<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/NCT04412577</url>
  </required_header>
  <id_info>
    <org_study_id>TQB3473-I-01</org_study_id>
    <nct_id>NCT04412577</nct_id>
  </id_info>
  <brief_title>A Study of TQB3473 Tablets in Subjects With Relapsed or Refractory Hematological Malignancies</brief_title>
  <official_title>A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3473 Tablets</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chia Tai Tianqing Pharmaceutical Group Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chia Tai Tianqing Pharmaceutical Group Co., Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study to evaluate the maximum tolerated dose (MTD), occurrence of all adverse&#xD;
      events (AE) and serious adverse events (SAE) , pharmacokinetic parameters and antitumor&#xD;
      effect of TQB3473 tablets in Chinese adult patients with Relapsed or refractory hematological&#xD;
      malignancies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 12, 2020</start_date>
  <completion_date type="Anticipated">June 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>Maximum tolerated dose (MTD)</measure>
    <time_frame>up to 31 days</time_frame>
    <description>MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tmax</measure>
    <time_frame>30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,12hour, 24hour, 48hour post-dose on day 1 and day 31; 30minutes pre-dose on day 1, day 4, day 11,day 18 ,day 25 and day 31.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax Cmax</measure>
    <time_frame>30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,12hour, 24hour, 48hour post-dose on day 1 and day 31; 30minutes pre-dose on day 1, day 4, day 11,day 18 ,day 25 and day 31.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-t</measure>
    <time_frame>30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,12hour, 24hour, 48hour post-dose on day 1 and day 31; 30minutes pre-dose on day 1, day 4, day 11,day 18 ,day 25 and day 31.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response rate (ORR)</measure>
    <time_frame>up to 96 weeks</time_frame>
    <description>Percentage of subjects achieving complete response (CR) and partial response (PR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>up to 96 weeks</time_frame>
    <description>PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>up to 96 weeks</time_frame>
    <description>DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">57</enrollment>
  <condition>Relapsed/Refractory Hematological Malignancies</condition>
  <arm_group>
    <arm_group_label>TQB3473 tablets</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TQB3473 tablets administered once daily in 28-day cycle .</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TQB3473</intervention_name>
    <description>TQB3473 tablets administered orally once. Then TQB3473 tablets administered orally, once daily in 28-day cycle after 3 days of first administration.</description>
    <arm_group_label>TQB3473 tablets</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -1.Understood and signed an informed consent form. 2. Relapsed or refractory malignant&#xD;
        hematological tumors. 3. Eastern Cooperative Oncology Group (ECOG) performance status score&#xD;
        of 0 to 1; Life expectancy ≥12 weeks.&#xD;
&#xD;
        4. Has at least one measurable lesion. 5. Adequate organ system function. 6. Patients need&#xD;
        to adopt effective methods of contraception.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Severe hypersensitivity to the drug or ingredients. 2. Has received chemotherapy,&#xD;
             radiotherapy, immunotherapy or any other anti-tumor therapy within 14 days before the&#xD;
             first dose.&#xD;
&#xD;
             3. Has received spleen tyrosine kinase (SYK) inhibitors. 4. Has to use ≥ 10 mg/day&#xD;
             glucocorticoid prednisone. 5. Has received BTK inhibitors and PI3K inhibitors before&#xD;
             the first dose. 6. Has received allogeneic hematopoietic stem cell transplantation. 7.&#xD;
             Has received autologous hematopoietic stem cell transplantation within 12 weeks before&#xD;
             the first dose.&#xD;
&#xD;
             8. Has any acute or chronic gastrointestinal diseases. 9. Has primary central nervous&#xD;
             system lymphoma, or brain metastases with clinical symptoms, spinal cord compression,&#xD;
             cancerous meningitis.&#xD;
&#xD;
             10. Intermediate-risk or high-risk myelodysplastic syndrome. 11. Pregnancy and&#xD;
             lactation women. 12. Has any serious and/or uncontrollable disease. 13. Has active&#xD;
             autoimmune disease and received immunosuppressive therapy. 14. Has a history of&#xD;
             neurological or mental disorders. 15. Has uncontrollable systemic bacterial, fungal or&#xD;
             viral active infections 16. The toxicity of previous antitumor treatment is not&#xD;
             recovered to ≤ grade 1. 17. Has other malignancies. 18. Has received surgery within 4&#xD;
             weeks before the first administration. 19. Has participated in any other clinical&#xD;
             trials. 20. According to the judgement of the investigators, there are other factors&#xD;
             that may lead to the termination of the study.&#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>Peng Liu, Doctor</last_name>
    <phone>021-60267405</phone>
    <email>Liu.peng@zs-hospital.sh.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Henan Cancer Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yongping Song, Doctor</last_name>
      <email>songyongping@medmail.com.cn</email>
    </contact>
    <investigator>
      <last_name>Yongping Song, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peng Liu, Doctor</last_name>
      <phone>021-60267405</phone>
      <email>Liu.peng@zs-hospital.sh.cn</email>
    </contact>
    <investigator>
      <last_name>Peng Liu, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>March 29, 2021</last_update_submitted>
  <last_update_submitted_qc>March 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2021</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>Neoplasms</mesh_term>
    <mesh_term>Hematologic Neoplasms</mesh_term>
  </condition_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/NCT04412577
org study id: TQB3473-I-01
nct id: NCT04412577
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a study to evaluate the maximum tolerated dose (MTD), occurrence of all adverse
      events (AE) and serious adverse events (SAE) , pharmacokinetic parameters and antitumor
      effect of TQB3473 tablets in Chinese adult patients with Relapsed or refractory hematological
      malignancies.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum tolerated dose (MTD)
time frame: up to 31 days
description: MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.
measure: Tmax
time frame: 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,12hour, 24hour, 48hour post-dose on day 1 and day 31; 30minutes pre-dose on day 1, day 4, day 11,day 18 ,day 25 and day 31.
measure: Cmax Cmax
time frame: 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,12hour, 24hour, 48hour post-dose on day 1 and day 31; 30minutes pre-dose on day 1, day 4, day 11,day 18 ,day 25 and day 31.
measure: AUC0-t
time frame: 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,12hour, 24hour, 48hour post-dose on day 1 and day 31; 30minutes pre-dose on day 1, day 4, day 11,day 18 ,day 25 and day 31.
measure: Overall response rate (ORR)
time frame: up to 96 weeks
description: Percentage of subjects achieving complete response (CR) and partial response (PR).
measure: Progression-free survival (PFS)
time frame: up to 96 weeks
description: PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.
measure: Duration of Response (DOR)
time frame: up to 96 weeks
description: DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
arm group label: TQB3473 tablets
arm group type: Experimental
description: TQB3473 tablets administered once daily in 28-day cycle .
intervention type: Drug
intervention name: TQB3473
description: TQB3473 tablets administered orally once. Then TQB3473 tablets administered orally, once daily in 28-day cycle after 3 days of first administration.
arm group label: TQB3473 tablets
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Peng Liu, Doctor
phone: 021-60267405
email: Liu.peng@zs-hospital.sh.cn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Hematologic Neoplasms