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/NCT05963386</url>
    </required_header>
    <id_info>
      <org_study_id>XMFHIIT-2023KY037</org_study_id>
      <nct_id>NCT05963386</nct_id>
    </id_info>
    <brief_title>Clinical Evaluation of 177Lu-DOTA-EB-FAPI in Patients With Various Solid Tumors</brief_title>
    <official_title>An Open-Label, Non-Randomized, Single-Center, Investigator-Initiated Trial to Determine the Safety, Dosimetry, and Preliminary Effectiveness of 177Lu-DOTA-EB-FAPI in Patients With Various Solid Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The First Affiliated Hospital of Xiamen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The First Affiliated Hospital of Xiamen University</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>
        Increased fibroblast activation protein expression is positively correlated with the&#xD;
        aggressiveness of cancer. Radiolabeled fibroblast activation protein inhibitor therapy, also&#xD;
        known as radioligand therapy has become a novel treatment for patients with refractory cancer&#xD;
        and disease progression after multiple-lines treatment. However, a major problem in the&#xD;
        therapeutic use of 177Lu-DOTA-FAPI has been its short half-life and fast rate of clearance.&#xD;
        This study was designed to evaluate the safety and tolerabilityof a long-lasting radiolabeled&#xD;
        fibroblast activation protein inhibitor 177Lu-DOTA-EB-FAPI in patients with various&#xD;
        refractory solid tumors.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This IIT study will include a maximum of 20 subjects with progressive cancer after&#xD;
        multiple-line treatment, with an increased radiotracer uptake in tumors on 68Ga-FAPI-46&#xD;
        PET/CT. The fixed dose of 177Lu-DOTA-EB-FAPI is 3.7GBq (100 mCi). Treatment is planned for up&#xD;
        to 2 cycles, and the time interval between cycles is 6 weeks. The primary endpoint assessed&#xD;
        the safety and maximum tolerated dose of 177Lu-DOTA-EB-FAPI used for radioligand therapy in&#xD;
        patients with various advanced tumors. Secondary endpoints included dosimetry and&#xD;
        determination of the preliminary treatment efficacy of 177Lu-DOTA-EB-FAPI.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 22, 2023</start_date>
    <completion_date type="Anticipated">June 15, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 15, 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>Incidence of treatment-related adverse events (safety and tolerability)</measure>
      <time_frame>At the end of Cycle 2 (each cycle is 42 days)</time_frame>
      <description>Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. Dose-limiting toxicity was defined as any 177Lu-DOTA-EB-FAPI-related AE ≥ grade 3 (G3). For Hemoglobin &lt; 8.0 g/dL; &lt; 4.9 mmol/L; &lt; 80 g/L; Need blood transfusion heal. Severe hypocytosis or with this age group The total number of normal cells was reduced &gt;50% and ≤75%.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Objective response rate (ORR)</measure>
      <time_frame>At the end of Cycle 2 (each cycle is 42 days)</time_frame>
      <description>68Ga-Fibroblast activation protein inhibitor 46 will be performed for efficacy evaluation by RECIST 1.1. Particularly, 68Ga-FAPI-46 will be performed at baseline, and 6 weeks after two treatment cycles.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dosimetry</measure>
      <time_frame>At the end of Cycle 1 (each cycle is 42 days)</time_frame>
      <description>Dosimetry, measured as absorbed dose in tumor and normal organs (Gy/GBq), was estimated in the first treatment cycle for each patient.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Refractory Solid Tumor</condition>
    <arm_group>
      <arm_group_label>177Lu-DOTA-EB-FAPI</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>177Lu-DOTA-EB-FAPI A maximum of 2 cycles of 100 mCi (3.7 GBq) 177Lu-DOTA-EB-FAPI, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 2 cycles, every 6 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>177Lu-DOTA-EB-FAPI radionuclide therapy</intervention_name>
      <description>radionuclide therapy using 177Lu-DOTA-EB-FAPI 100 mCi (3.7 GBq) will be performed 6-weekly. A maximum of 2 cycles will be administered.</description>
      <arm_group_label>177Lu-DOTA-EB-FAPI</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Ability to understand and willingness to sign a written informed consent document.&#xD;
  &#xD;
            -  Age 18 and older.&#xD;
  &#xD;
            -  Confirmed unresectable or metastatic refractory cancer with measurable disease per&#xD;
               RECIST (version 1.1) (i.e. at least 1 lesion &gt; 1 cm or lymph node &gt; 1.5 cm in short&#xD;
               axis).&#xD;
  &#xD;
            -  Progressive disease after multiple-lines treatment.&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group Performance Status ≤ 3.&#xD;
  &#xD;
            -  Participant must have completed prior therapy at least 2 weeks (washout period) prior&#xD;
               to 68Ga-FAPI-46 PET/CT scan. Any clinically significant toxicity (with the exceptions&#xD;
               of hair loss and sensory neuropathy) related to prior therapy resolved below Grade 2&#xD;
               or baseline. Completion of entry into 68Ga-FAPI-46 study and completion of scan.&#xD;
  &#xD;
            -  Hematologic parameters defined as: Absolute neutrophil count (ANC) ≥ 1000 cells/mm3&#xD;
               Platelet count ≥ 50,000/mm3 Hemoglobin ≥ 8 g/dL.&#xD;
  &#xD;
            -  Blood chemistry levels defined as: AST, ALT, alkaline phosphatase ≤ 5 times upper&#xD;
               limit of normal (ULN) Total bilirubin ≤ 3 times ULN Creatinine ≤ 3 times ULN Able to&#xD;
               remain motionless for up to 30-60 minutes per scan.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participant on any chemical anticoagulant including antiplatelet agents (excluding&#xD;
               ASA).&#xD;
  &#xD;
            -  Participants with Class 3 or 4 NYHA Congestive Heart Failure.&#xD;
  &#xD;
            -  Clinically significant bleeding within two weeks prior to trial entry (e.g.&#xD;
               gastrointestinal bleeding, intracranial bleeding).&#xD;
  &#xD;
            -  Pregnant or lactating women.&#xD;
  &#xD;
            -  Major surgery, defined as any surgical procedure that involves general anesthesia and&#xD;
               a significant incision (i.e. larger than what is required for placement of a central&#xD;
               venous access, percutaneous feeding tube, or biopsy) within 28 days prior to study day&#xD;
               1 or anticipated surgery within the subsequent 6 weeks.&#xD;
  &#xD;
            -  Has an additional active malignancy requiring therapy within the past 2 years.&#xD;
  &#xD;
            -  Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic&#xD;
               therapy.&#xD;
  &#xD;
            -  Psychiatric illness/social situations that would interfere with compliance with study&#xD;
               requirements&#xD;
  &#xD;
            -  Cannot undergo PET/CT scanning because of weight limits (350 lbs).&#xD;
  &#xD;
            -  INR&gt;1.2; PTT&gt;5 seconds above UNL.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jingxiong Huang, MD.</last_name>
      <phone>+8613806082344</phone>
      <email>huang_hjx9@126.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Hao Fu, MD, PhD</last_name>
      <phone>+8615959230059</phone>
      <email>fuhaonuclear@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Xiamen University</name>
        <address>
          <city>Xiamen</city>
          <state>Fujian</state>
          <zip>361000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jingxiong Huang, MD</last_name>
        <phone>+8613806082344</phone>
        <email>huang_hjx9@126.com</email>
      </contact>
      <investigator>
        <last_name>Jingxiong Huang, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Refractory solid tumor</keyword>
    <keyword>Radioligand therapy</keyword>
    <keyword>177Lu-DOTA-EB-FAPI</keyword>
    <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/NCT05963386
  org study id: XMFHIIT-2023KY037
  nct id: NCT05963386
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Increased fibroblast activation protein expression is positively correlated with the
        aggressiveness of cancer. Radiolabeled fibroblast activation protein inhibitor therapy, also
        known as radioligand therapy has become a novel treatment for patients with refractory cancer
        and disease progression after multiple-lines treatment. However, a major problem in the
        therapeutic use of 177Lu-DOTA-FAPI has been its short half-life and fast rate of clearance.
        This study was designed to evaluate the safety and tolerabilityof a long-lasting radiolabeled
        fibroblast activation protein inhibitor 177Lu-DOTA-EB-FAPI in patients with various
        refractory solid tumors.
  This IIT study will include a maximum of 20 subjects with progressive cancer after
        multiple-line treatment, with an increased radiotracer uptake in tumors on 68Ga-FAPI-46
        PET/CT. The fixed dose of 177Lu-DOTA-EB-FAPI is 3.7GBq (100 mCi). Treatment is planned for up
        to 2 cycles, and the time interval between cycles is 6 weeks. The primary endpoint assessed
        the safety and maximum tolerated dose of 177Lu-DOTA-EB-FAPI used for radioligand therapy in
        patients with various advanced tumors. Secondary endpoints included dosimetry and
        determination of the preliminary treatment efficacy of 177Lu-DOTA-EB-FAPI.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence of treatment-related adverse events (safety and tolerability)
  time frame: At the end of Cycle 2 (each cycle is 42 days)
  description: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. Dose-limiting toxicity was defined as any 177Lu-DOTA-EB-FAPI-related AE ≥ grade 3 (G3). For Hemoglobin < 8.0 g/dL; < 4.9 mmol/L; < 80 g/L; Need blood transfusion heal. Severe hypocytosis or with this age group The total number of normal cells was reduced >50% and ≤75%.
  measure: Objective response rate (ORR)
  time frame: At the end of Cycle 2 (each cycle is 42 days)
  description: 68Ga-Fibroblast activation protein inhibitor 46 will be performed for efficacy evaluation by RECIST 1.1. Particularly, 68Ga-FAPI-46 will be performed at baseline, and 6 weeks after two treatment cycles.
  measure: Dosimetry
  time frame: At the end of Cycle 1 (each cycle is 42 days)
  description: Dosimetry, measured as absorbed dose in tumor and normal organs (Gy/GBq), was estimated in the first treatment cycle for each patient.
  arm group label: 177Lu-DOTA-EB-FAPI
  arm group type: Experimental
  description: 177Lu-DOTA-EB-FAPI A maximum of 2 cycles of 100 mCi (3.7 GBq) 177Lu-DOTA-EB-FAPI, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 2 cycles, every 6 weeks
  intervention type: Drug
  intervention name: 177Lu-DOTA-EB-FAPI radionuclide therapy
  description: radionuclide therapy using 177Lu-DOTA-EB-FAPI 100 mCi (3.7 GBq) will be performed 6-weekly. A maximum of 2 cycles will be administered.
  arm group label: 177Lu-DOTA-EB-FAPI
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Jingxiong Huang, MD.
  phone: +8613806082344
  email: huang_hjx9@126.com
  last name: Hao Fu, MD, PhD
  phone: +8615959230059
  email: fuhaonuclear@163.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: China
  responsible party type: Sponsor
  mesh term: Neoplasms