<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/NCT04492293</url>
  </required_header>
  <id_info>
    <org_study_id>ICP-CL-00302</org_study_id>
    <nct_id>NCT04492293</nct_id>
  </id_info>
  <brief_title>An Efficacy and Safety Study of ICP-192 in Subjects With Bladder Urothelial Cancer</brief_title>
  <official_title>A Phase 2, Multicenter, Single Arm, Open-lable Study of ICP-192 in Subjects With Surgically Unresectable or Metastatic Bladder Urothelial Cancer With FGFR Genetic Aberrations.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing InnoCare Pharma Tech Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing InnoCare Pharma Tech Co., Ltd.</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 is a phase 2, multicenter, single arm, open-lable study of ICP-192. The purpose of this&#xD;
      study is to evaluate efficacy of ICP-192 in subjects with surgically unresectable or&#xD;
      metastatic bladder urothelial cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      bladder urothelial cancer&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 27, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2024</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>ORR</measure>
    <time_frame>From the time of first dose until objective disease progression, an average of 6 months</time_frame>
    <description>Objective Response Rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DOR</measure>
    <time_frame>From the time of first dose until objective disease progression, an average of 6 months</time_frame>
    <description>Duration of response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DCR</measure>
    <time_frame>From the time of first dose until objective disease progression, an average of 6 months</time_frame>
    <description>Disease Control Rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFS</measure>
    <time_frame>From the time of first dose until objective disease progression, an average of 6 months</time_frame>
    <description>Progression Free Survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS</measure>
    <time_frame>From the time of first dose until objective disease progression, an average of 1 months</time_frame>
    <description>Overall survival</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">115</enrollment>
  <condition>Bladder Urothelial Cancer</condition>
  <arm_group>
    <arm_group_label>ICP-192</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ICP-192</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ICP-192</intervention_name>
    <description>ICP-192 is a white, round, uncoated table</description>
    <arm_group_label>ICP-192</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria：&#xD;
&#xD;
          1. Signed the ICF and Age ≥ 18 years old, either sex.&#xD;
&#xD;
          2. ECOG ≤ 1.&#xD;
&#xD;
          3. Life expectancy of at least 3 months.&#xD;
&#xD;
          4. Histologically confirmed unresectable or metastatic bladder urothelial cancinoma.&#xD;
&#xD;
          5. At least one measurable lesion as the target lesion at screening assessed according to&#xD;
             RECIST V1.1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior treatment with selective FGFR inhibitors or FGFR antibodies.&#xD;
&#xD;
          2. Any corneal or retinal abnormalities that may result in an increased risk of ocular&#xD;
             toxicity.&#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>Jun Guo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Cancer Hospital &amp; Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jun Guo</last_name>
    <phone>010-88196348</phone>
    <email>guoj307@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Anhui Medical University</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chaozhao Liang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100035</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zisong He</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The fifth Medical Center of People's Liberation Army General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100071</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lijun Chen</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jun Guo</last_name>
      <phone>010-88196348</phone>
      <email>guoj307@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Chongqing Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400016</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Weiyang He</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lanzhou University Second Hospital</name>
      <address>
        <city>Lanzhou</city>
        <state>Gansu</state>
        <zip>730030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Li Yang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Harbin Medical University Cancer Hospital</name>
      <address>
        <city>Ha'erbin</city>
        <state>Heilongjiang</state>
        <zip>150081</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hui Chen</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430022</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaoping Zhang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shaogang Wang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hunan Cancer Hospital</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Weiqing Han</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Suzhou University</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <zip>215006</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuhua Huang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Hospital of JiLin University</name>
      <address>
        <city>Jilin</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ziling Liu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Liaoning Cancer Hospital &amp; Institute</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110801</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bin Hu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shandong University Qilu Hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250012</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benkang Shi</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ruijin Hospital, Shanghai Jiao Tong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Danfeng Xu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>First Hospital of Shanxi Medical University</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>030001</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaoming Cao</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sichuan Cancer Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liao Hong</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University Cancer Institute &amp; Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xin Yao</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Tianjin Medical University</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300211</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hailong Hu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liping Xie</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shaoxing Zhu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhejiang Provincial People's Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejing</state>
        <zip>310014</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Haiying Dong</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>December 26, 2022</last_update_submitted>
  <last_update_submitted_qc>December 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04492293
org study id: ICP-CL-00302
nct id: NCT04492293
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a phase 2, multicenter, single arm, open-lable study of ICP-192. The purpose of this
      study is to evaluate efficacy of ICP-192 in subjects with surgically unresectable or
      metastatic bladder urothelial cancer.
bladder urothelial cancer
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: ORR
time frame: From the time of first dose until objective disease progression, an average of 6 months
description: Objective Response Rate
measure: DOR
time frame: From the time of first dose until objective disease progression, an average of 6 months
description: Duration of response
measure: DCR
time frame: From the time of first dose until objective disease progression, an average of 6 months
description: Disease Control Rate
measure: PFS
time frame: From the time of first dose until objective disease progression, an average of 6 months
description: Progression Free Survival
measure: OS
time frame: From the time of first dose until objective disease progression, an average of 1 months
description: Overall survival
arm group label: ICP-192
arm group type: Experimental
description: ICP-192
intervention type: Drug
intervention name: ICP-192
description: ICP-192 is a white, round, uncoated table
arm group label: ICP-192
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jun Guo
role: Principal Investigator
affiliation: Peking University Cancer Hospital & Institute
last name: Jun Guo
phone: 010-88196348
email: guoj307@126.com
facility: 
status: Recruiting
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country: China
responsible party type: Sponsor