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/NCT05983146</url>
    </required_header>
    <id_info>
      <org_study_id>HRS-7053-101</org_study_id>
      <nct_id>NCT05983146</nct_id>
    </id_info>
    <brief_title>Phase I Study of HRS-7053 Injection in the Treatment of Patients With Advanced Malignancies</brief_title>
    <official_title>A Phase I, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-7053 Injection in Patients With Advanced Malignancies</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>
        To evaluate the safety and tolerability of multiple administration of HRS-7053 in patients&#xD;
        with advanced malignancies Determine the maximum tolerated dose (MTD, if possible) and the&#xD;
        recommended dose for Phase II clinical studies (RP2D)&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2027</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence and severity of adverse events (AES)</measure>
      <time_frame>up to 3 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>MTD</measure>
      <time_frame>up to 3 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>RP2D</measure>
      <time_frame>up to 3 years</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time to maximum concentration (Tmax)</measure>
      <time_frame>up to 3 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum concentration (Cmax)</measure>
      <time_frame>up to 3 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the time curve from 0 to the last measurable concentration time point t (AUC0-t)</measure>
      <time_frame>up to 3 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective response rate （ORR）</measure>
      <time_frame>up to 3 years]</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate (DCR)</measure>
      <time_frame>up to 3 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival (PFS)</measure>
      <time_frame>up to 3 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response (DoR)</measure>
      <time_frame>up to 3 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>up to 3 years</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">186</enrollment>
    <condition>Advanced Malignant Cancer</condition>
    <arm_group>
      <arm_group_label>HRS-7053 Injection</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>HRS-7053 Injection</intervention_name>
      <description>HRS-7053 is administered by intravenous (IV) infusion once a week (QW) for one treatment cycle every 4 weeks</description>
      <arm_group_label>HRS-7053 Injection</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Voluntary participation in this study, signed informed consent, compliance is good,&#xD;
               can cooperate with follow-up&#xD;
  &#xD;
            2. Age ≥18 years, both male and female&#xD;
  &#xD;
            3. Histologically or cytologically confirmed patients with advanced hematologic&#xD;
               malignancies that have not responded to standard antitumor therapy and currently&#xD;
               indicate treatment&#xD;
  &#xD;
            4. Have measurable lesions&#xD;
  &#xD;
            5. ECOG PS score: 0-1&#xD;
  &#xD;
            6. Have a life expectancy of at least 3 months&#xD;
  &#xD;
            7. The functional level of the major organs must meet the requirements&#xD;
  &#xD;
            8. Fertile female patients must have a serum pregnancy test within 7 days before the&#xD;
               first medication and the result is negative; And must be non-lactating&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. The tumor infiltrates the central nervous system&#xD;
  &#xD;
            2. Received autologous stem cell transplantation within 12 weeks prior to administration&#xD;
               of the first study; Patients who have previously received allogeneic bone marrow&#xD;
               transplantation or solid organ transplantation; In the first study, Car T cell therapy&#xD;
               was administered within 12 weeks prior to drug administration&#xD;
  &#xD;
            3. Had major surgery or severe trauma 4 weeks prior to the first study; Or plan to&#xD;
               undergo major surgery during the study&#xD;
  &#xD;
            4. Received antitumor therapy within 2 weeks prior to administration of the first study&#xD;
               drug; Received Chinese herbal therapy within 2 weeks before the first dose of study&#xD;
               drug administration; Receiving steroid hormones for antitumor purposes within 7 days&#xD;
               before the first dose of the investigational drug administration&#xD;
  &#xD;
            5. Use of live attenuated vaccine within 28 days prior to signing the informed consent,&#xD;
               or expected to require live attenuated vaccine during the study period to 5 months&#xD;
               after the final dose&#xD;
  &#xD;
            6. Use of any potent drug that inhibits the liver drug metabolizing enzyme CYP3A for 14&#xD;
               days prior to first administration; Any potent drug that induces the liver drug&#xD;
               metabolizing enzyme CYP3A has been used for 28 days prior to first administration&#xD;
  &#xD;
            7. Previous treatment-induced adverse events did not recover to ≤CTCAE grade 1&#xD;
  &#xD;
            8. Participating in other clinical studies or signing informed consent less than 1 month&#xD;
               after the last medication in the previous clinical study&#xD;
  &#xD;
            9. The active phase of HBV or HCV infection is known&#xD;
  &#xD;
           10. A history of immunodeficiency, including HIV seropositive, or other acquired,&#xD;
               congenital immunodeficiency disorders&#xD;
  &#xD;
           11. Active infection or unexplained fever &amp;gt; 38.5 ° c&#xD;
  &#xD;
           12. A history of clinically severe cardiovascular disease; A history of myocarditis within&#xD;
               one year prior to drug administration was first studied&#xD;
  &#xD;
           13. The abnormality of electrocardiogram (ECG) was clinically significant&#xD;
  &#xD;
           14. In the first study, cerebrovascular accident, transient ischemic attack occurred&#xD;
               within 6 months prior to drug administration&#xD;
  &#xD;
           15. History of other malignancies within 5 years prior to drug administration was first&#xD;
               studied&#xD;
  &#xD;
           16. Known allergy to any component of the HRS-7053 product&#xD;
  &#xD;
           17. The presence of other serious physical or mental illnesses, abnormal laboratory tests,&#xD;
               and other factors that may increase the risk of participating in the study or&#xD;
               interfere with the study results; And any other conditions that the investigator deems&#xD;
               inappropriate for participation in this study&#xD;
  &#xD;
           18. Female subjects are pregnant or breastfeeding&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yanbo Liu</last_name>
      <phone>0518-82342973</phone>
      <email>yanbo.liu@hengrui.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jie Shen</last_name>
      <phone>0518-82342973</phone>
      <email>jie.shen@hengrui.com</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 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>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/NCT05983146
  org study id: HRS-7053-101
  nct id: NCT05983146
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate the safety and tolerability of multiple administration of HRS-7053 in patients
        with advanced malignancies Determine the maximum tolerated dose (MTD, if possible) and the
        recommended dose for Phase II clinical studies (RP2D)
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence and severity of adverse events (AES)
  time frame: up to 3 years
  measure: MTD
  time frame: up to 3 years
  measure: RP2D
  time frame: up to 3 years
  measure: Time to maximum concentration (Tmax)
  time frame: up to 3 years
  measure: Maximum concentration (Cmax)
  time frame: up to 3 years
  measure: Area under the time curve from 0 to the last measurable concentration time point t (AUC0-t)
  time frame: up to 3 years
  measure: Objective response rate （ORR）
  time frame: up to 3 years]
  measure: Disease control rate (DCR)
  time frame: up to 3 years
  measure: Progression-free survival (PFS)
  time frame: up to 3 years
  measure: Duration of response (DoR)
  time frame: up to 3 years
  measure: Overall survival (OS)
  time frame: up to 3 years
  arm group label: HRS-7053 Injection
  arm group type: Experimental
  intervention type: Drug
  intervention name: HRS-7053 Injection
  description: HRS-7053 is administered by intravenous (IV) infusion once a week (QW) for one treatment cycle every 4 weeks
  arm group label: HRS-7053 Injection
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yanbo Liu
  phone: 0518-82342973
  email: yanbo.liu@hengrui.com
  last name: Jie Shen
  phone: 0518-82342973
  email: jie.shen@hengrui.com
  responsible party type: Sponsor
  mesh term: Neoplasms
  sharing ipd: Undecided