<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/NCT04485052</url>
  </required_header>
  <id_info>
    <org_study_id>CIBI188B201</org_study_id>
    <nct_id>NCT04485052</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Evaluation of IBI188 in Combination With Demethylating Agents in Treatment of Patients With Acute Myeloid Leukemia</brief_title>
  <official_title>A Phase Ib Study Evaluating the Safety and Efficacy of IBI188 in Combination With Demethylating Agents in Subjects With Acute Myeloid Leukemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Innovent Biologics (Suzhou) Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Innovent Biologics (Suzhou) 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>
      The study is to evaluate safety, tolerability and composite CR of IBI188 plus Demethylating&#xD;
      Agents in acute myeloid leukemia&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Pause for changes in development strategies&#xD;
  </why_stopped>
  <start_date type="Actual">September 25, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2023</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>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite complete rate</measure>
    <time_frame>24 weeks</time_frame>
    <description>Composite CR including complete remission rate and morphologic complete remission with incomplete blood count recovery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cytogenetic CR</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">222</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <arm_group>
    <arm_group_label>IBI188+azacitidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1L unfit AML receive IBI188 every week by intravenous(IV) and azacitidine daily in Day 1-7 of each four weeks(Q4W) by subcutaneous(IH)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IBI188+decitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>R/R AML receive IBI188 every week by intravenous(IV) and decitabine daily in Day 1-10 of each four weeks(Q4W) by subcutaneous(IH)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IBI188</intervention_name>
    <description>anti-CD47 Monoclonal antibody</description>
    <arm_group_label>IBI188+azacitidine</arm_group_label>
    <arm_group_label>IBI188+decitabine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azacitidine</intervention_name>
    <description>Demethylation drugs</description>
    <arm_group_label>IBI188+azacitidine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Decitabine</intervention_name>
    <description>Demethylation drugs</description>
    <arm_group_label>IBI188+decitabine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. AML patients diagnosed according to WHO AML diagnostic criteria in 2016 (except&#xD;
             M3-type and BCR-ABL positive AML).&#xD;
&#xD;
          2. Relapsed// refractory AML( ≥18 ys) or newly diagnosed elderly AML unfit for intensive&#xD;
             chemotherapy( ≥60 ys).&#xD;
&#xD;
          3. Age ≥18 years old, gender not limited.&#xD;
&#xD;
          4. ECOG score of 0-2.&#xD;
&#xD;
          5. Adequate organ function.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Acute promyelocytic leukemia, myeloid sarcoma, acute heterozygous leukemia,&#xD;
             CMML(accelerated phase and blast phase).&#xD;
&#xD;
          2. A history of myeloproliferative diseases (including myelofibrosis, primary&#xD;
             thrombocytosis, and true red) Cytosis, chronic myelocytic leukemia) or acute myeloid&#xD;
             white blood with BCR-ABL1 translocation Patients.&#xD;
&#xD;
          3. Major surgery and vaccine treatment within 4 weeks.&#xD;
&#xD;
          4. Uncontrolled concurrent diseases.&#xD;
&#xD;
          5. Pregnant or breastfeeding female subjects.&#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>The First Affiliated Hospital of Soochow University</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <zip>215006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>February 14, 2023</last_update_submitted>
  <last_update_submitted_qc>February 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 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</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azacitidine</mesh_term>
    <mesh_term>Decitabine</mesh_term>
  </intervention_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/NCT04485052
org study id: CIBI188B201
nct id: NCT04485052
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is to evaluate safety, tolerability and composite CR of IBI188 plus Demethylating
      Agents in acute myeloid leukemia
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Composite complete rate
time frame: 24 weeks
description: Composite CR including complete remission rate and morphologic complete remission with incomplete blood count recovery
measure: Cytogenetic CR
time frame: 24 weeks
arm group label: IBI188+azacitidine
arm group type: Experimental
description: 1L unfit AML receive IBI188 every week by intravenous(IV) and azacitidine daily in Day 1-7 of each four weeks(Q4W) by subcutaneous(IH)
arm group label: IBI188+decitabine
arm group type: Experimental
description: R/R AML receive IBI188 every week by intravenous(IV) and decitabine daily in Day 1-10 of each four weeks(Q4W) by subcutaneous(IH)
intervention type: Drug
intervention name: IBI188
description: anti-CD47 Monoclonal antibody
arm group label: IBI188+azacitidine
arm group label: IBI188+decitabine
intervention type: Drug
intervention name: Azacitidine
description: Demethylation drugs
arm group label: IBI188+azacitidine
intervention type: Drug
intervention name: Decitabine
description: Demethylation drugs
arm group label: IBI188+decitabine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Azacitidine
mesh term: Decitabine