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/NCT05996952</url>
    </required_header>
    <id_info>
      <org_study_id>2023(24)</org_study_id>
      <nct_id>NCT05996952</nct_id>
    </id_info>
    <brief_title>RC48-ADC in Adjuvant/Salvage Treatment of HER2 Positive Non-muscle-invasive Bladder Cancer</brief_title>
    <official_title>A Multicenter Phase II Study of RC48-ADC in Adjuvant/Salvage Treatment of HER2 Positive High-risk Non-muscle-invasive Bladder Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>West China Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>RemeGen Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>West China Hospital</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 study will evaluate the efficacy and safety of intravenous RC48-ADC in adjuvant/salvage&#xD;
        treatment of HER2 positive high-risk non-muscle-invasive bladder cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a multicenter phase II study, which aims to evaluate the efficacy and safety of&#xD;
        intravenous RC48-ADC in adjuvant/salvage treatment of HER2 positive high-risk&#xD;
        non-muscle-invasive bladder cancer.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2026</completion_date>
    <primary_completion_date type="Anticipated">August 2025</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>12-month recurence-free survival rate</measure>
      <time_frame>From treatment initiation to 12 month</time_frame>
      <description>The probability of patients remaining free of high-risk NMIBC or worse for at least 12 months after first dose of RC48-ADC adjuvant treatment</description>
    </primary_outcome>
    <primary_outcome>
      <measure>3-month pathological complete response rate</measure>
      <time_frame>From treatment initiation to 3 month</time_frame>
      <description>The proportion of patients are negative for urine cytology and cystoscopy at 3 month after first dose of RC48-ADC salvage treatment</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adverse events</measure>
      <time_frame>From patient screening to 30 days after end of cycle 6</time_frame>
      <description>The type, incidence, relatedness, and severity of adverse events</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>6-month recurence-free survival rate</measure>
      <time_frame>From treatment initiation to 6 month</time_frame>
      <description>The probability of patients remaining free of high-risk NMIBC or worse for at least 6 months after first dose of RC48-ADC adjuvant treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response</measure>
      <time_frame>From time of complete response to up to 60 months</time_frame>
      <description>Time from complete response to recurrence of any disease</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Recurrence-free survival</measure>
      <time_frame>From time of first dose of RC48-ADC adjuvant treatment to up to 60 months</time_frame>
      <description>Time from first dose of RC48-ADC adjuvant treatment to high-risk NMIBC recurrence or worse</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival</measure>
      <time_frame>From time of first dose of RC48-ADC treatment to up to 60 months</time_frame>
      <description>Time from first dose of RC48-ADC treatment to progression to higher stage or death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival</measure>
      <time_frame>From time of first dose of RC48-ADC treatment to up to 60 months</time_frame>
      <description>Time from first dose of RC48-ADC treatment to death from any cause</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life assessed by EQ-5D scale</measure>
      <time_frame>After every cycle of treatment and 30 days after end of cycle 6</time_frame>
      <description>Assessed by eEuroQoL EQ-5D scale, higher scores mean better outcomes</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">77</enrollment>
    <condition>Non-muscle Invasive Bladder Cancer</condition>
    <arm_group>
      <arm_group_label>Adjuvant RC48-ADC</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In this arm, RC48-ADC is evaluated in patients with HER2-positive high-risk non-muscle-invasive bladder cancer as an adjuvant treatment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Salvage RC48-ADC</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In this arm, RC48-ADC is evaluated in patients with HER2-positive non-muscle-invasive bladder cancer who failed BCG treatment as an adjuvant treatment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>RC48-ADC</intervention_name>
      <description>Patients are treated with RC48-ADC at 2.0 mg/kg as an intravenous infusion over 30-90 minutes (60 minutes is recommended) once every 2 weeks for 12 weeks.</description>
      <arm_group_label>Adjuvant RC48-ADC</arm_group_label>
      <arm_group_label>Salvage RC48-ADC</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Be willing and able to provide written informed consent/assent for the trial.&#xD;
  &#xD;
            -  Life expectancy ≥12 weeks.&#xD;
  &#xD;
            -  Have a histologically-confirmed diagnosis of high-risk non-muscle-invasive (according&#xD;
               to 2023 NCCN guidelines for bladder cancer) transitional cell carcinoma of the&#xD;
               bladder. Subjects with tumors of mixed transitional/non-transitional cell histology&#xD;
               are allowed, but transitional cell carcinoma must be the predominant histology.&#xD;
  &#xD;
            -  Have been treated with adequate BCG therapy and failed (according to 2023 EAU&#xD;
               guidelines for NMIBC, for salvage treatment arm).&#xD;
  &#xD;
            -  Have elected not to undergo, or are considered ineligible for radical cystectomy, as&#xD;
               determined by the treating surgeon.&#xD;
  &#xD;
            -  Have tumor tissues for HER2 IHC evaluation and have a HER2 expression score of HER2 2+&#xD;
               or HER2 3+ reviewed by an independent pathologist at the central laboratory.&#xD;
  &#xD;
            -  Have a performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group&#xD;
               (ECOG) Performance Scale.&#xD;
  &#xD;
            -  Demonstrate adequate organ function.&#xD;
  &#xD;
            -  Female subjects of childbearing potential must have a negative urine or serum&#xD;
               pregnancy test within 7 days prior to receiving the first dose of study medication.&#xD;
  &#xD;
            -  Male subjects of childbearing potential (Section 5.7.2) must agree to use an adequate&#xD;
               method of contraception starting with the first dose of study therapy through 6 months&#xD;
               after the last dose of study therapy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Has muscle-invasive (i.e. T2, T3, T4) locally advanced non-resectable or metastatic&#xD;
               urothelial carcinoma.&#xD;
  &#xD;
            -  Has concurrent extra-vesical (i.e. urethra, ureter or renal pelvis) non-muscle&#xD;
               invasive transitional cell carcinoma of the urothelium.&#xD;
  &#xD;
            -  Is currently participating and receiving study therapy or has participated in a study&#xD;
               of an investigational agent and received study therapy or used an investigational&#xD;
               device within 4 weeks of the first dose of treatment.&#xD;
  &#xD;
            -  Has undergone any intervening intravesical chemotherapy or immunotherapy from the time&#xD;
               of most recent cystoscopy/TURBT to starting trial treatment. (Note: A single dose of&#xD;
               intravesical treatment given as part of the most recent cystoscopy/TURBT, during the&#xD;
               screening period, such as with chemotherapy as per local / regional practices, is&#xD;
               acceptable.).&#xD;
  &#xD;
            -  Allergic to study therapy.&#xD;
  &#xD;
            -  Has a known additional malignancy that has had progression or has required active&#xD;
               treatment in the last five years.&#xD;
  &#xD;
            -  Has an active autoimmune disease that has required systemic treatment in past 2 years.&#xD;
  &#xD;
            -  Have diseases that may interfere with the study treatment or severe and uncontrolled&#xD;
               concomitant diseases.&#xD;
  &#xD;
            -  Has had an allogeneic tissue/solid organ transplant.&#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_official>
      <last_name>Hao Zeng</last_name>
      <role>Principal Investigator</role>
      <affiliation>West China Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hao Zeng</last_name>
      <phone>8602885422114</phone>
      <email>kucaizeng@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Junru Chen</last_name>
      <phone>8602885422114</phone>
      <email>jrchen@scu.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>West China Hospital</name>
        <address>
          <city>Chengdu</city>
          <state>Sichuan</state>
          <zip>610041</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 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>Principal Investigator</responsible_party_type>
      <investigator_affiliation>West China Hospital</investigator_affiliation>
      <investigator_full_name>Hao Zeng</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Urinary Bladder Neoplasms</mesh_term>
      <mesh_term>Non-Muscle Invasive Bladder 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/NCT05996952
  org study id: 2023(24)
  nct id: NCT05996952
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This study will evaluate the efficacy and safety of intravenous RC48-ADC in adjuvant/salvage
        treatment of HER2 positive high-risk non-muscle-invasive bladder cancer.
  This study is a multicenter phase II study, which aims to evaluate the efficacy and safety of
        intravenous RC48-ADC in adjuvant/salvage treatment of HER2 positive high-risk
        non-muscle-invasive bladder cancer.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: 12-month recurence-free survival rate
  time frame: From treatment initiation to 12 month
  description: The probability of patients remaining free of high-risk NMIBC or worse for at least 12 months after first dose of RC48-ADC adjuvant treatment
  measure: 3-month pathological complete response rate
  time frame: From treatment initiation to 3 month
  description: The proportion of patients are negative for urine cytology and cystoscopy at 3 month after first dose of RC48-ADC salvage treatment
  measure: Adverse events
  time frame: From patient screening to 30 days after end of cycle 6
  description: The type, incidence, relatedness, and severity of adverse events
  measure: 6-month recurence-free survival rate
  time frame: From treatment initiation to 6 month
  description: The probability of patients remaining free of high-risk NMIBC or worse for at least 6 months after first dose of RC48-ADC adjuvant treatment
  measure: Duration of response
  time frame: From time of complete response to up to 60 months
  description: Time from complete response to recurrence of any disease
  measure: Recurrence-free survival
  time frame: From time of first dose of RC48-ADC adjuvant treatment to up to 60 months
  description: Time from first dose of RC48-ADC adjuvant treatment to high-risk NMIBC recurrence or worse
  measure: Progression-free survival
  time frame: From time of first dose of RC48-ADC treatment to up to 60 months
  description: Time from first dose of RC48-ADC treatment to progression to higher stage or death
  measure: Overall survival
  time frame: From time of first dose of RC48-ADC treatment to up to 60 months
  description: Time from first dose of RC48-ADC treatment to death from any cause
  measure: Quality of life assessed by EQ-5D scale
  time frame: After every cycle of treatment and 30 days after end of cycle 6
  description: Assessed by eEuroQoL EQ-5D scale, higher scores mean better outcomes
  arm group label: Adjuvant RC48-ADC
  arm group type: Experimental
  description: In this arm, RC48-ADC is evaluated in patients with HER2-positive high-risk non-muscle-invasive bladder cancer as an adjuvant treatment.
  arm group label: Salvage RC48-ADC
  arm group type: Experimental
  description: In this arm, RC48-ADC is evaluated in patients with HER2-positive non-muscle-invasive bladder cancer who failed BCG treatment as an adjuvant treatment.
  intervention type: Drug
  intervention name: RC48-ADC
  description: Patients are treated with RC48-ADC at 2.0 mg/kg as an intravenous infusion over 30-90 minutes (60 minutes is recommended) once every 2 weeks for 12 weeks.
  arm group label: Adjuvant RC48-ADC
  arm group label: Salvage RC48-ADC
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Hao Zeng
  role: Principal Investigator
  affiliation: West China Hospital
  last name: Hao Zeng
  phone: 8602885422114
  email: kucaizeng@163.com
  last name: Junru Chen
  phone: 8602885422114
  email: jrchen@scu.edu.cn
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: West China Hospital
  investigator full name: Hao Zeng
  investigator title: Professor
  mesh term: Urinary Bladder Neoplasms
  mesh term: Non-Muscle Invasive Bladder Neoplasms
  sharing ipd: No