<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/NCT04452591</url>
  </required_header>
  <id_info>
    <org_study_id>CG3002S</org_study_id>
    <nct_id>NCT04452591</nct_id>
  </id_info>
  <brief_title>Study of CG0070 Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin</brief_title>
  <acronym>BOND-003</acronym>
  <official_title>A Phase 3 Study of CG0070 in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus-Calmette-Guerin (BCG)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CG Oncology, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CG Oncology, Inc.</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>
      To evaluate the activity of intravesical (IVE) administration of CG0070 in patients with&#xD;
      tissue pathology confirmed non-muscular invasive bladder cancer (NMIBC) who have&#xD;
      Bacillus-Calmette-Guerin (BCG) unresponsive disease, with either carcinoma in situ with or&#xD;
      without Ta/T1 disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An open-label trial designed to evaluate CG0070 + DDM in patients with NMIBC who have failed&#xD;
      prior BCG therapy. Single treatment arm that will enroll up to 110 patients with carcinoma in&#xD;
      situ with or without concomitant high-grade Ta or T1 papillary disease&#xD;
&#xD;
      BCG failure is defined as a persistent or recurrent disease within 12 months of completion of&#xD;
      adequate BCG therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 27, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2024</primary_completion_date>
  <phase>Phase 3</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>Complete response rate in patients with carcinoma in situ (with or without concomitant high-grade Ta or T1 papillary disease)</measure>
    <time_frame>24 months</time_frame>
    <description>Percentage of patients with a complete response as defined by FDA guidance document dated February 2018 for NMIBC.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Median Duration of response (DOR)</measure>
    <time_frame>24 months</time_frame>
    <description>Median duration of response in patients with a CR or PR in subjects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median progression free survival</measure>
    <time_frame>24 months</time_frame>
    <description>Median duration of progression free survival of subjects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to tumor progression (TTP)</measure>
    <time_frame>24 months</time_frame>
    <description>Median time until patient disease progression (PD) in subjects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events when CG0070 administered alone.</measure>
    <time_frame>24 months</time_frame>
    <description>Percentage of patients with adverse events by grade as determined by NCI CTCAE v5.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of complete response in patients with persistent disease versus relapsed disease at baseline.</measure>
    <time_frame>24 months</time_frame>
    <description>Percentage in CR</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Non Muscular Invasive Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>Single Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease.&#xD;
CG0070 will be administered intravesically (IVE) following a sequence of bladder washes with 5% DDM and normal saline. CG0070 will be administered weekly x 6 on Weeks 1, 2, 3, 4, 5, and 6. If the patient has persistent high-grade disease at Week 13, the patient will receive another cycle of 6 weekly treatments. If there is no disease present at Week 13 (e.g. complete response) then the patient will receive 3 weekly treatments.&#xD;
Beginning at Week 25, patients will receive weekly x 3 treatments every 12 weeks through week 49then every 24 weeks thereafter.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CG0070</intervention_name>
    <description>Engineered Oncolytic Adenovirus</description>
    <arm_group_label>Single Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>n-dodecyl-B-D-maltoside</intervention_name>
    <description>Transduction-enhancing agent.</description>
    <arm_group_label>Single Arm</arm_group_label>
    <other_name>DDM</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2&#xD;
&#xD;
          -  Have pathologically confirmed World Health Organization (WHO) grading system employed&#xD;
             for tumor grading) high-risk NMIBC unresponsive to prior BCG therapy defined as:&#xD;
&#xD;
        Persistent or recurrent CIS alone or with recurrent Ta/T1 (noninvasive papillary&#xD;
        disease/tumor invades the subepithelial connective tissue) disease within 12 months of&#xD;
        completion of adequate BCG therapy&#xD;
&#xD;
          -  Received prior adequate BCG therapy as defined as at least one of the following (&quot;5+2&quot;&#xD;
             minimum exposure):&#xD;
&#xD;
               1. At least five of six doses of an initial induction course (adequate induction)&#xD;
                  plus at least two of three doses of maintenance therapy, OR&#xD;
&#xD;
               2. At least five of six doses of an initial induction course (adequate induction)&#xD;
                  plus at least two of six doses of a second induction course.&#xD;
&#xD;
          -  Ineligible for radical cystectomy or refusal of radical cystectomy&#xD;
&#xD;
          -  Adequate organ function&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic&#xD;
             bladder cancer&#xD;
&#xD;
          -  Has known upper tract or prostatic urethra malignancy&#xD;
&#xD;
          -  Has systemic anti-cancer therapy, including investigational agents, within 4 weeks of&#xD;
             Baseline&#xD;
&#xD;
          -  Immuno-deficient due to chronic steroid or other immunosuppressant use, HIV, or prior&#xD;
             organ transplant&#xD;
&#xD;
          -  Prior treatment with adenovirus-based cancer therapy&#xD;
&#xD;
          -  Clinically significant or active cardiac disease&#xD;
&#xD;
          -  Active autoimmune disease&#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>James Burke, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CG Oncology, Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>JoAnn Horn</last_name>
    <phone>516-456-1415</phone>
    <email>joann.horn@CGoncology.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Urology Centers of Alabama</name>
      <address>
        <city>Homewood</city>
        <state>Alabama</state>
        <zip>35209</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>BCG Oncology</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Cancer Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clinical Trials Office All Mayo Clinic Locations</last_name>
      <phone>855-776-0015</phone>
    </contact>
    <investigator>
      <last_name>Mark Tyson, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Arizona Institute of Urology</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85704</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Crystal Palencia</last_name>
    </contact>
    <investigator>
      <last_name>Jay Page, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of California - Irvine</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Steven Bereta</last_name>
    </contact>
    <investigator>
      <last_name>Edward Uchio, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>American Institute of Research</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90017</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Skyline Urology - Sherman Oaks</name>
      <address>
        <city>Sherman Oaks</city>
        <state>California</state>
        <zip>91411</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Skyline Urology - Torrance</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Janet Kukreja</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>MedStar Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lambros Stamatakis</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic - Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrew Hendrix</last_name>
    </contact>
    <investigator>
      <last_name>Timothy Lyon, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Moffit Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rodger Li</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Misaki Mason</last_name>
    </contact>
    <investigator>
      <last_name>Shreyas Joshi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Kansas</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Eugene Lee, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chesapeake Urology</name>
      <address>
        <city>Severna Park</city>
        <state>Maryland</state>
        <zip>21076</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rian Dickstein</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Mayo Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paras Shah</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Mercy Medical Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gautam Agarwal</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>New Jersey Urology</name>
      <address>
        <city>Edison</city>
        <state>New Jersey</state>
        <zip>08837</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Haleema Hameed</last_name>
    </contact>
    <investigator>
      <last_name>Joshua Wein, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Our Lady of Lourdes</name>
      <address>
        <city>Binghamton</city>
        <state>New York</state>
        <zip>13905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kathleen McGinley</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>StonyBrook Cancer Center</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794-263</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Audrey Anderson</last_name>
    </contact>
    <investigator>
      <last_name>David Golumbos, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Whitney Franz</last_name>
    </contact>
    <investigator>
      <last_name>Brant Inman, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Wake Forest University</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matvey Tsivian</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Toledo</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43614</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephanie Smiddy</last_name>
    </contact>
    <investigator>
      <last_name>Firas G Petros, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania, Perelman School of Medicine</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hanna Stambakio</last_name>
    </contact>
    <investigator>
      <last_name>Thomas Guzzo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Prisma Health</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29615</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Leesa Judd</last_name>
    </contact>
    <investigator>
      <last_name>Ryan Werntz, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Carolina Urologic Research Center</name>
      <address>
        <city>Myrtle Beach</city>
        <state>South Carolina</state>
        <zip>29572</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ryan Sutton</last_name>
    </contact>
    <investigator>
      <last_name>Neal Shore, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pamela Steele</last_name>
    </contact>
    <investigator>
      <last_name>Sam Chang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Baylor Scott and White</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Urology San Antonio, PA</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Spokane Urology</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Barwon Health, University Hospital Geelong</name>
      <address>
        <city>Geelong</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Royal Melbourne Hospital</name>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Wollongong Private Hospital</name>
      <address>
        <city>Wollongong</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital East</name>
      <address>
        <city>Chiba</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nagoya University Hospital</name>
      <address>
        <city>Fujita</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hirosaki University Hospital</name>
      <address>
        <city>Hashimoto</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chugoku Rosai Hospital</name>
      <address>
        <city>Hiroshima</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Shinshu University Hospital</name>
      <address>
        <city>Ishizuka</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Tsukuba Hospital</name>
      <address>
        <city>Kandori</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nara Medical University Hospital</name>
      <address>
        <city>Kashihara</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Jikei University Kashiwa Hospital</name>
      <address>
        <city>Kashiwa</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>St. Marianna University Hospital</name>
      <address>
        <city>Kikuchi</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kyoto Medical Center</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kagawa Rosai Hospital</name>
      <address>
        <city>Marugame</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Keio University Hospital</name>
      <address>
        <city>Matsumoto</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Okayama University Hospital</name>
      <address>
        <city>Okayama</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Osaka City University Hospital</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Osaka Medical and Pharmaceutical University Hospital</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kitsato University Hospital</name>
      <address>
        <city>Sagamihara</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Saitama City Hospital</name>
      <address>
        <city>Saitama</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sapporo Medical University Hospital</name>
      <address>
        <city>Sapporo</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Shizuoka General Hospital</name>
      <address>
        <city>Shizuoka</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Keio University Hospital</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ehime University Hospital</name>
      <address>
        <city>Toon</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Toyoma University Hospital</name>
      <address>
        <city>Toyoma</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Wakayama Medical University Hospital</name>
      <address>
        <city>Wakayama</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Yokohama Medical Center</name>
      <address>
        <city>Yokohama</city>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Pusan National University Hospital</name>
      <address>
        <city>Busan</city>
        <zip>49241</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Cancer Center</name>
      <address>
        <city>Goyang-si</city>
        <zip>10408</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Pusan National University Yangsan Hospital</name>
      <address>
        <city>Gyeongsang</city>
        <zip>50612</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chonnam National University Hwasun Hospital</name>
      <address>
        <city>Jeongnam</city>
        <zip>58128</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Korea University Anam Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Keelung Chang Gung Memorial Hospital</name>
      <address>
        <city>Keelung City</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Keelung Chang Gung Memorial Hospital</name>
      <address>
        <city>Keelung</city>
        <zip>204</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Taiwan</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>May 10, 2023</last_update_submitted>
  <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>high-grade Ta papillary disease</keyword>
  <keyword>high-grade T1 papillary disease</keyword>
  <keyword>carcinoma in situ</keyword>
  <keyword>Bacillus-Calmette-Guerin unresponsive</keyword>
  <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>


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/NCT04452591
org study id: CG3002S
nct id: NCT04452591
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
To evaluate the activity of intravesical (IVE) administration of CG0070 in patients with
      tissue pathology confirmed non-muscular invasive bladder cancer (NMIBC) who have
      Bacillus-Calmette-Guerin (BCG) unresponsive disease, with either carcinoma in situ with or
      without Ta/T1 disease
An open-label trial designed to evaluate CG0070 + DDM in patients with NMIBC who have failed
      prior BCG therapy. Single treatment arm that will enroll up to 110 patients with carcinoma in
      situ with or without concomitant high-grade Ta or T1 papillary disease

      BCG failure is defined as a persistent or recurrent disease within 12 months of completion of
      adequate BCG therapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Complete response rate in patients with carcinoma in situ (with or without concomitant high-grade Ta or T1 papillary disease)
time frame: 24 months
description: Percentage of patients with a complete response as defined by FDA guidance document dated February 2018 for NMIBC.
measure: Median Duration of response (DOR)
time frame: 24 months
description: Median duration of response in patients with a CR or PR in subjects
measure: Median progression free survival
time frame: 24 months
description: Median duration of progression free survival of subjects
measure: Time to tumor progression (TTP)
time frame: 24 months
description: Median time until patient disease progression (PD) in subjects
measure: Incidence of adverse events when CG0070 administered alone.
time frame: 24 months
description: Percentage of patients with adverse events by grade as determined by NCI CTCAE v5.0.
measure: Comparison of complete response in patients with persistent disease versus relapsed disease at baseline.
time frame: 24 months
description: Percentage in CR
arm group label: Single Arm
arm group type: Experimental
description: Patients with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease.
CG0070 will be administered intravesically (IVE) following a sequence of bladder washes with 5% DDM and normal saline. CG0070 will be administered weekly x 6 on Weeks 1, 2, 3, 4, 5, and 6. If the patient has persistent high-grade disease at Week 13, the patient will receive another cycle of 6 weekly treatments. If there is no disease present at Week 13 (e.g. complete response) then the patient will receive 3 weekly treatments.
Beginning at Week 25, patients will receive weekly x 3 treatments every 12 weeks through week 49then every 24 weeks thereafter.
intervention type: Biological
intervention name: CG0070
description: Engineered Oncolytic Adenovirus
arm group label: Single Arm
intervention type: Other
intervention name: n-dodecyl-B-D-maltoside
description: Transduction-enhancing agent.
arm group label: Single Arm
other name: DDM
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: James Burke, MD
role: Principal Investigator
affiliation: CG Oncology, Inc.
last name: JoAnn Horn
phone: 516-456-1415
email: joann.horn@CGoncology.com
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
country: Australia
country: Japan
country: Korea, Republic of
country: Taiwan
country: United States
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms
mesh term: Non-Muscle Invasive Bladder Neoplasms
sharing ipd: No