<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/NCT04427774</url>
  </required_header>
  <id_info>
    <org_study_id>CIBI391A101</org_study_id>
    <nct_id>NCT04427774</nct_id>
  </id_info>
  <brief_title>A Study of Surufatinib Plus Sintilimab in Patients With Advanced Solid Tumor</brief_title>
  <official_title>A Phase Ib Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Surufatinib Plus Sintilimab in Patients With Advanced Solid Tumor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Innovent Biologics (Suzhou) Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Innovent Biologics (Suzhou) 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>
      The purpose of this study is to evaluate the safety and efficacy of Surufatinib plus&#xD;
      Sintilimab in Patients with Advanced Solid Tumor&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Policy change, not for security reasons&#xD;
  </why_stopped>
  <start_date type="Actual">June 29, 2020</start_date>
  <completion_date type="Actual">April 27, 2021</completion_date>
  <primary_completion_date type="Actual">February 8, 2021</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>Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs)</measure>
    <time_frame>Baseline through 30 days after end of treatment, up to approximately 24months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall response rate in subjects with measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1</measure>
    <time_frame>Baseline and every 6 weeks through week 48, and then every 12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Advanced or Metastatic Solid Tumors</condition>
  <arm_group>
    <arm_group_label>Surufatinib plus Sintilimab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Surufatinib plus Sintilimab</intervention_name>
    <description>Surufatinib will be given orally. Sintilimab will be given intravenously</description>
    <arm_group_label>Surufatinib plus Sintilimab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Advanced or metastatic and recurrent cancer where an appropriate treatment option is&#xD;
             not available&#xD;
&#xD;
          2. Have measurable disease based on RECIST 1.1&#xD;
&#xD;
          3. Life expectancy &gt; 12 weeks&#xD;
&#xD;
          4. Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any therapy with anti-PD-1, or anti-PD-L1/l2 antibodies or anti-cytotoxic T lymphocyte&#xD;
             associated antigen-4 (CTLA-4) antibody (or any other antibody acting on T cell&#xD;
             costimulatory or checkpoint pathway) or fruquintinib treatment in previous;&#xD;
&#xD;
          2. Prior receipt of Surufatinib&#xD;
&#xD;
          3. History of any active autoimmune disease or autoimmune disease, including but not&#xD;
             limited to interstitial pneumonia, uveitis, inflammatory bowel disease, hepatitis,&#xD;
             pituitary inflammation, vasculitis, systemic lupus erythematosus, etc. (except&#xD;
             patients with hypothyroidism that can be controlled only by hormone replacement&#xD;
             therapy and patients with type I diabetes who only need insulin replacement therapy)&#xD;
&#xD;
          4. History of gastrointestinal perforation and/or fistula, ileus, inflammatory bowel&#xD;
             disease, or extensive enterotomy (partial colectomy or extensive enterotomy with&#xD;
             chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea within 6&#xD;
             months prior to first dosing&#xD;
&#xD;
          5. Any life-threatening bleeding event or grade 3 or 4 bleeding requiring blood&#xD;
             transfusion, endoscopy, or surgery with 3 months prior to dosing.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jiangsu Province</name>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>July 19, 2021</last_update_submitted>
  <last_update_submitted_qc>July 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2021</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/NCT04427774
org study id: CIBI391A101
nct id: NCT04427774
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the safety and efficacy of Surufatinib plus
      Sintilimab in Patients with Advanced Solid Tumor
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs)
time frame: Baseline through 30 days after end of treatment, up to approximately 24months
measure: Overall response rate in subjects with measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
time frame: Baseline and every 6 weeks through week 48, and then every 12 weeks
arm group label: Surufatinib plus Sintilimab
arm group type: Experimental
intervention type: Drug
intervention name: Surufatinib plus Sintilimab
description: Surufatinib will be given orally. Sintilimab will be given intravenously
arm group label: Surufatinib plus Sintilimab
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Neoplasms