<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/NCT04414150</url>
  </required_header>
  <id_info>
    <org_study_id>SHR-1802-I-101</org_study_id>
    <nct_id>NCT04414150</nct_id>
  </id_info>
  <brief_title>A Trial of SHR-1802 in Patients With Failure of Standard Treatment for Advanced Malignant Tumours</brief_title>
  <official_title>Tolerability, Safety and Pharmacokinetic Characteristics of SHR-1802 in Patients With Advanced Malignancy: a Phase I Clinical Study</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>
    <has_dmc>No</has_dmc>
    <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 the first study to test SHR-1802 in humans. The primary purpose of this study is to&#xD;
      see if SHR-1802 is safe and tolerable for patients with locally advanced/unresectable or&#xD;
      metastatic malignancies that are refractory to available therapy or for which no standard&#xD;
      therapy is available.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 17, 2020</start_date>
  <completion_date type="Actual">March 15, 2022</completion_date>
  <primary_completion_date type="Actual">January 13, 2022</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>Dose limiting toxicity</measure>
    <time_frame>Days 1-21</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with adverse events</measure>
    <time_frame>from the first drug administration to within 90 days for the last SHR-1802 dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of dose suspension, dose reduction and dose discontinuation caused by investigational drug related adverse events</measure>
    <time_frame>At pre-defined intervals from initial dose up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ORR</measure>
    <time_frame>At pre-defined intervals from initial dose up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DOR</measure>
    <time_frame>At pre-defined intervals from initial dose up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DCR</measure>
    <time_frame>At pre-defined intervals from initial dose up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFS</measure>
    <time_frame>At pre-defined intervals from initial dose up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Concentration (Cmax) of SHR-1802</measure>
    <time_frame>At pre-defined intervals from initial dose through final study visit (up to 24 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of Maximum Concentration (Tmax) of SHR-1802</measure>
    <time_frame>At pre-defined intervals from initial dose through final study visit (up to 24 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve (AUC) of SHR-1802</measure>
    <time_frame>At pre-defined intervals from initial dose through final study visit (up to 24 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal Half-Life (T1/2) of SHR-1802</measure>
    <time_frame>At pre-defined intervals from initial dose through final study visit (up to 24 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clearance (CL) of SHR-1802</measure>
    <time_frame>At pre-defined intervals from initial dose through final study visit (up to 24 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of Distribution at Steady State (Vss) of SHR-1802</measure>
    <time_frame>At pre-defined intervals from initial dose through final study visit (up to 24 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the immunogenicity of SHR-1802</measure>
    <time_frame>At pre-defined intervals from initial dose through final study visit (up to 24 months)</time_frame>
    <description>Serum sampling to assess the potential for anti-drug antibody (ADA) formation.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Malignant Tumours</condition>
  <arm_group>
    <arm_group_label>SHR-1802</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SHR-1802</intervention_name>
    <description>This study will evaluate the preliminary safety, tolerability, pharmacokinetic characteristics and initial efficacy of SHR-1802 The goal is to establish the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of sequential escalating doses of SHR-1802 when administered to patients with locally advanced/ unresectable or metastatic malignant tumours that are refractory to available therapy or for which no standard therapy is available.</description>
    <arm_group_label>SHR-1802</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Voluntary participation and written informed consent;&#xD;
&#xD;
          2. Aged 18-75 years (inclusive), males and females;&#xD;
&#xD;
          3. Patient must have histologically or clinically confirmed advanced and/or metastatic&#xD;
             malignancies for which failure of standard treatment or lack of effective standard&#xD;
             treatment;&#xD;
&#xD;
          4. At least one measurable lesion according to RECIST v1.1;&#xD;
&#xD;
          5. ECOG score of 0-1;&#xD;
&#xD;
          6. Expected survival ≥ 12 weeks;&#xD;
&#xD;
          7. Adequate bone marrow reserve and organ function were confirmed by baseline examination&#xD;
&#xD;
          8. For female patients of childbearing potential or male patients with partners of&#xD;
             childbearing potential who are not sterilized by surgical operations, they are&#xD;
             required to use a medically approved contraceptive measure during the study treatment&#xD;
             period and within 3 months after the end of the study treatment; For female patients&#xD;
             of childbearing potential who are not sterilized by surgical operations, they must&#xD;
             have a negative serum HCG test result within 72 h prior to study enrollment; and they&#xD;
             must not be in the lactation period;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The presence of any active, known, or suspected autoimmune disease. Type 1 diabetes,&#xD;
             which was admitted to receive stable dose of insulin, hypothyroidism, which required&#xD;
             only hormone replacement therapy, skin disease with no need to systemic treatment and&#xD;
             no acute exacerbation within 1 year before the screening period;&#xD;
&#xD;
          2. Subjects who had received systemic treatment with corticosteroids or other&#xD;
             immunosuppressive agents within 28 days prior to initial administration.&#xD;
&#xD;
          3. Known and untreated central nervous system (CNS) or leptomeningeal metastases;&#xD;
&#xD;
          4. Uncontrolled pleural effusion,or ascites requiring recurrent drainage procedures;&#xD;
&#xD;
          5. Uncontrolled cardiac diseases or symptoms;&#xD;
&#xD;
          6. Known hereditary or acquired bleeding and thrombotic tendencies;&#xD;
&#xD;
          7. Patients who have previously received chemotherapy, radiotherapy or surgery which&#xD;
             ended within 4 weeks prior to the start of this study; oral molecular targeted therapy&#xD;
             with &lt; 5 drug half-lives from the first study dose; or patients with AEs caused by&#xD;
             previous treatment (except for alopecia) that have not returned to CTCAE Grade ≤ 1;&#xD;
&#xD;
          8. Known active infection,;&#xD;
&#xD;
          9. Congenital and acquired immune deficiency;&#xD;
&#xD;
         10. HBsAg-positive and HBV DNA &gt; 2000 IU/mL(or 104 copies/mL); HCV RNA copies &gt; ULN;&#xD;
&#xD;
         11. Patients with other potential factors that may affect the study results or result in&#xD;
             the premature discontinuation as determined by the investigator, such as alcoholism,&#xD;
             drug abuse, other serious diseases (including mental illness) requiring concomitant&#xD;
             treatment, serious laboratory abnormalities, or family or social factors that could&#xD;
             affect the safety of the patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tianjin Medical University Cancer Institute and Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2022</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>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04414150
org study id: SHR-1802-I-101
nct id: NCT04414150
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is the first study to test SHR-1802 in humans. The primary purpose of this study is to
      see if SHR-1802 is safe and tolerable for patients with locally advanced/unresectable or
      metastatic malignancies that are refractory to available therapy or for which no standard
      therapy is available.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Dose limiting toxicity
time frame: Days 1-21
measure: Percentage of patients with adverse events
time frame: from the first drug administration to within 90 days for the last SHR-1802 dose
measure: Rates of dose suspension, dose reduction and dose discontinuation caused by investigational drug related adverse events
time frame: At pre-defined intervals from initial dose up to 24 months
measure: ORR
time frame: At pre-defined intervals from initial dose up to 24 months
measure: DOR
time frame: At pre-defined intervals from initial dose up to 24 months
measure: DCR
time frame: At pre-defined intervals from initial dose up to 24 months
measure: PFS
time frame: At pre-defined intervals from initial dose up to 24 months
measure: Maximum Concentration (Cmax) of SHR-1802
time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
measure: Time of Maximum Concentration (Tmax) of SHR-1802
time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
measure: Area Under the Curve (AUC) of SHR-1802
time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
measure: Terminal Half-Life (T1/2) of SHR-1802
time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
measure: Clearance (CL) of SHR-1802
time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
measure: Volume of Distribution at Steady State (Vss) of SHR-1802
time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
measure: Evaluation of the immunogenicity of SHR-1802
time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
description: Serum sampling to assess the potential for anti-drug antibody (ADA) formation.
arm group label: SHR-1802
arm group type: Experimental
intervention type: Drug
intervention name: SHR-1802
description: This study will evaluate the preliminary safety, tolerability, pharmacokinetic characteristics and initial efficacy of SHR-1802 The goal is to establish the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of sequential escalating doses of SHR-1802 when administered to patients with locally advanced/ unresectable or metastatic malignant tumours that are refractory to available therapy or for which no standard therapy is available.
arm group label: SHR-1802
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Neoplasms