural, abdominal or pericardial effusion that is clinically symptomatic&#xD;
               or requires repeated management (puncture or drainage, etc.)&#xD;
  &#xD;
            3. Images in screening showed that the tumor surrounded important blood vessels or had&#xD;
               obvious necrosis and voids, and the investigators believed that it might cause&#xD;
               bleeding risk.&#xD;
  &#xD;
            4. The presence of severe, unhealed or open wounds, active ulcers, or untreated&#xD;
               fractures.&#xD;
  &#xD;
            5. A history of significant bleeding tendency or severe coagulopathy.&#xD;
  &#xD;
            6. The presence of poorly controlled hypertension.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Kai Xu</last_name>
      <phone>86 13761020175</phone>
      <email>kai_xu@junshipharma.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Affiliated Cancer Hospital of Shandong First Medical University</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <zip>250117</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Jinming Yu, M.D.</last_name>
        <phone>86531-67626971</phone>
        <email>sdyujinming@126.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 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>
    <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/NCT06022250
  org study id: JS207-001-I
  nct id: NCT06022250
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a Phase I open-label, multicenter study to evaluate the safety, tolerability,
        pharmacokinetics (PK),Pharmacodynamic characteristics, immunogenicity and antitumor activity
        of JS207 in patients with advanced malignant tumor. The Recommended dose for phase II trial
        （RP2D） will be determined based on the safety, tolerability, pharmacokinetics.
  allocation: N/A
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Dose-limiting toxicity （DLT）、adverse event（AE）
  time frame: 2 Years
  description: Incidence and severity of DLT, adverse events (AE), Abnormal changes in laboratory and other tests with clinical significance
  measure: Maximum tolerated dose (MTD),RP2D
  time frame: 2 Years
  description: Maximum tolerated dose (MTD), Recommended dose for phase II trial
  measure: Peak concentration（Cmax）
  time frame: 2 years
  description: The highest plasma drug concentration that can be achieved after medication
  measure: Time to peak（Tmax）
  time frame: 2 years
  description: After a single dose, the time of peak blood concentration
  measure: Elimination half life（t1/2）
  time frame: 2 years
  description: The time it takes the blood to reduce the concentration of the drug to half
  measure: Progression free survival(PFS)
  time frame: 2 years
  description: The time from first dose to Disease progression or death
  measure: Overall survival (OS)
  time frame: 2 years
  description: The time from first dose to death from any cause
  measure: Immunogenicity
  time frame: 2 years
  description: Incidence of Anti-Drug Antibody (ADA)
  measure: Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1)
  time frame: 2 years
  description: Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR)
  arm group label: JS207
  arm group type: Experimental
  intervention type: Drug
  intervention name: JS207
  description: Patients will receive specific dose of JS207 via intravenous infusion.
  arm group label: JS207
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Kai Xu
  phone: 86 13761020175
  email: kai_xu@junshipharma.com
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Neoplasms
  sharing ipd: No