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/NCT05989997</url>
    </required_header>
    <id_info>
      <org_study_id>SN-SNA002-2023-001</org_study_id>
      <nct_id>NCT05989997</nct_id>
    </id_info>
    <brief_title>Phase I Clinical Trial of 68Ga-NOTA-SNA002</brief_title>
    <official_title>Phase I Clinical Trial of Evaluating 68Ga-NOTA-SNA002 for the Safety Tolerance, Radiation Absorbed Dose and Dosimetry in Patients With Solid Tumor</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>SmartNuclide Biopharma</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>SmartNuclide Biopharma</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The clinical trial was a single-center, dose-increasing, open trial.In this clinical trial,&#xD;
        68Ga-NOTA-SNA002 was injected intravenously to observe its safety tolerance, radiation&#xD;
        absorption dose, distribution characteristics, etc. in patients with solid tumors.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study consisted of four phases: screening period , baseline period , trial period and&#xD;
        safety follow-up period .&#xD;
  &#xD;
        Screening period 2 weeks before the start of the trial, all eligible subjects were selected&#xD;
        to participate in the clinical trial. The informed consent signed by the subjects is required&#xD;
        before performing all the examinations in this clinical trial.&#xD;
  &#xD;
        Baseline period The admission criteria were checked again, and the subjects were enrolled on&#xD;
        the same day after the check.&#xD;
  &#xD;
        Trial period Including drug administration, blood collection, image collection and&#xD;
        pathological tissue collection.&#xD;
  &#xD;
        Safe follow-up period All adverse events and drug combinations are processed and recorded&#xD;
        during this period.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2023</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>Single Group Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Safety of administration(Vital signs)</measure>
      <time_frame>up to 7 days</time_frame>
      <description>The safety of administration will be evaluated based on the assessments of blood pressure, heart rate, respiration and body temperature before and after administration(% of cases with abnormal findings relative to baseline).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Laboratory examination</measure>
      <time_frame>up to 7 days</time_frame>
      <description>such as blood routine, blood biochemistry, urine routine, coagulation function, etc., to evaluate the changes of laboratory examination of subjects before and after administration</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of adverse events</measure>
      <time_frame>through study completion, an average of 1 month</time_frame>
      <description>The incident and severity of adverse events per CTCAE V5.0 criteria will be recorded following dose of 68Ga-NOTA-SNA002.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Biological distribution characteristics</measure>
      <time_frame>60 minutes ~120 minutes after administration</time_frame>
      <description>Description of biodistribution patterns of 68Ga-NOTA-SNA002 on PET</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Anti-SNA002 anti-antibody</measure>
      <time_frame>up to 1 month</time_frame>
      <description>By analyzing anti-SNA002 anti-drug antibody positive rate.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in whole blood and serum radioactive dose</measure>
      <time_frame>60 minutes after Blood sampling</time_frame>
      <description>Measurement of 68Ga Radiation exposure in whole blood and serum after administration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Standardized uptake values based on whole-body PET imaging</measure>
      <time_frame>1 month</time_frame>
      <description>Analyzing whole body PET images，Define area of interest (ROI) and/or volume of Interest (VOI), calculate standardized uptake values (SUVmax, SUVmean, etc.)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Radiation absorbed dose of major organs</measure>
      <time_frame>1 month</time_frame>
      <description>Calculation of the radiation dose for each vital organ by means of radiation uptake values</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">28</enrollment>
    <condition>Solid Tumor</condition>
    <condition>Positron-Emission Tomography(PET)</condition>
    <arm_group>
      <arm_group_label>dose escalation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>4 subgroups mass dose escalation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>68Ga-NOTA-SNA002</intervention_name>
      <description>68Ga-NOTA-SNA002 should be injected intravenously slowly for no less than 1min.</description>
      <arm_group_label>dose escalation</arm_group_label>
      <other_name>Positron Emission Tomography</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18-75 years old (including boundary values);&#xD;
  &#xD;
            2. Those who have behavioral capacity, voluntarily participate in this clinical study,&#xD;
               and sign an informed consent form (ICF);&#xD;
  &#xD;
            3. Physical condition (ECOG) score 0-2 points;&#xD;
  &#xD;
            4. Basal heart rate 60~100 beats/min (including the boundary value, which refers to the&#xD;
               seated heart rate of the patient in a calm state);&#xD;
  &#xD;
            5. Blood pressure measurements &lt; High blood pressure level 1 (includes a history of high&#xD;
               blood pressure, systolic blood pressure treated with exercise or medication; 140 and&#xD;
               diastolic blood pressure&lt; 90mmHg); Specialty situation&#xD;
  &#xD;
            6. Patients with confirmed solid tumors (including but not limited to non-small cell lung&#xD;
               cancer, breast cancer, head and neck squamous cell carcinoma, malignant melanoma) with&#xD;
               or without metastatic tumors;&#xD;
  &#xD;
            7. Patients whose imaging findings indicate that at least one target lesion is measurable&#xD;
               and can be biopsied (CT, MRI, or 18F-FDG PET-CT results are acceptable);&#xD;
  &#xD;
            8. Pathological findings were obtained within the previous 1 year.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients who are unable to perform visits or undergo relevant examinations, operations&#xD;
               or biopsies in accordance with the clinical trial protocol;&#xD;
  &#xD;
            2. Poor nutritional status, screening BMI&lt; 18.5, can not tolerate the test;&#xD;
  &#xD;
            3. People with known or suspected evidence of active autoimmune disease (e.g., vitiligo,&#xD;
               diabetes, residual hypothyroidism due to autoimmune disease requiring hormone&#xD;
               replacement therapy only, autoimmunological disease such as psoriasis that does not&#xD;
               require systemic treatment), Or diseases that are not expected to recur in the absence&#xD;
               of external triggers are allowed to be included in the study);&#xD;
  &#xD;
            4. Patients who take large doses of hormones, such as hydrocortisone or 5mg prednisone in&#xD;
               the morning and hydrocortisone or 2.5mg prednisone in the evening;&#xD;
  &#xD;
            5. Patients with serious diseases or other malignant tumors (except those who have been&#xD;
               cured one year ago or do not require additional treatment);&#xD;
  &#xD;
            6. People with known severe allergy to 68Ga-NOTA-SNA002, similar drugs or excipients.&#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_official>
      <last_name>Hongcheng Shi, Doctor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Nuclear Medicine, Zhongshan Hospital, Fudan University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hongcheng Shi, Doctor</last_name>
      <phone>+86 02164041990</phone>
      <phone_ext>2470</phone_ext>
      <email>shi.hongcheng@zs-hospital.sh.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yan Di</last_name>
      <phone>+86 051267229125</phone>
      <email>cm@smartnucl.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Zhongshan Hospital Affiliated to Fudan University</name>
        <address>
          <city>Shanghai</city>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Hongcheng Shi, Docter</last_name>
        <phone>+86 02164041990</phone>
        <phone_ext>2470</phone_ext>
        <email>shi.hongcheng@zs-hospital.sh.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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/NCT05989997
  org study id: SN-SNA002-2023-001
  nct id: NCT05989997
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The clinical trial was a single-center, dose-increasing, open trial.In this clinical trial,
        68Ga-NOTA-SNA002 was injected intravenously to observe its safety tolerance, radiation
        absorption dose, distribution characteristics, etc. in patients with solid tumors.
  The study consisted of four phases: screening period , baseline period , trial period and
        safety follow-up period .
  
        Screening period 2 weeks before the start of the trial, all eligible subjects were selected
        to participate in the clinical trial. The informed consent signed by the subjects is required
        before performing all the examinations in this clinical trial.
  
        Baseline period The admission criteria were checked again, and the subjects were enrolled on
        the same day after the check.
  
        Trial period Including drug administration, blood collection, image collection and
        pathological tissue collection.
  
        Safe follow-up period All adverse events and drug combinations are processed and recorded
        during this period.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Safety of administration(Vital signs)
  time frame: up to 7 days
  description: The safety of administration will be evaluated based on the assessments of blood pressure, heart rate, respiration and body temperature before and after administration(% of cases with abnormal findings relative to baseline).
  measure: Laboratory examination
  time frame: up to 7 days
  description: such as blood routine, blood biochemistry, urine routine, coagulation function, etc., to evaluate the changes of laboratory examination of subjects before and after administration
  measure: Incidence of adverse events
  time frame: through study completion, an average of 1 month
  description: The incident and severity of adverse events per CTCAE V5.0 criteria will be recorded following dose of 68Ga-NOTA-SNA002.
  measure: Biological distribution characteristics
  time frame: 60 minutes ~120 minutes after administration
  description: Description of biodistribution patterns of 68Ga-NOTA-SNA002 on PET
  measure: Anti-SNA002 anti-antibody
  time frame: up to 1 month
  description: By analyzing anti-SNA002 anti-drug antibody positive rate.
  measure: Changes in whole blood and serum radioactive dose
  time frame: 60 minutes after Blood sampling
  description: Measurement of 68Ga Radiation exposure in whole blood and serum after administration
  measure: Standardized uptake values based on whole-body PET imaging
  time frame: 1 month
  description: Analyzing whole body PET images，Define area of interest (ROI) and/or volume of Interest (VOI), calculate standardized uptake values (SUVmax, SUVmean, etc.)
  measure: Radiation absorbed dose of major organs
  time frame: 1 month
  description: Calculation of the radiation dose for each vital organ by means of radiation uptake values
  arm group label: dose escalation
  arm group type: Experimental
  description: 4 subgroups mass dose escalation.
  intervention type: Drug
  intervention name: 68Ga-NOTA-SNA002
  description: 68Ga-NOTA-SNA002 should be injected intravenously slowly for no less than 1min.
  arm group label: dose escalation
  other name: Positron Emission Tomography
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Hongcheng Shi, Doctor
  role: Principal Investigator
  affiliation: Department of Nuclear Medicine, Zhongshan Hospital, Fudan University
  last name: Hongcheng Shi, Doctor
  phone: +86 02164041990
  phone ext: 2470
  email: shi.hongcheng@zs-hospital.sh.cn
  last name: Yan Di
  phone: +86 051267229125
  email: cm@smartnucl.com
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  sharing ipd: No