<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/NCT03809767</url>
  </required_header>
  <id_info>
    <org_study_id>CS1003-102</org_study_id>
    <nct_id>NCT03809767</nct_id>
  </id_info>
  <brief_title>A Study of CS1003 in Subjects With Advanced Solid Tumors or Lymphomas</brief_title>
  <official_title>A Phase Ia/Ib, Open-Label, Multiple-Dose, Dose-Escalation and Expansion Study of the Anti-PD-1 Monoclonal Antibody CS1003 in Subjects With Advanced Solid Tumors or Lymphomas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CStone Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CStone Pharmaceuticals</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase Ia/Ib, open-label, multiple-dose, dose-escalation and expansion study to&#xD;
      evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS1003 in&#xD;
      subjects with advanced solid tumors or lymphoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 29, 2018</start_date>
  <completion_date type="Actual">June 13, 2022</completion_date>
  <primary_completion_date type="Actual">August 30, 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>Number of participants with adverse events</measure>
    <time_frame>from the day of first dose to 90 days after last dose of CS1003</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">107</enrollment>
  <condition>Solid Tumor</condition>
  <condition>Lymphoma</condition>
  <arm_group>
    <arm_group_label>CS1003 monoclonal antibody</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CS1003 monoclonal antibody</intervention_name>
    <description>CS1003 will be administered intravenously every 3 weeks.</description>
    <arm_group_label>CS1003 monoclonal antibody</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Willing to sign the informed consent.&#xD;
&#xD;
          2. Subjects must have histologically or cytologically confirmed advanced or metastatic&#xD;
             solid tumor or unresectable lymphoma and have progressed, are intolerant to, refuse to&#xD;
             accept or do not have access to standard therapy.&#xD;
&#xD;
          3. ECOG performance status of 0 or 1.&#xD;
&#xD;
          4. Subjects with evaluable but non-measurable lesion are eligible for Phase Ia. Subjects&#xD;
             must have at least one measurable lesion per RECIST Version 1.1 to be eligible for&#xD;
             Phase Ib.&#xD;
&#xD;
          5. Archived tumor tissue samples need to be collected, or subjects consent to undergo&#xD;
             pre-treatment biopsy if archived sample is not available.&#xD;
&#xD;
          6. Life expectancy ≥ 3 months.&#xD;
&#xD;
          7. Subject must have adequate organ function.&#xD;
&#xD;
          8. Use of effective contraception (males and females).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with known symptomatic or untreated brain metastasis or other CNS metastasis.&#xD;
&#xD;
          2. Subjects with active autoimmune diseases or history of autoimmune diseases.&#xD;
&#xD;
          3. Subjects who have to receive glucocorticoids (prednisone at &gt; 10 mg/day or equivalent)&#xD;
             or other immunosuppression within 14 days prior to the first dose of CS1003.&#xD;
&#xD;
          4. Subjects with other malignant tumor(s) in the past 2 years are not eligible for Phase&#xD;
             Ib&#xD;
&#xD;
          5. Subjects who have received any immune checkpoint treatment, including PD-1, PD-L1,&#xD;
             etc.&#xD;
&#xD;
          6. History of HIV infection.&#xD;
&#xD;
          7. Subjects with active Hepatitis B and C infection requiring therapy.&#xD;
&#xD;
          8. Subjects with active infection of tuberculosis.&#xD;
&#xD;
          9. History of organ transplantation.&#xD;
&#xD;
         10. Unresolved toxicities from prior anti-cancer therapy.&#xD;
&#xD;
         11. History of uncontrolled allergic asthma and serious hypersensitive reaction to&#xD;
             monoclonal antibodies.&#xD;
&#xD;
         12. Subjects with major cardiovascular diseases.&#xD;
&#xD;
         13. History of alcoholism or drugs abuse.&#xD;
&#xD;
         14. Any condition that, in the opinion of the investigator or sponsor, would jeopardize&#xD;
             compliance.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hunan Cancer Hospital</name>
      <address>
        <city>Changsha</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong Provincial People's Hospital</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harbin Medical University Cancer Hospital</name>
      <address>
        <city>Harbin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yunnan Cancer Hospital</name>
      <address>
        <city>Kunming</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Nanchang University</name>
      <address>
        <city>Nanchang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huashan Hospital Fudan University</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai East Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai pulmonary hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University Cancer Institute and Hospital</name>
      <address>
        <city>Tianjin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Cancer Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</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 30, 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>Lymphoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_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/NCT03809767
org study id: CS1003-102
nct id: NCT03809767
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a phase Ia/Ib, open-label, multiple-dose, dose-escalation and expansion study to
      evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS1003 in
      subjects with advanced solid tumors or lymphoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with adverse events
time frame: from the day of first dose to 90 days after last dose of CS1003
arm group label: CS1003 monoclonal antibody
arm group type: Experimental
intervention type: Drug
intervention name: CS1003 monoclonal antibody
description: CS1003 will be administered intravenously every 3 weeks.
arm group label: CS1003 monoclonal antibody
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
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country: China
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Antibodies
mesh term: Antibodies, Monoclonal