<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/NCT04485065</url>
  </required_header>
  <id_info>
    <org_study_id>CIBI188C301</org_study_id>
    <nct_id>NCT04485065</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of IBI188 With Azacitidine in Subjects With Newly Diagnosed Higher Risk MDS</brief_title>
  <official_title>A Phase Ib Study Evaluating the Safety and Efficacy of IBI188 in Combination With Azacitidine in Subjects With Newly Diagnosed Higher Risk Myelodysplastic Syndrome</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 and efficacy of IBI188 in combination with azacitidine (AZA)&#xD;
      as a first-line treatment in subjects with newly diagnosed higher risk myelodysplastic&#xD;
      syndrome&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Suspended for changes in development strategy&#xD;
  </why_stopped>
  <start_date type="Actual">September 30, 2020</start_date>
  <completion_date type="Anticipated">August 20, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 30, 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>Safety and tolerability</measure>
    <time_frame>24 months</time_frame>
    <description>To evaluate the safety and tolerability of IBI188 combined with Azacitidine (AZA) in first-line treatment of Myelodysplastic syndrome (MDS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complete response rate (CR) and duration of complete response (DoCR)</measure>
    <time_frame>24 months</time_frame>
    <description>Complete response rate (CR) and duration of complete response (DoCR) in high-risk MDS subjects with IBI188 combined with AZA as first-line therapy evaluated by the central laboratory.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complete response rate (CR) and duration of complete response (DoCR)</measure>
    <time_frame>24 months</time_frame>
    <description>Complete response rate (CR) and duration of complete response (DoCR) in high-risk MDS subjects with IBI188 combined with AZA as first-line therapy evaluated by the investigators;</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Myelodysplastic Syndromes</condition>
  <arm_group>
    <arm_group_label>IBI188+azacitidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IBI188+azacitidine</intervention_name>
    <description>Escalating and maintenance dose of IBI188 will be administered 30mg/kg, IV(intravenous infusion),Q4W&#xD;
Drug:Azacitidine Azacitidine will be administered daily for 7 days, IH, Q4W</description>
    <arm_group_label>IBI188+azacitidine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. MDS subjects with higher risk;&#xD;
&#xD;
          2. Age ≥ 18 years old;&#xD;
&#xD;
          3. Eastern Cooperative Oncology Group score of 0~1;&#xD;
&#xD;
          4. Not suitable for or refuse to receive HSCT;&#xD;
&#xD;
          5. Newly diagnosed MDS subjects;&#xD;
&#xD;
          6. Adequate organ function;&#xD;
&#xD;
          7. Subjects should take effective contraceptive measures&#xD;
&#xD;
          8. Must sign the Informed Consent Form (ICF), and be able to follow all study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject who has transformed from MDS to AML.&#xD;
&#xD;
          2. Therapy-related MDS (t-MDS), myeloproliferative neoplasm (MPN)- transformed&#xD;
             MDS,MDS/MPN.&#xD;
&#xD;
          3. MDS subjects with lower risk.&#xD;
&#xD;
          4. Subjects who have received chemotherapy.&#xD;
&#xD;
          5. Prior exposure to any anti-CD47 or anti-SIRPα agents.&#xD;
&#xD;
          6. Subjects participating in another interventional clinical study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Blood Diseases Hospital Chinese Academy Of Medical Science</name>
      <address>
        <city>Tianjin</city>
        <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>
  <keyword>MDS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Preleukemia</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azacitidine</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/NCT04485065
org study id: CIBI188C301
nct id: NCT04485065
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is to evaluate safety and efficacy of IBI188 in combination with azacitidine (AZA)
      as a first-line treatment in subjects with newly diagnosed higher risk myelodysplastic
      syndrome
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety and tolerability
time frame: 24 months
description: To evaluate the safety and tolerability of IBI188 combined with Azacitidine (AZA) in first-line treatment of Myelodysplastic syndrome (MDS)
measure: Complete response rate (CR) and duration of complete response (DoCR)
time frame: 24 months
description: Complete response rate (CR) and duration of complete response (DoCR) in high-risk MDS subjects with IBI188 combined with AZA as first-line therapy evaluated by the central laboratory.
measure: Complete response rate (CR) and duration of complete response (DoCR)
time frame: 24 months
description: Complete response rate (CR) and duration of complete response (DoCR) in high-risk MDS subjects with IBI188 combined with AZA as first-line therapy evaluated by the investigators;
arm group label: IBI188+azacitidine
arm group type: Experimental
intervention type: Drug
intervention name: IBI188+azacitidine
description: Escalating and maintenance dose of IBI188 will be administered 30mg/kg, IV(intravenous infusion),Q4W
Drug:Azacitidine Azacitidine will be administered daily for 7 days, IH, Q4W
arm group label: IBI188+azacitidine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Preleukemia
mesh term: Myelodysplastic Syndromes
mesh term: Syndrome
mesh term: Azacitidine