xml: <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/NCT05997342</url>
    </required_header>
    <id_info>
      <org_study_id>TQB3912-I-01</org_study_id>
      <nct_id>NCT05997342</nct_id>
    </id_info>
    <brief_title>A Clinical Study of TQB3912 Tablets in Patients With Advanced Malignant Tumor</brief_title>
    <official_title>A Phase I Clinical Trial to Evaluate the Safety and Tolerability of TQB3912 Tablets in Subjects With Advanced Malignancies</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 (AEs) and serious adverse events (SAEs), pharmacokinetic parameters and antitumor&#xD;
        effect of TQB3912 tablets in Chinese adult patients with advanced malignant neoplasm. The&#xD;
        study was divided into phase Ia and phase Ib, Phase Ia: Dose escalation period, to evaluate&#xD;
        the safety and tolerability of TQB3912 tablets, determine MTD; Phase Ib: Effectiveness&#xD;
        exploration period, to expand the safe and effective dose group, and to recommend appropriate&#xD;
        dosage and method for subsequent clinical research.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2025</completion_date>
    <primary_completion_date type="Anticipated">March 2024</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>During the first 28 days.</time_frame>
      <description>Subjects within 28 days after treatment appear the following toxicity reaction relate to the drug: grade III or above of non-hematological toxicity, grade III hematological toxicity, Neutropenia associated with fever.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum tolerated dose (MTD)</measure>
      <time_frame>During the first 29 days.</time_frame>
      <description>MTD is defined as the highest dosing schedule cohort level at which no more than 1 of 6 patients experience a Dose Limiting Toxicity (DLT).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Overall response rate (ORR)</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>From the first drug treatment to the last drug treatment.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of adverse events (AEs)</measure>
      <time_frame>From the time of informed consent signed to 90 days after the last dose</time_frame>
      <description>Number of patients with adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of serious adverse events (SAEs)</measure>
      <time_frame>From the time of informed consent signed to 90 days after the last dose</time_frame>
      <description>Number of patients with serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate (DCR)</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>The proportion of subjects with Complete response (CR), Partial response (PR), or Stable Disease (SD).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival (PFS)</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>The time from the first dose of TQB3912 to the first occurrence of disease progression or death from any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DOR)</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>The time from first documented response to documented disease progression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>The time between the date of first administration and the date of death due to any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to reach maximum (peak) plasma concentration (Tmax)</measure>
      <time_frame>Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.</time_frame>
      <description>To characterize the pharmacokinetics of TQB3912 by assessment of time to reach maximum plasma concentration after single and multiple dosing.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum (peak) plasma drug concentration (Cmax)</measure>
      <time_frame>Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.</time_frame>
      <description>Cmax is the maximum plasma concentration of TQB3912 or metabolite(s).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)</measure>
      <time_frame>Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.</time_frame>
      <description>Cmax,ss is the maximum steady-state plasma concentration of TQB3912 or metabolite(s).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the plasma concentration-time curve from time zero to time t (AUC0-t)</measure>
      <time_frame>Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.</time_frame>
      <description>To characterize the pharmacokinetics of TQB3912 by assessment of area under the plasma concentration time curve from the first dose to time t.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Elimination half-life (t1/2) (to be used in one-or non- compartmental model)</measure>
      <time_frame>Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.</time_frame>
      <description>t1/2 is time it takes for the blood concentration of TQB3912 or metabolite(s) to drop by half.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">88</enrollment>
    <condition>Advanced Malignant Neoplasm</condition>
    <arm_group>
      <arm_group_label>TQB3912 tablets</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>TQB3912 tablets, 28 days as a treatment cycle.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>TQB3912 tablets</intervention_name>
      <description>TQB3912 is a small molecule Phosphorylated protein kinase inhibitor. Activation of the pathway plays an important role in cell survival, proliferation, migration, and differentiation.</description>
      <arm_group_label>TQB3912 tablets</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subjects who voluntarily join the study, sign the informed consent form, and have good&#xD;
               compliance.&#xD;
  &#xD;
            -  Aged from 18 to 75 years; Eastern Cooperative Oncology Group performance status score:&#xD;
               0-2; at least 3 months of expected survival period.&#xD;
  &#xD;
            -  Subjects with relapse advanced malignant solid tumors clearly diagnosed by pathology&#xD;
               and/or cytology.&#xD;
  &#xD;
            -  The function of main organs is normal.&#xD;
  &#xD;
            -  Subjects need to adopt effective methods of contraception.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subjects with other malignancies currently or suffered within 3 years.&#xD;
  &#xD;
            -  Subjects with Grade 1 or above unhealed toxicity reaction of Common Terminology&#xD;
               Criteria for Adverse Events Version 5.0 due to previous antitumor treatment.&#xD;
  &#xD;
            -  Subjects who have received major surgical treatment, open biopsy or obvious traumatic&#xD;
               injury within 28 days before first administration.&#xD;
  &#xD;
            -  Subjects with long lasting wounds or fractures.&#xD;
  &#xD;
            -  Subjects with a history of psychotropic drug abuse unable to quit or with mental&#xD;
               disorders.&#xD;
  &#xD;
            -  Subjects with any severe and/or uncontrolled disease.&#xD;
  &#xD;
            -  Subjects who have received surgery, chemotherapy, radiotherapy or other anticancer&#xD;
               therapies 4 weeks before the first administration.&#xD;
  &#xD;
            -  Subjects who have taken Chinese patent medicines with anti-tumor indications in the&#xD;
               drug instructions that National Medical Products Administration approved within 2&#xD;
               weeks before the first administration.&#xD;
  &#xD;
            -  Subjects with pleural effusion, pericardial effusion or ascites that cannot be&#xD;
               controlled and need repeated drainage.&#xD;
  &#xD;
            -  Subjects who have participated in other clinical studies within 4 weeks before the&#xD;
               first administration.&#xD;
  &#xD;
            -  According to the judgment of the investigators, there are accompanying diseases that&#xD;
               seriously endanger the safety of patients or affect the completion 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>Qiang Wei, Doctor</last_name>
      <phone>+86 028-85422449</phone>
      <email>wq933@hotmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Quchang Ouyang, Doctor</last_name>
      <phone>+86 13973135318</phone>
      <email>oyqc1969@126.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hunan Cancer Hospital</name>
        <address>
          <city>Changsha</city>
          <state>Hunan</state>
          <zip>410013</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Quchang Ouyang, Doctor</last_name>
        <phone>+86 13973135318</phone>
        <email>oyqc1969@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>West China hospital, Sichuan university</name>
        <address>
          <city>Chengdu</city>
          <state>Sichuan</state>
          <zip>610000</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Qiang Wei, Doctor</last_name>
        <phone>+86 028-85422449</phone>
        <email>wq933@hotmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Ping Feng, Doctor</last_name>
        <phone>+86 028-85423583</phone>
        <email>617130961@qq.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 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>Neoplasms</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05997342
  org study id: TQB3912-I-01
  nct id: NCT05997342
  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 (AEs) and serious adverse events (SAEs), pharmacokinetic parameters and antitumor
        effect of TQB3912 tablets in Chinese adult patients with advanced malignant neoplasm. The
        study was divided into phase Ia and phase Ib, Phase Ia: Dose escalation period, to evaluate
        the safety and tolerability of TQB3912 tablets, determine MTD; Phase Ib: Effectiveness
        exploration period, to expand the safe and effective dose group, and to recommend appropriate
        dosage and method for subsequent clinical research.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Dose Limiting Toxicities (DLT)
  time frame: During the first 28 days.
  description: Subjects within 28 days after treatment appear the following toxicity reaction relate to the drug: grade III or above of non-hematological toxicity, grade III hematological toxicity, Neutropenia associated with fever.
  measure: Maximum tolerated dose (MTD)
  time frame: During the first 29 days.
  description: MTD is defined as the highest dosing schedule cohort level at which no more than 1 of 6 patients experience a Dose Limiting Toxicity (DLT).
  measure: Overall response rate (ORR)
  time frame: Up to 2 years
  description: From the first drug treatment to the last drug treatment.
  measure: Incidence of adverse events (AEs)
  time frame: From the time of informed consent signed to 90 days after the last dose
  description: Number of patients with adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
  measure: Incidence of serious adverse events (SAEs)
  time frame: From the time of informed consent signed to 90 days after the last dose
  description: Number of patients with serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
  measure: Disease control rate (DCR)
  time frame: Up to 2 years
  description: The proportion of subjects with Complete response (CR), Partial response (PR), or Stable Disease (SD).
  measure: Progression-free survival (PFS)
  time frame: Up to 2 years
  description: The time from the first dose of TQB3912 to the first occurrence of disease progression or death from any cause.
  measure: Duration of Response (DOR)
  time frame: Up to 2 years
  description: The time from first documented response to documented disease progression.
  measure: Overall survival (OS)
  time frame: Up to 5 years
  description: The time between the date of first administration and the date of death due to any cause.
  measure: Time to reach maximum (peak) plasma concentration (Tmax)
  time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.
  description: To characterize the pharmacokinetics of TQB3912 by assessment of time to reach maximum plasma concentration after single and multiple dosing.
  measure: Maximum (peak) plasma drug concentration (Cmax)
  time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.
  description: Cmax is the maximum plasma concentration of TQB3912 or metabolite(s).
  measure: Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)
  time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.
  description: Cmax,ss is the maximum steady-state plasma concentration of TQB3912 or metabolite(s).
  measure: Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
  time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.
  description: To characterize the pharmacokinetics of TQB3912 by assessment of area under the plasma concentration time curve from the first dose to time t.
  measure: Elimination half-life (t1/2) (to be used in one-or non- compartmental model)
  time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on single dose; pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48 and 72 hours after-dose on multiple dose of day 28.
  description: t1/2 is time it takes for the blood concentration of TQB3912 or metabolite(s) to drop by half.
  arm group label: TQB3912 tablets
  arm group type: Experimental
  description: TQB3912 tablets, 28 days as a treatment cycle.
  intervention type: Drug
  intervention name: TQB3912 tablets
  description: TQB3912 is a small molecule Phosphorylated protein kinase inhibitor. Activation of the pathway plays an important role in cell survival, proliferation, migration, and differentiation.
  arm group label: TQB3912 tablets
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Qiang Wei, Doctor
  phone: +86 028-85422449
  email: wq933@hotmail.com
  last name: Quchang Ouyang, Doctor
  phone: +86 13973135318
  email: oyqc1969@126.com
  facility: 
  contact: 
  facility: 
  contact: 
  contact backup: 
  country: China
  responsible party type: Sponsor
  mesh term: Neoplasms