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/NCT06010342</url>
    </required_header>
    <id_info>
      <org_study_id>TL-TRK-202101</org_study_id>
      <nct_id>NCT06010342</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Efficacy and Safety of TL118 in Solid Tumors Patients</brief_title>
    <official_title>A Phase 2 Study of TL118 for the Treatment of Patients With Solid Tumors Harboring NTRK Gene Fusions</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Teligene US</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Teligene US</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The main objective of the study will be to evaluate the efficacy of TL118 in participants&#xD;
        with solid tumors harboring NTRK gene fusions&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        TL118 is an orally active inhibitor of the tropomyosin receptor kinase (Trk) family consists&#xD;
        of TrkA, TrkB, and TrkC. These receptors are encoded by the NTRK1, NTRK2 and NTRK3 genes, and&#xD;
        oncogenic fusions of NTRK may cause cancer cells to grow and spread in the body. The purpose&#xD;
        of this study is to explore how effective TL118 is for the treatment of patients with solid&#xD;
        tumors harboring NTRK gene fusions.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2025</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>Objective Response Rate (ORR)</measure>
      <time_frame>Pre-dose up to approximately 24 months post-dose</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DoR)</measure>
      <time_frame>Pre-dose up to approximately 24 months post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease Control Rate (DCR)</measure>
      <time_frame>Pre-dose up to approximately 24 months post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression Free Survival (PFS)</measure>
      <time_frame>Pre-dose up to approximately 24 months post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to Tumor Progression (TTP)</measure>
      <time_frame>Pre-dose up to approximately 24 months post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to Response (TTR)</measure>
      <time_frame>Pre-dose up to approximately 24 months post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to Treatment Failure (TTF)</measure>
      <time_frame>Pre-dose up to approximately 24 months post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Survival (OS)</measure>
      <time_frame>Pre-dose up to approximately 24 months post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>1-year Progression Free Survival</measure>
      <time_frame>Pre-dose up to approximately 24 months post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>1-year Survival</measure>
      <time_frame>Pre-dose up to approximately 24 months post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants Experiencing Adverse Events (AE)</measure>
      <time_frame>Pre-dose up to approximately 24 months post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants Experiencing Adverse Drug Reactions (ADR)</measure>
      <time_frame>Pre-dose up to approximately 24 months post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants Experiencing Serious Adverse Events (SAE)</measure>
      <time_frame>Pre-dose up to approximately 24 months post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants Experiencing Serious Adverse Reactions (SAR)</measure>
      <time_frame>Pre-dose up to approximately 24 months post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area Under The Curve (AUC) of TL118</measure>
      <time_frame>Pre-dose up to 12 hours post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum Plasma Concentration (Cmax) of TL118</measure>
      <time_frame>Pre-dose up to 12 hours post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Minimum Plasma Concentration (Cmin) of TL118</measure>
      <time_frame>Pre-dose up to 12 hours post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to Peak Drug Concentration (Tmax) of TL118</measure>
      <time_frame>Pre-dose up to 12 hours post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TL118 half-life (T1/2)</measure>
      <time_frame>Pre-dose up to 12 hours post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apparent Clearance (CL/f) of TL118</measure>
      <time_frame>Pre-dose up to 12 hours post-dose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Volume of Distribution (Vz/F) of TL118</measure>
      <time_frame>Pre-dose up to 12 hours post-dose</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Solid Tumor</condition>
    <arm_group>
      <arm_group_label>Single arm, Open label</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive TL118 capsule taken orally with (preferred) or without food, 252 mg twice daily, 28 days for a cycle.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>TL118 Capsule</intervention_name>
      <description>Oral administration</description>
      <arm_group_label>Single arm, Open label</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18 years old and above, male or female&#xD;
  &#xD;
            2. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic&#xD;
               solid tumor that harbors an NTRK1/2/3 gene fusion that is predicted to translate into&#xD;
               a fusion protein with a functional tropomyosin receptor kinase (TRK)A/B/C kinase&#xD;
               domain, without a concomitant second onco-driver&#xD;
  &#xD;
            3. 3) Patients must have had disease progression during or after prior treatment for&#xD;
               their tumor, or would be unlikely to tolerate or derive clinical benefit from&#xD;
               appropriate standard of care therapy or are not suitable - in the opinion of the&#xD;
               Investigator - to receive standard of care therapy; prior treatment with approved or&#xD;
               investigational TRK inhibitors in patients who have tumors that harbor NTRK1/2/3 gene&#xD;
               rearrangements is not allowed, except for prior TRK treatment for less than 28 days&#xD;
               due to intolerable toxicity)&#xD;
  &#xD;
            4. At least one measurable lesion&#xD;
  &#xD;
            5. Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2&#xD;
  &#xD;
            6. A minimum life expectancy of &gt; 3 months&#xD;
  &#xD;
            7. Adequate bone marrow reserve, hepatic, renal, and coagulation function&#xD;
  &#xD;
          Other inclusion criteria apply for participating in the Study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Any systemic anti-tumor therapy such as chemotherapy and radiation therapy (including&#xD;
               curative radiotherapy or spinal radiotherapy portion &gt; 30%) used within 3 weeks prior&#xD;
               to enrollment; immunotherapy within 4 weeks; any palliative radiotherapy for&#xD;
               non-target lesions used to relieve symptoms and traditional Chinese medicines (TCMs)&#xD;
               indicated for the tumor (including Chinese patent medicine) within 2 weeks prior to&#xD;
               enrollment&#xD;
  &#xD;
            2. Participation in another interventional clinical trial 2 weeks prior to enrollment or&#xD;
               within 5 half-lives from the last dose of IP (whichever is shorter)&#xD;
  &#xD;
            3. Any unresolved toxicities from prior therapy greater than Grade 1, at the time of&#xD;
               screening with the exception of toxicities posing no safety risk in the opinion of the&#xD;
               Investigator&#xD;
  &#xD;
            4. Active central nervous system metastases&#xD;
  &#xD;
            5. Any other primary malignant tumors within 3 years (except for cured skin basal cell&#xD;
               carcinoma and carcinoma in situ of cervix, low-risk cancer&#xD;
  &#xD;
            6. Any active infection which has not been controlled at screening&#xD;
  &#xD;
          Other exclusion criteria apply for participating in the Study&#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_contact>
      <last_name>Xiaoyang Xia</last_name>
      <phone>8053009373</phone>
      <email>xiaoyang.xia@teligene.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Dawei Zhang</last_name>
      <phone>8053001019</phone>
      <email>david.zhang@teligene.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Oncology</keyword>
    <keyword>TL118</keyword>
    <keyword>Teligene</keyword>
    <keyword>Cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06010342
  org study id: TL-TRK-202101
  nct id: NCT06010342
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The main objective of the study will be to evaluate the efficacy of TL118 in participants
        with solid tumors harboring NTRK gene fusions
  TL118 is an orally active inhibitor of the tropomyosin receptor kinase (Trk) family consists
        of TrkA, TrkB, and TrkC. These receptors are encoded by the NTRK1, NTRK2 and NTRK3 genes, and
        oncogenic fusions of NTRK may cause cancer cells to grow and spread in the body. The purpose
        of this study is to explore how effective TL118 is for the treatment of patients with solid
        tumors harboring NTRK gene fusions.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective Response Rate (ORR)
  time frame: Pre-dose up to approximately 24 months post-dose
  measure: Duration of Response (DoR)
  time frame: Pre-dose up to approximately 24 months post-dose
  measure: Disease Control Rate (DCR)
  time frame: Pre-dose up to approximately 24 months post-dose
  measure: Progression Free Survival (PFS)
  time frame: Pre-dose up to approximately 24 months post-dose
  measure: Time to Tumor Progression (TTP)
  time frame: Pre-dose up to approximately 24 months post-dose
  measure: Time to Response (TTR)
  time frame: Pre-dose up to approximately 24 months post-dose
  measure: Time to Treatment Failure (TTF)
  time frame: Pre-dose up to approximately 24 months post-dose
  measure: Overall Survival (OS)
  time frame: Pre-dose up to approximately 24 months post-dose
  measure: 1-year Progression Free Survival
  time frame: Pre-dose up to approximately 24 months post-dose
  measure: 1-year Survival
  time frame: Pre-dose up to approximately 24 months post-dose
  measure: Number of Participants Experiencing Adverse Events (AE)
  time frame: Pre-dose up to approximately 24 months post-dose
  measure: Number of Participants Experiencing Adverse Drug Reactions (ADR)
  time frame: Pre-dose up to approximately 24 months post-dose
  measure: Number of Participants Experiencing Serious Adverse Events (SAE)
  time frame: Pre-dose up to approximately 24 months post-dose
  measure: Number of Participants Experiencing Serious Adverse Reactions (SAR)
  time frame: Pre-dose up to approximately 24 months post-dose
  measure: Area Under The Curve (AUC) of TL118
  time frame: Pre-dose up to 12 hours post-dose
  measure: Maximum Plasma Concentration (Cmax) of TL118
  time frame: Pre-dose up to 12 hours post-dose
  measure: Minimum Plasma Concentration (Cmin) of TL118
  time frame: Pre-dose up to 12 hours post-dose
  measure: Time to Peak Drug Concentration (Tmax) of TL118
  time frame: Pre-dose up to 12 hours post-dose
  measure: TL118 half-life (T1/2)
  time frame: Pre-dose up to 12 hours post-dose
  measure: Apparent Clearance (CL/f) of TL118
  time frame: Pre-dose up to 12 hours post-dose
  measure: Volume of Distribution (Vz/F) of TL118
  time frame: Pre-dose up to 12 hours post-dose
  arm group label: Single arm, Open label
  arm group type: Experimental
  description: Participants will receive TL118 capsule taken orally with (preferred) or without food, 252 mg twice daily, 28 days for a cycle.
  intervention type: Drug
  intervention name: TL118 Capsule
  description: Oral administration
  arm group label: Single arm, Open label
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Xiaoyang Xia
  phone: 8053009373
  email: xiaoyang.xia@teligene.com
  last name: Dawei Zhang
  phone: 8053001019
  email: david.zhang@teligene.com
  responsible party type: Sponsor
  mesh term: Neoplasms
  sharing ipd: No