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/NCT06006104</url>
    </required_header>
    <id_info>
      <org_study_id>HRS-4357-101</org_study_id>
      <nct_id>NCT06006104</nct_id>
    </id_info>
    <brief_title>Phase 1/2 Clinical Study of HRS-4357 in Patients With Advanced Prostate Cancer</brief_title>
    <official_title>A Phase I/II Clinical Study to Evaluate the Pharmacokinetics, Radiation Dosimetry, Safety and Preliminary Efficacy of HRS-4357 in Patients With PSMA Positive Advanced Prostate Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jiangsu HengRui Medicine Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Jiangsu HengRui Medicine 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>
        The study is being conducted to evaluate the the safety, pharmacokinetics, radiation&#xD;
        dosimetry, and preliminary efficacy of HRS-4357 injection in adult patients with advanced&#xD;
        prostate cancer.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
    <phase>Phase 1/Phase 2</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Prog Dose limiting toxicity (DLT)</measure>
      <time_frame>up to 9 months follow-up</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>recommended phase 2 dose (RP2D)</measure>
      <time_frame>up to 9 months follow-up</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>recommended dosing cycle.</measure>
      <time_frame>up to 9 months follow-up</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>PSA50 response rate</measure>
      <time_frame>up to 12 weeks follow-up</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Maximum plasma concentration (Cmax)</measure>
      <time_frame>up to 6 weeks follow-up</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>time to maximum plasma concentration (Tmax)</measure>
      <time_frame>up to 6 weeks follow-up</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>area under the plasma concentration-time curve (AUC)</measure>
      <time_frame>up to 6 weeks follow-up</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>clearance (Cl)</measure>
      <time_frame>up to 6 weeks follow-up</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>volume of distribution (Vz)</measure>
      <time_frame>up to 6 weeks follow-up</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>terminal half-life (t1/2)</measure>
      <time_frame>up to 6 weeks follow-up</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>cumulative urinary excretion of radioactive dose</measure>
      <time_frame>up to 6 weeks follow-up</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Absorbed dose and effective dose of radioactive internal irradiation of the whole body and major organs;</measure>
      <time_frame>up to 6 weeks follow-up</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PSA90 response rate</measure>
      <time_frame>up to 12 weeks follow-up]</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>time to PSA progression</measure>
      <time_frame>up to 9 months follow-up</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Response Rate (ORR)</measure>
      <time_frame>up to 20 months follow-up</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control Rate (DCR)</measure>
      <time_frame>up to 20 months follow-up</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DoR)</measure>
      <time_frame>up to 20 months follow-up</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Radiographic Progression-free Survival (rPFS)</measure>
      <time_frame>up to 9 months follow-up</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Survival (OS)</measure>
      <time_frame>up to 20 months follow-up</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence and severity of AEs and SAEs</measure>
      <time_frame>up to 20 months follow-up</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">49</enrollment>
    <condition>Advanced Prostate Cancer</condition>
    <arm_group>
      <arm_group_label>HRS-4357 injection</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>HRS-4357 injection</intervention_name>
      <description>HRS-4357 injection</description>
      <arm_group_label>HRS-4357 injection</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Voluntary participation in this clinical trial, understanding of the study procedures&#xD;
               and being able to sign the informed consent form in writing;&#xD;
  &#xD;
            2. Male, age ≥18 years;&#xD;
  &#xD;
            3. ECOG score 0 - 1;&#xD;
  &#xD;
            4. Histologically and/or cytologically confirmed adenocarcinoma of the prostate;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Spinal cord compression with clinical symptoms, or clinical symptoms and/or imaging&#xD;
               findings suggesting imminent spinal cord compression.&#xD;
  &#xD;
            2. Severe urinary incontinence, hydronephrosis, severe micturition dysfunction, etc.&#xD;
               Note: Subjects with bladder outflow obstruction or urinary incontinence that can be&#xD;
               controlled by the best available standard of care (including pads, drainage, etc.) are&#xD;
               eligible to participate in the study.&#xD;
  &#xD;
            3. Active syphilis infection.&#xD;
  &#xD;
            4. Known hypersensitivity to components of the study drug or its analogues.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Xueying Zheng</last_name>
      <phone>+0518-82342973</phone>
      <email>xueying.zheng.xz17@hengrui.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 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>Prostatic Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06006104
  org study id: HRS-4357-101
  nct id: NCT06006104
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The study is being conducted to evaluate the the safety, pharmacokinetics, radiation
        dosimetry, and preliminary efficacy of HRS-4357 injection in adult patients with advanced
        prostate cancer.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Prog Dose limiting toxicity (DLT)
  time frame: up to 9 months follow-up
  measure: recommended phase 2 dose (RP2D)
  time frame: up to 9 months follow-up
  measure: recommended dosing cycle.
  time frame: up to 9 months follow-up
  measure: PSA50 response rate
  time frame: up to 12 weeks follow-up
  measure: Maximum plasma concentration (Cmax)
  time frame: up to 6 weeks follow-up
  measure: time to maximum plasma concentration (Tmax)
  time frame: up to 6 weeks follow-up
  measure: area under the plasma concentration-time curve (AUC)
  time frame: up to 6 weeks follow-up
  measure: clearance (Cl)
  time frame: up to 6 weeks follow-up
  measure: volume of distribution (Vz)
  time frame: up to 6 weeks follow-up
  measure: terminal half-life (t1/2)
  time frame: up to 6 weeks follow-up
  measure: cumulative urinary excretion of radioactive dose
  time frame: up to 6 weeks follow-up
  measure: Absorbed dose and effective dose of radioactive internal irradiation of the whole body and major organs;
  time frame: up to 6 weeks follow-up
  measure: PSA90 response rate
  time frame: up to 12 weeks follow-up]
  measure: time to PSA progression
  time frame: up to 9 months follow-up
  measure: Overall Response Rate (ORR)
  time frame: up to 20 months follow-up
  measure: Disease control Rate (DCR)
  time frame: up to 20 months follow-up
  measure: Duration of Response (DoR)
  time frame: up to 20 months follow-up
  measure: Radiographic Progression-free Survival (rPFS)
  time frame: up to 9 months follow-up
  measure: Overall Survival (OS)
  time frame: up to 20 months follow-up
  measure: Incidence and severity of AEs and SAEs
  time frame: up to 20 months follow-up
  arm group label: HRS-4357 injection
  arm group type: Experimental
  intervention type: Drug
  intervention name: HRS-4357 injection
  description: HRS-4357 injection
  arm group label: HRS-4357 injection
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Xueying Zheng
  phone: +0518-82342973
  email: xueying.zheng.xz17@hengrui.com
  responsible party type: Sponsor
  mesh term: Prostatic Neoplasms
  sharing ipd: Undecided