<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/NCT03754244</url>
  </required_header>
  <id_info>
    <org_study_id>TQB3456-I-01</org_study_id>
    <nct_id>NCT03754244</nct_id>
  </id_info>
  <brief_title>A Phase I Study of TQ-B3456 on Tolerance and Pharmacokinetics</brief_title>
  <official_title>A Phase I Study of TQ-B3456 on Tolerance and Pharmacokinetics</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>
      To study the pharmacokinetic characteristics of TQ-B3456 in the human body, recommend a&#xD;
      reasonable regimen for subsequent research.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The enrolment task cannot be gotten within the planned time.It mainly includes patients with&#xD;
    non-small cell lung cancer failed in standard treatment,with a short survival period.It is hard&#xD;
    to obtain observational endpoints for bone-related events.&#xD;
  </why_stopped>
  <start_date type="Actual">September 24, 2020</start_date>
  <completion_date type="Actual">February 28, 2022</completion_date>
  <primary_completion_date type="Actual">February 28, 2022</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>Dose-Limiting Toxicities（DLT）</measure>
    <time_frame>Baseline up to 28 days</time_frame>
    <description>an adverse event cccurring after initiation of TQ-B3456 that met any following criteria：&#xD;
&gt;=Grade 3 of non-hematology toxicity&#xD;
Grade 4 hematology toxicity</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>TQB3456</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>p.o. qd</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TQB3456</intervention_name>
    <description>Observe the safety and pk when the subjects take TQB3456 p.o. qd</description>
    <arm_group_label>TQB3456</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - progressive or metastatic non-small cell lung cancer that diagnosed Pathologically or&#xD;
        cytologically diagnosed patients who have received EGFR tyrosine kinase inhibitor&#xD;
        monotherapy (e.g., gefetinib, erlotinib, ecotinib, afatinib) for disease progression EGFR&#xD;
        T790M mutation was confirmed ECOG PS≤1 Adequate blood cell counts, kidney function and&#xD;
        liver function Patients should participate in the study voluntarily and sign informed&#xD;
        consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with non-small-cell lung cancer who have received osimertinib or other raw&#xD;
        materials or preparations for EGFRT790M mutant drugs Hypertension (systolic BP ≥140 mmHg,&#xD;
        diastolic BP ≥90 mmHg) still uncontrollable by one medication; Hepatitis B virus patients&#xD;
        with active replication (DNA&gt; 500 cps / mL), hepatitis C; Patients with immunodeficiency,&#xD;
        including HIV positive or other acquired, congenital immunodeficiency disease, or organ&#xD;
        transplant history&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>No. 241 Huaihai West Road, Xuhui District, Shanghai</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>March 29, 2022</last_update_submitted>
  <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2022</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>Carcinoma, Non-Small-Cell Lung</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/NCT03754244
org study id: TQB3456-I-01
nct id: NCT03754244
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To study the pharmacokinetic characteristics of TQ-B3456 in the human body, recommend a
      reasonable regimen for subsequent research.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Dose-Limiting Toxicities（DLT）
time frame: Baseline up to 28 days
description: an adverse event cccurring after initiation of TQ-B3456 that met any following criteria：
>=Grade 3 of non-hematology toxicity
Grade 4 hematology toxicity
arm group label: TQB3456
arm group type: Experimental
description: p.o. qd
intervention type: Drug
intervention name: TQB3456
description: Observe the safety and pk when the subjects take TQB3456 p.o. qd
arm group label: TQB3456
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: No