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/NCT06019013</url>
    </required_header>
    <id_info>
      <org_study_id>QLF3108-101</org_study_id>
      <nct_id>NCT06019013</nct_id>
    </id_info>
    <brief_title>A Study of QLF3108 in Participants With Advanced Solid Tumor</brief_title>
    <official_title>A Phase 1 Study to Evaluate the Safety and Efficacy Investigate the Immunogenicity and Pharmacokinetic Characteristics of QLF3108 Injection in Patients With Advanced Solid Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Qilu Pharmaceutical Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Qilu Pharmaceutical 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>
        This study will evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of&#xD;
        QLF3108 and will make a preliminary assessment of the anti-tumor activity of QLF3108 in&#xD;
        patients with advanced solid tumor.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a single-arm, open-label, Phase 1, dose escalation and Pharmacokinetics (PK)&#xD;
        expansion study of QLF3108 in subjects with advanced solid tumor, to determine the&#xD;
        dose-limiting toxicity (DLT), the maximum tolerated dose (MTD) and establish a recommended&#xD;
        Phase 2 dose (RP2D) of QLF3108. The purpose of this study is to describe the safety and&#xD;
        tolerability, assess pharmacokinetics parameters and immunogenicity, and assess the&#xD;
        anti-tumor activity of QLF3108 in subjects with advanced solid tumor.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 16, 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2025</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>DLTs of QLF3108</measure>
      <time_frame>Approximately 24 months</time_frame>
      <description>dose-limiting toxicity</description>
    </primary_outcome>
    <primary_outcome>
      <measure>MTD(s) of QLF3108</measure>
      <time_frame>Approximately 24 months</time_frame>
      <description>the maximum tolerated dose</description>
    </primary_outcome>
    <primary_outcome>
      <measure>RP2D of QLF3108</measure>
      <time_frame>Approximately 24 months</time_frame>
      <description>a recommended Phase 2 dose</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The number, rates and severity of participants with Treatment-emergent Adverse Events (TEAEs) according to NCI-CTCAE V5.0</measure>
      <time_frame>Approximately 24 month</time_frame>
      <description>The number, rates and severity of participants with Treatment-emergent Adverse Events (TEAEs) according to NCI-CTCAE V5.0</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The number, rates and severity of participants with Serious Adverse Events (SAEs) according to NCI-CTCAE V5.0</measure>
      <time_frame>Approximately 24 month</time_frame>
      <description>The number, rates and severity of participants with Serious Adverse Events (SAEs) according to NCI-CTCAE V5.0</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cmax of QLF3108</measure>
      <time_frame>Approximately 24 month</time_frame>
      <description>Pharmacokinetics of QLF3108 by assessment of maximum plasma QLF3108 concentration.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tmax of QLF3108</measure>
      <time_frame>Approximately 24 month</time_frame>
      <description>Pharmacokinetics of QLF3108 by assessment of time to Cmax</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the plasma concentration-time curve (AUC) of QLF3108</measure>
      <time_frame>Approximately 24 month</time_frame>
      <description>Pharmacokinetics of QLF3108 by assessment of area under the plasma concentration time curve from zero to infinity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tl/2 of QLF3108</measure>
      <time_frame>Approximately 24 month</time_frame>
      <description>Pharmacokinetics of QLF3108 by assessment of the terminal half-life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Response Rate (ORR)</measure>
      <time_frame>Approximately 24 months</time_frame>
      <description>ORR is defined as the proportion of patients with a complete response (CR) or partial response (PR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DOR)</measure>
      <time_frame>Approximately 24 months</time_frame>
      <description>DOR defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival (PFS)</measure>
      <time_frame>Approximately 24 months</time_frame>
      <description>PFS defined as the time from baseline to first observed disease progression or death from any cause</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival time (OS)</measure>
      <time_frame>Approximately 24 months</time_frame>
      <description>Overall survival (OS) is the time between the subject's first infusion QLF3108 injection and death from any cause.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">78</enrollment>
    <condition>Advanced Solid Tumor</condition>
    <arm_group>
      <arm_group_label>Dose-Escalation Stage and PK-Expansion Stage</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Dose-Escalation Stage：Participants will be assigned sequentially to escalating doses of QLF3108, up to the maximum tolerated dose (MTD).&#xD;
  PK-Expansion Stage：1-4 recommended expansion dose will be proposed for the PK-expansion stage of the trial.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>QLF3108</intervention_name>
      <description>QLF3108 will be administered independent of body weight.</description>
      <arm_group_label>Dose-Escalation Stage and PK-Expansion Stage</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. The volunteer has fully given informed consent to the study and voluntarily signed the&#xD;
               informed consent form prior to trial.&#xD;
  &#xD;
            2. ≥18 years old and body weight ≥40 kg; Female or male.&#xD;
  &#xD;
            3. Histologically or cytologically documented advanced solid tumor;&#xD;
  &#xD;
            4. Failed to standard therapy or intolerance, or lack standard therapy advanced solid&#xD;
               tumors.&#xD;
  &#xD;
            5. Eastern Cooperative Oncology Group（ECOG） performance status of 0 or 1.&#xD;
  &#xD;
            6. Life expectancy of at least 12 weeks.&#xD;
  &#xD;
            7. Adequate hematologic and end organ function.&#xD;
  &#xD;
            8. Female subjects who are not pregnant or not breastfeeding. A negative blood pregnancy&#xD;
               test for females of childbearing potential within 7 days prior to first dosing.&#xD;
  &#xD;
            9. Male and female subjects of childbearing potential must agree to use highly effective&#xD;
               method of contraception during the entire course of the study and within 180 days&#xD;
               after the end of the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients that have previously received cancer therapy within 4 weeks prior to the&#xD;
               first dose of the investigational drug.&#xD;
  &#xD;
            2. Patient has received other investigational drug or other clinical trial treatment&#xD;
               within 4 weeks prior to the first dose of the investigational drug.&#xD;
  &#xD;
            3. Active autoimmune disease that has required systemic treatment within 2 years prior to&#xD;
               this study.&#xD;
  &#xD;
            4. A live vaccine or live attenuated vaccine was administered within 30 days prior to the&#xD;
               first dose of the investigational drug.&#xD;
  &#xD;
            5. Patients with Adverse Events(AEs) from previous treatment that have not recovered to&#xD;
               ≤1(CTCAE 5.0）; or are unstable status.&#xD;
  &#xD;
            6. Severe concomitant medical condition for bowel obstruction, or implanted colon stent&#xD;
               during screening period.&#xD;
  &#xD;
            7. Patients with a history of HIV positive or other immunodeficiency. Or patients with&#xD;
               the history of organ transplant or allogeneic bone marrow (excluding corneal&#xD;
               transplantation).&#xD;
  &#xD;
            8. Patients with a history of psychiatric disorders, or epilepsy or dementia, drug or&#xD;
               alcohol abuse, may impact patient completion of the study.&#xD;
  &#xD;
            9. Patients may interfere with the interpretation of study results as determined by the&#xD;
               investigator, or are unable to participate in the whole study, or deemed unsuitable by&#xD;
               the investigator.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Xu Jianming, M.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>Chinese People's Liberation Army (PLA) General Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xu Jianming, M.D</last_name>
      <phone>13910866712</phone>
      <email>Jianmingxu2014@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Chinese People's Liberation Army (PLA) General Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xu Jianming, M.D</last_name>
        <phone>13910866712</phone>
        <email>Jianmingxu2014@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 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/NCT06019013
  org study id: QLF3108-101
  nct id: NCT06019013
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study will evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of
        QLF3108 and will make a preliminary assessment of the anti-tumor activity of QLF3108 in
        patients with advanced solid tumor.
  This is a single-arm, open-label, Phase 1, dose escalation and Pharmacokinetics (PK)
        expansion study of QLF3108 in subjects with advanced solid tumor, to determine the
        dose-limiting toxicity (DLT), the maximum tolerated dose (MTD) and establish a recommended
        Phase 2 dose (RP2D) of QLF3108. The purpose of this study is to describe the safety and
        tolerability, assess pharmacokinetics parameters and immunogenicity, and assess the
        anti-tumor activity of QLF3108 in subjects with advanced solid tumor.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: DLTs of QLF3108
  time frame: Approximately 24 months
  description: dose-limiting toxicity
  measure: MTD(s) of QLF3108
  time frame: Approximately 24 months
  description: the maximum tolerated dose
  measure: RP2D of QLF3108
  time frame: Approximately 24 months
  description: a recommended Phase 2 dose
  measure: The number, rates and severity of participants with Treatment-emergent Adverse Events (TEAEs) according to NCI-CTCAE V5.0
  time frame: Approximately 24 month
  description: The number, rates and severity of participants with Treatment-emergent Adverse Events (TEAEs) according to NCI-CTCAE V5.0
  measure: The number, rates and severity of participants with Serious Adverse Events (SAEs) according to NCI-CTCAE V5.0
  time frame: Approximately 24 month
  description: The number, rates and severity of participants with Serious Adverse Events (SAEs) according to NCI-CTCAE V5.0
  measure: Cmax of QLF3108
  time frame: Approximately 24 month
  description: Pharmacokinetics of QLF3108 by assessment of maximum plasma QLF3108 concentration.
  measure: Tmax of QLF3108
  time frame: Approximately 24 month
  description: Pharmacokinetics of QLF3108 by assessment of time to Cmax
  measure: Area under the plasma concentration-time curve (AUC) of QLF3108
  time frame: Approximately 24 month
  description: Pharmacokinetics of QLF3108 by assessment of area under the plasma concentration time curve from zero to infinity
  measure: Tl/2 of QLF3108
  time frame: Approximately 24 month
  description: Pharmacokinetics of QLF3108 by assessment of the terminal half-life
  measure: Overall Response Rate (ORR)
  time frame: Approximately 24 months
  description: ORR is defined as the proportion of patients with a complete response (CR) or partial response (PR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
  measure: Duration of Response (DOR)
  time frame: Approximately 24 months
  description: DOR defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
  measure: Progression-free survival (PFS)
  time frame: Approximately 24 months
  description: PFS defined as the time from baseline to first observed disease progression or death from any cause
  measure: Overall survival time (OS)
  time frame: Approximately 24 months
  description: Overall survival (OS) is the time between the subject's first infusion QLF3108 injection and death from any cause.
  arm group label: Dose-Escalation Stage and PK-Expansion Stage
  arm group type: Experimental
  description: Dose-Escalation Stage：Participants will be assigned sequentially to escalating doses of QLF3108, up to the maximum tolerated dose (MTD).
  PK-Expansion Stage：1-4 recommended expansion dose will be proposed for the PK-expansion stage of the trial.
  intervention type: Drug
  intervention name: QLF3108
  description: QLF3108 will be administered independent of body weight.
  arm group label: Dose-Escalation Stage and PK-Expansion Stage
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Xu Jianming, M.D
  role: Principal Investigator
  affiliation: Chinese People's Liberation Army (PLA) General Hospital
  last name: Xu Jianming, M.D
  phone: 13910866712
  email: Jianmingxu2014@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Neoplasms