<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/NCT04443751</url>
  </required_header>
  <id_info>
    <org_study_id>SHR-1702-I-102</org_study_id>
    <nct_id>NCT04443751</nct_id>
  </id_info>
  <brief_title>A Safety and Efficacy Study of SHR-1702 Monotherapy in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)</brief_title>
  <official_title>A Phase I, Multicenter, Open-label Study of SHR-1702 in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome</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 study will assess the safety and preliminary efficacy of escalating doses of SHR-1702&#xD;
      monotherapy in relapsed/refractory AML and intermediate-high risk MDS&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 10, 2020</start_date>
  <completion_date type="Actual">February 28, 2023</completion_date>
  <primary_completion_date type="Actual">February 28, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of SHR-1702 monotherapy in patients with AML or MDS.</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with the type, frequency, and severity of adverse events (AEs) as a measure of safety and tolerability of SHR-1702 monotherapy in AML and MDS patients</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Concentration (Cmax) of SHR-1702 monotherapy in patients with AML or MDS</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum Concentration (Cmax) of SHR-1702 monotherapy in patients with AML or MDS</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity as assessed by the presence of anti-drug antibodies</measure>
    <time_frame>2 years</time_frame>
    <description>Anti SHR-1702 antibodies will be tested frequently</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic profile as assessed by receptor occupancy</measure>
    <time_frame>2 years</time_frame>
    <description>SHR-1702 receptor occupation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate（ORR）for SHR-1702 in AML based on IWG2003 or high risk MDS based on IWG2006</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best of Response（BOR）for SHR-1702 in AML or high risk MDS</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival（PFS) for SHR-1702 in AML or high risk MDS</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival（OS) for SHR-1702 in AML or high risk MDS</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>AML</condition>
  <condition>MDS</condition>
  <arm_group>
    <arm_group_label>SHR-1702 monotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SHR-1702 monotherapy, given intravenously (IV); dose escalation and dose expansion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SHR-1702</intervention_name>
    <description>SHR-1702 monotherapy, administered IV</description>
    <arm_group_label>SHR-1702 monotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female.&#xD;
&#xD;
          2. ≥18 years of age.&#xD;
&#xD;
          3. Refractory/Relapsed AML, or failed to achieve complete remission after 2 cycles of&#xD;
             induction therapy.&#xD;
&#xD;
          4. Intermediate, High and very high risk MDS according to the revised International&#xD;
             Prognostic Scoring System (IPSS-R) who have failed prior therapies, such as&#xD;
             azacitidine and decitabine (Scoring≥3.5).&#xD;
&#xD;
          5. Life expectancy≥12 months.&#xD;
&#xD;
          6. With Adequate hematologic and organ function&#xD;
&#xD;
          7. Signed inform consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. With a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced&#xD;
             pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening&#xD;
             chest CT scan.&#xD;
&#xD;
          2. With significant cardiovascular disease.&#xD;
&#xD;
          3. With a history of autoimmune disease.&#xD;
&#xD;
          4. Subjects with a condition requiring systemic treatment with either corticosteroids&#xD;
             (&gt;10 mg daily prednisone equivalent) or other immunosuppressive medications within 14&#xD;
             days of first administration of study treatment. Inhaled or topical steroids, and&#xD;
             adrenal replacement steroid are permitted in the absence of active autoimmune disease.&#xD;
&#xD;
          5. Positive test result for human immunodeficiency virus (HIV); Active hepatitis B or&#xD;
             hepatitis C.&#xD;
&#xD;
          6. Active or untreated central nervous system (CNS) metastases.&#xD;
&#xD;
          7. Active infection within 2 weeks.&#xD;
&#xD;
          8. Know to be allergic to the ingredients of SHR-1702 injection.&#xD;
&#xD;
          9. Prior allogeneic bone marrow transplantation or solid organ transplant&#xD;
&#xD;
         10. With a history or current evidence of any condition, therapy, or laboratory&#xD;
             abnormality that might confound the results of the study, interfere with the subject's&#xD;
             participation for the full duration of the study, or is not in the best interest of&#xD;
             the subject to participate, in the opinion of the treating investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Blood disease hospital of Chinese Academy of Medical Sciences</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>August 23, 2023</last_update_submitted>
  <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 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>Leukemia, Myeloid, Acute</mesh_term>
    <mesh_term>Preleukemia</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04443751
org study id: SHR-1702-I-102
nct id: NCT04443751
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will assess the safety and preliminary efficacy of escalating doses of SHR-1702
      monotherapy in relapsed/refractory AML and intermediate-high risk MDS
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of SHR-1702 monotherapy in patients with AML or MDS.
time frame: 6 months
measure: Number of participants with the type, frequency, and severity of adverse events (AEs) as a measure of safety and tolerability of SHR-1702 monotherapy in AML and MDS patients
time frame: 2 years
measure: Maximum Concentration (Cmax) of SHR-1702 monotherapy in patients with AML or MDS
time frame: 2 years
measure: Minimum Concentration (Cmax) of SHR-1702 monotherapy in patients with AML or MDS
time frame: 2 years
measure: Immunogenicity as assessed by the presence of anti-drug antibodies
time frame: 2 years
description: Anti SHR-1702 antibodies will be tested frequently
measure: Pharmacodynamic profile as assessed by receptor occupancy
time frame: 2 years
description: SHR-1702 receptor occupation
measure: Objective response rate（ORR）for SHR-1702 in AML based on IWG2003 or high risk MDS based on IWG2006
time frame: 2 years
measure: Best of Response（BOR）for SHR-1702 in AML or high risk MDS
time frame: 2 years
measure: Progression-Free Survival（PFS) for SHR-1702 in AML or high risk MDS
time frame: 2 years
measure: Overall Survival（OS) for SHR-1702 in AML or high risk MDS
time frame: 2 years
arm group label: SHR-1702 monotherapy
arm group type: Experimental
description: SHR-1702 monotherapy, given intravenously (IV); dose escalation and dose expansion.
intervention type: Drug
intervention name: SHR-1702
description: SHR-1702 monotherapy, administered IV
arm group label: SHR-1702 monotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Leukemia, Myeloid, Acute
mesh term: Preleukemia
mesh term: Myelodysplastic Syndromes
sharing ipd: No