<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/NCT04440059</url>
  </required_header>
  <id_info>
    <org_study_id>ICP-CL-00105</org_study_id>
    <nct_id>NCT04440059</nct_id>
  </id_info>
  <brief_title>A Study of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia</brief_title>
  <official_title>A Multicenter, Open Clinical Trial to Evaluate the Safety and Efficacy of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia (WM)</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>
      The phase II clinical study is to investigate the safety, tolerability, efficacy and&#xD;
      pharmacokinetics of ICP-022.&#xD;
&#xD;
      Safety, tolerability evaluation, and anti-tumor effects of ICP-022 in Chinese patients with&#xD;
      R/R WM will be evaluated in approximately 44 subjects. Pharmacokinetics of ICP-022 will be&#xD;
      evaluated in approximately 20 subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 10, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>Major response rate（MRR）</measure>
    <time_frame>Up to 3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The occurrence of adverse events and serious adverse events</measure>
    <time_frame>Cycle 1 (every 2 weeks), cycle 2-12 (every 4 weeks); After cycle 12 (every 12 weeks). Each cycle is 28 days.</time_frame>
    <description>The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 grading criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Major Mitigation (DOMR)</measure>
    <time_frame>Evaluate during the screening period, 1-6 treatment cycle every 2 cycles (8 weeks), 6th-27th cycles every 3 cycles, evaluating every 6 cycles after the 27th cycle. Each cycle is 28 days.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>Evaluate during the screening period, 1-6 treatment cycle every 2 cycles (8 weeks), 6th-27th cycles every 3 cycles, evaluating every 6 cycles after the 27th cycle. Each cycle is 28 days.</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Waldenstrom's Macroglobulinemia Recurrent</condition>
  <condition>Waldenstrom's Macroglobulinemia Refractory</condition>
  <arm_group>
    <arm_group_label>ICP-022</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will take ICP-022 150mg once daily (QD).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ICP-022</intervention_name>
    <description>ICP-022 at a dose of 150mg PO QD</description>
    <arm_group_label>ICP-022</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion criteria:&#xD;
&#xD;
          1. Clinical and histologically confirmed giant globulinemia Fahrenheit (WM Ii&#xD;
             International Working Group Standards, IWWM-2, 2003) (Owen et al., 2003)&#xD;
&#xD;
          2. At least one treatment indication is met (7th WM International Working Group&#xD;
             standards, IWWM-7) (Dimopoulos et al., 2014)&#xD;
&#xD;
          3. With the lowest serum IgM value &gt;2 times ULN as the efficacy evaluation index&#xD;
&#xD;
          4. ECOG physical strength score 0-2&#xD;
&#xD;
          5. Voluntary written informed consent prior to trial screening.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. Present or prior history of other malignant neoplasms, unless radical treatment has&#xD;
             been performed and there is no evidence of recurrence or metastasis in the last 5&#xD;
             years&#xD;
&#xD;
          2. Amyloidosis and central nervous system (CNS) involvement caused by WM&#xD;
&#xD;
          3. Demonstrate disease transformation&#xD;
&#xD;
          4. Patients who had received autologous stem cell transplantation within the previous 6&#xD;
             months&#xD;
&#xD;
          5. A history of organ transplantation or allogeneic bone marrow transplantation&#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>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital, Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China hospital of sichuan university</name>
      <address>
        <city>Sichuan</city>
        <state>Chengdu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Union Hospital affiliated to Fujian Medical University</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xiamen University</name>
      <address>
        <city>Xiamen</city>
        <state>Fujian</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Cancer Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Provincial Peoples's Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tongji Hospital affiliated to Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Soochow University</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shengjing Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruijin Hospital affiliated to Shanghai Jiao Tong University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of Hematology, Chinese Academy of Medical Sciences</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Union Hospital affiliated to Huazhong University of Science and Technology</name>
      <address>
        <city>Hubei</city>
        <state>Wuhan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhejiang University Medical College</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>May 18, 2023</last_update_submitted>
  <last_update_submitted_qc>May 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 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>Waldenstrom Macroglobulinemia</mesh_term>
    <mesh_term>Recurrence</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/NCT04440059
org study id: ICP-CL-00105
nct id: NCT04440059
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The phase II clinical study is to investigate the safety, tolerability, efficacy and
      pharmacokinetics of ICP-022.

      Safety, tolerability evaluation, and anti-tumor effects of ICP-022 in Chinese patients with
      R/R WM will be evaluated in approximately 44 subjects. Pharmacokinetics of ICP-022 will be
      evaluated in approximately 20 subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Major response rate（MRR）
time frame: Up to 3 years
measure: The occurrence of adverse events and serious adverse events
time frame: Cycle 1 (every 2 weeks), cycle 2-12 (every 4 weeks); After cycle 12 (every 12 weeks). Each cycle is 28 days.
description: The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 grading criteria
measure: Duration of Major Mitigation (DOMR)
time frame: Evaluate during the screening period, 1-6 treatment cycle every 2 cycles (8 weeks), 6th-27th cycles every 3 cycles, evaluating every 6 cycles after the 27th cycle. Each cycle is 28 days.
measure: Progression Free Survival (PFS)
time frame: Evaluate during the screening period, 1-6 treatment cycle every 2 cycles (8 weeks), 6th-27th cycles every 3 cycles, evaluating every 6 cycles after the 27th cycle. Each cycle is 28 days.
arm group label: ICP-022
arm group type: Experimental
description: Subjects will take ICP-022 150mg once daily (QD).
intervention type: Drug
intervention name: ICP-022
description: ICP-022 at a dose of 150mg PO QD
arm group label: ICP-022
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
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country: China
responsible party type: Sponsor
mesh term: Waldenstrom Macroglobulinemia
mesh term: Recurrence
sharing ipd: No