<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/NCT04472858</url>
  </required_header>
  <id_info>
    <org_study_id>CS1001/Donafenib-101</org_study_id>
    <nct_id>NCT04472858</nct_id>
  </id_info>
  <brief_title>A Study of CS1001 in Combination With Donafenib in Subjects With Advanced Solid Tumors</brief_title>
  <official_title>A Phase I, Multicenter,Open-label,Dose-Escalation and Expansion Study of CS1001 in Combination With Donafenib in Patients With Advanced Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Suzhou Zelgen Biopharmaceuticals Co.,Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CStone Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Suzhou Zelgen Biopharmaceuticals Co.,Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <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 safety, tolerability, pharmacokinetics and treatment effect of&#xD;
      CS1001 in combination with Donafenib in patients with advanced solid tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trail uses an open, multi-center study design, Contains two parts: a dose escalation&#xD;
      part and a dose expansion part.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 15, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>From the day of first dose to 21 days after last dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>To determine the dose limiting toxicity (DLT)</measure>
    <time_frame>In the dose escalation part, from the day of first dose to 21 days after last dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>To determine the maximum tolerated dose(MTD)</measure>
    <time_frame>In the dose escalation part, from the day of first dose to 21 days after last dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>To determine the recommended dose of phase II</measure>
    <time_frame>In the dose escalation part, from the day of first dose to 21 days after last dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Objective response rate as determined by the Invertigator using RECIST V1.1</measure>
    <time_frame>In the dose escalation part, from the day of first dose to 21 days after last dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anti-CS1001 antibody</measure>
    <time_frame>From the day of first dose to 21 days after last dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate (ORR)</measure>
    <time_frame>From the day of first dose to 21 days after last dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival(OS)</measure>
    <time_frame>From the day of first dose to 21 days after last dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival(PFS)</measure>
    <time_frame>From the day of first dose to 21 days after last dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of remission (DOR)</measure>
    <time_frame>From the day of first dose to 21 days after last dose</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Advanced Solid Tumor</condition>
  <arm_group>
    <arm_group_label>Cholangiocarcinoma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cholangiocarcinoma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Squamous cell carcinoma of the head and neck</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Squamous cell carcinoma of the head and neck（HNSCC）</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endometrial cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endometrial cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Donafenib</intervention_name>
    <description>dose escalation: Donafenib 100 mg QD/100 mg BID/200 mg BID (p.o.). dose expansion: Patients will be assigned to specific tumor types and treated at the recommended dose for dose escalation.The recommended dose for dose escalation will be determined by the dose escalation study.</description>
    <arm_group_label>Cholangiocarcinoma</arm_group_label>
    <arm_group_label>Endometrial cancer</arm_group_label>
    <arm_group_label>Squamous cell carcinoma of the head and neck</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CS1001</intervention_name>
    <description>CS1001 will be administrated by intravenous (i.v.) infusion once every 28 days</description>
    <arm_group_label>Cholangiocarcinoma</arm_group_label>
    <arm_group_label>Endometrial cancer</arm_group_label>
    <arm_group_label>Squamous cell carcinoma of the head and neck</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fully understand this study and voluntarily sign ICF;&#xD;
&#xD;
          -  18 to 75 years old (including 18 and 75 years old), male or female;&#xD;
&#xD;
          -  Subjects with advanced solid tumors, including:&#xD;
&#xD;
        Phase I study:&#xD;
&#xD;
        subjects with advanced solid tumors confirmed by histology or cytology that are not&#xD;
        suitable for surgical resection, or have failed or tolerated standard treatment, or have no&#xD;
        standard treatment. Including but not limited to Cholangiocarcinoma , head and neck&#xD;
        squamous cell carcinoma (HNSCC) and endometrial cancer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any history of active autoimmune diseases or autoimmune diseases; patients with&#xD;
             vitiligo or asthma that has been completely relieved in childhood, and patients who do&#xD;
             not need any intervention after adulthood can be included;&#xD;
&#xD;
          -  Participants with any condition that impairs their ability to take oral medication,&#xD;
             such as lack of physical integrity of the upper gastrointestinal tract or&#xD;
             malabsorption syndrome.&#xD;
&#xD;
          -  Patients with uncontrolled pleural effusion, pericardial effusion, or ascites&#xD;
             requiring repeated drainage and need to retain a catheter;&#xD;
&#xD;
          -  Human immunodeficiency virus (HIV) antibody positive;&#xD;
&#xD;
          -  Patients who are simultaneously infected with hepatitis B virus and hepatitis C virus;&#xD;
&#xD;
          -  Lactating women. If they are willing to stop breastfeeding, they can also be included&#xD;
             in this study.&#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>Ye Guo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai East Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ye Guo, MD</last_name>
    <phone>13501678472</phone>
    <email>pattrickguo@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shanghai Eastern Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yan Guo, MD</last_name>
      <phone>13501678472</phone>
      <email>pattrickguo@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>November 28, 2022</last_update_submitted>
  <last_update_submitted_qc>November 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>


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/NCT04472858
org study id: CS1001/Donafenib-101
nct id: NCT04472858
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will evaluate the safety, tolerability, pharmacokinetics and treatment effect of
      CS1001 in combination with Donafenib in patients with advanced solid tumors.
This trail uses an open, multi-center study design, Contains two parts: a dose escalation
      part and a dose expansion part.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with adverse events
time frame: From the day of first dose to 21 days after last dose
measure: To determine the dose limiting toxicity (DLT)
time frame: In the dose escalation part, from the day of first dose to 21 days after last dose
measure: To determine the maximum tolerated dose(MTD)
time frame: In the dose escalation part, from the day of first dose to 21 days after last dose
measure: To determine the recommended dose of phase II
time frame: In the dose escalation part, from the day of first dose to 21 days after last dose
measure: Objective response rate as determined by the Invertigator using RECIST V1.1
time frame: In the dose escalation part, from the day of first dose to 21 days after last dose
measure: Anti-CS1001 antibody
time frame: From the day of first dose to 21 days after last dose
measure: Objective response rate (ORR)
time frame: From the day of first dose to 21 days after last dose
measure: Overall survival(OS)
time frame: From the day of first dose to 21 days after last dose
measure: Progression free survival(PFS)
time frame: From the day of first dose to 21 days after last dose
measure: Duration of remission (DOR)
time frame: From the day of first dose to 21 days after last dose
arm group label: Cholangiocarcinoma
arm group type: Experimental
description: Cholangiocarcinoma
arm group label: Squamous cell carcinoma of the head and neck
arm group type: Experimental
description: Squamous cell carcinoma of the head and neck（HNSCC）
arm group label: Endometrial cancer
arm group type: Experimental
description: Endometrial cancer
intervention type: Drug
intervention name: Donafenib
description: dose escalation: Donafenib 100 mg QD/100 mg BID/200 mg BID (p.o.). dose expansion: Patients will be assigned to specific tumor types and treated at the recommended dose for dose escalation.The recommended dose for dose escalation will be determined by the dose escalation study.
arm group label: Cholangiocarcinoma
arm group label: Endometrial cancer
arm group label: Squamous cell carcinoma of the head and neck
intervention type: Drug
intervention name: CS1001
description: CS1001 will be administrated by intravenous (i.v.) infusion once every 28 days
arm group label: Cholangiocarcinoma
arm group label: Endometrial cancer
arm group label: Squamous cell carcinoma of the head and neck
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ye Guo, MD
role: Principal Investigator
affiliation: Shanghai East Hospital
last name: Ye Guo, MD
phone: 13501678472
email: pattrickguo@gmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Neoplasms