<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/NCT04438005</url>
  </required_header>
  <id_info>
    <org_study_id>ICP-CL-00108</org_study_id>
    <nct_id>NCT04438005</nct_id>
  </id_info>
  <brief_title>A Study of ICP-022 in Patients With R/R DLBCL</brief_title>
  <acronym>DLBCL</acronym>
  <official_title>A Multicenter, Open-Label Study to Investigate the Safety and Efficacy of ICP-022 in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma (DLBCL)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing InnoCare Pharma Tech Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing InnoCare Pharma Tech 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>
      It is a phase II, multicenter, open-label study is to evaluate the safety, efficacy and&#xD;
      pharmacokinetics of a novel BTK inhibitor, ICP-022, in approximately 85 subjects with R/R&#xD;
      DLBCL. There will be no control group in this study. Each subject will receive treatment&#xD;
      orally every day in 28-day cycles. Each cycle starts immediately after the previously&#xD;
      completed cycle without a break between cycles.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 7, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2023</primary_completion_date>
  <phase>Phase 2</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>Overall response rate（ORR）</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>The efficacy measured by overall response rate (ORR) according to the 2014 International Working Group NHL</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurrence of adverse events and serious adverse events</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 5.0 grading criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival（PFS）</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>The efficacy measured by progression free survival（PFS）</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response（DOR）</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">85</enrollment>
  <condition>Diffuse Large B Cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>ICP-022</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ICP-022</intervention_name>
    <description>ICP-022 is a white, round, uncoated tablet, 50 mg. It is administered orally at the dose of 150 mg/day from day 1 to day 28 of each cycle for up to a total of 6 cycles or until progression.</description>
    <arm_group_label>ICP-022</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion criteria：&#xD;
&#xD;
          1. Men and women between 18 and 75 years old,&#xD;
&#xD;
          2. Histologically confirmed diffuse large B-cell lymphoma（DLBCL）with MyD88 L265P and&#xD;
             CD79B positive, at least one measurable tumor of greater than 1.5 centimeter in long&#xD;
             axis by contrast-enhanced CT/MRI,&#xD;
&#xD;
          3. ECOG performance status of 0-2,&#xD;
&#xD;
          4. Voluntary written informed consent prior to trail screening.&#xD;
&#xD;
        Key Exclusion criteria:&#xD;
&#xD;
          1. History of other active malignancies, unless cured without evidence of relapse or&#xD;
             metastasis within 5 years of study entry&#xD;
&#xD;
          2. History of Richter's syndrome&#xD;
&#xD;
          3. Current or history of lymphoma involved central nervous system&#xD;
&#xD;
          4. Prior corticosteroids (at dosages equivalent to prednisone &gt; 20 mg/day) given with&#xD;
             anti-neoplastic intent within 7 days, prior chemotherapy, targeted therapy, radiation&#xD;
             therapy, or antibody based therapies or anti-cancer TCM within 4 weeks of the start of&#xD;
             study drug.&#xD;
&#xD;
          5. The investigator considers other conditions unsuitable for this study.&#xD;
&#xD;
        Note: Other protocol defined Inclusion/Exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jie Jin, PhD</last_name>
    <phone>13750853563</phone>
    <email>Jiej0503@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Affiliated Tumor Hospital of Harbin Medical University</name>
      <address>
        <city>Haerbin</city>
        <state>Heilongjiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qingyuan Zhang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei Xu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shengjing Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei Yang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Fourth Hospital of Hebei Medical University</name>
      <address>
        <city>Hebei</city>
        <state>Shijiazhuang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lihong Liu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hematology Hospital of Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences)</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei Liu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhejiang University Medical College</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jie Jin</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>August 23, 2022</last_update_submitted>
  <last_update_submitted_qc>August 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Relapsed/Refractory</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</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/NCT04438005
org study id: ICP-CL-00108
nct id: NCT04438005
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is a phase II, multicenter, open-label study is to evaluate the safety, efficacy and
      pharmacokinetics of a novel BTK inhibitor, ICP-022, in approximately 85 subjects with R/R
      DLBCL. There will be no control group in this study. Each subject will receive treatment
      orally every day in 28-day cycles. Each cycle starts immediately after the previously
      completed cycle without a break between cycles.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall response rate（ORR）
time frame: Up to 3 years
description: The efficacy measured by overall response rate (ORR) according to the 2014 International Working Group NHL
measure: Occurrence of adverse events and serious adverse events
time frame: Up to 3 years
description: The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 5.0 grading criteria
measure: Progression free survival（PFS）
time frame: Up to 3 years
description: The efficacy measured by progression free survival（PFS）
measure: Duration of response（DOR）
time frame: Up to 3 years
arm group label: ICP-022
arm group type: Experimental
intervention type: Drug
intervention name: ICP-022
description: ICP-022 is a white, round, uncoated tablet, 50 mg. It is administered orally at the dose of 150 mg/day from day 1 to day 28 of each cycle for up to a total of 6 cycles or until progression.
arm group label: ICP-022
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jie Jin, PhD
phone: 13750853563
email: Jiej0503@163.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, B-Cell
mesh term: Lymphoma, Large B-Cell, Diffuse
sharing ipd: No