<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/NCT03774979</url>
  </required_header>
  <id_info>
    <org_study_id>SHR-1701-I-102</org_study_id>
    <nct_id>NCT03774979</nct_id>
  </id_info>
  <brief_title>SHR-1701 in Subjects With Metastatic or Locally Advanced Solid Tumors</brief_title>
  <official_title>A Phase I, Open-label Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of SHR-1701 in Subjects With Metastatic or Locally Advanced Solid Tumors With Expansion to Selected Indications</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu HengRui Medicine Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu HengRui Medicine 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 main purpose of this study is to assess the safety and tolerability of SHR-1701 at&#xD;
      different dose levels. Study consists of dose-escalation part and an expansion part in&#xD;
      subjects with metastatic or locally advanced solid tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase I, open-label, multiple-ascending dose trial. Study consists of&#xD;
      dose-escalation part in subjects with metastatic or locally advanced solid tumors, and&#xD;
      expansion part with selected indications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 24, 2019</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">March 2023</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>Dose escalation part： Safety and tolerability of SHR-1701 in advanced malignancies.</measure>
    <time_frame>Up to 3/4 weeks.</time_frame>
    <description>Number of Subjects who occurs dose-limiting toxicity (DLTs).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical expansion Part: Objective Response Rate（ORR）</measure>
    <time_frame>Up to 6 weeks</time_frame>
    <description>ORR is define as the percentage of participants in the analysis population who havea Complete Response(CR:Disappearance of all target lesions)or a Partial Response(PR :30% decrease in the sum of diameter of target lesions) per RECIST 1.1.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical expansion Part: Safety of SHR-1701</measure>
    <time_frame>Up to 4 weeks after last treatment</time_frame>
    <description>Number of subjects who occurs treatment-related Adverse Events(AEs）</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical expansion Part: Disease Control Rate(DCR) per RECIST1.1</measure>
    <time_frame>Up to 6 weeks</time_frame>
    <description>DCR is define as the percentage of participants in the analysis population who have a CR,PR or SD per RECIST 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical expansion Part: Duration of Response （DOR）per RECIST1.1</measure>
    <time_frame>Up to 6 weeks</time_frame>
    <description>DOR is define as the time from first documented evidence of CR or PR until disease progression per RECIST 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical expansion Part:Progression-free survival(PFS) per RECIST1.1</measure>
    <time_frame>12months (anticipated)</time_frame>
    <description>PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">193</enrollment>
  <condition>Solid Tumor</condition>
  <arm_group>
    <arm_group_label>SHR-1701</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intravenous infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SHR-1701</intervention_name>
    <description>Subjects will receive an intravenous infusion of SHR-1701 in a pre-set dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.</description>
    <arm_group_label>SHR-1701</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able and willing to provide signed informed consent form, and able to comply with all&#xD;
             procedures.&#xD;
&#xD;
          -  Histologically or cytologically proven metastatic or locally advanced solid tumors.&#xD;
&#xD;
          -  Male or female subjects aged 18-75 years.&#xD;
&#xD;
          -  Life expectancy &gt;= 12 weeks as judged by the Investigator.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry.&#xD;
&#xD;
          -  Disease must be measurable with at least 1 uni dimensional measurable lesion by&#xD;
             Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.&#xD;
&#xD;
          -  Adequate hematological, hepatic and renal function as defined in the protocol&#xD;
&#xD;
        Other protocol-defined inclusion criteria could apply.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior therapy with an anti-PD1, anti-PD-L1, anti-CTLA-4 or a TGFb inhibitor.&#xD;
&#xD;
          -  Anticancer treatment within 28 days before the first dose of study drug.&#xD;
&#xD;
          -  Major surgery within 28 days before start of trial treatment.&#xD;
&#xD;
          -  Systemic therapy with immunosuppressive agents within 7 days prior to the first dose&#xD;
             of study drug; or use any investigational drug within 28 days before the start of&#xD;
             trial treatment.&#xD;
&#xD;
          -  With any active autoimmune disease or history of autoimmune disease.&#xD;
&#xD;
          -  With active central nervous system (CNS) metastases causing clinical symptoms or&#xD;
             requiring therapeutic intervention.&#xD;
&#xD;
          -  Clinically significant cardiovascular and cerebrovascular diseases&#xD;
&#xD;
          -  History of immunodeficiency including seropositive for human immunodeficiency virus&#xD;
             (HIV), or other acquired or congenital immunedeficient disease, or any active systemic&#xD;
             viral infection requiring therapy.&#xD;
&#xD;
          -  Previous malignant disease (other than the target malignancy to be investigated in the&#xD;
             trial) within the last 2 years. Subjects with history of cervical carcinoma in situ,&#xD;
             superficial or non-invasive bladder cancer or basal cell or squamous cell cancer in&#xD;
             situ previously treated with curative intent are NOT excluded.&#xD;
&#xD;
          -  Receipt of any organ transplantation, including allogeneic stem-cell transplantation&#xD;
&#xD;
        Other protocol-defined exclusion criteria could apply&#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>Jifeng Feng, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jiangsu Cancer Institute &amp; Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anhui Chest Hospital-Departmen of Tumor Radiotherapy</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Guangzhou University of Chinese Medicine-Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangzhou</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xinxiang Central Hospital-Department of Respiratory Physicians</name>
      <address>
        <city>Xinxiang</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhengzhou University-Department of Medical Oncology</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Hospital of Hunan Province</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hunan Cancer Hospital-Gynecologic Oncology</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jangsu Cancer Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Rffiurted Hospital of Soochow University</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <zip>215006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital Of Nanchang University</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of China Medical University-Department of Oncology</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qilu Hospital of Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250012</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Chest Hospital,Capital Medical University-Integrated Department</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tumor Hospital of the Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ChongQing Cancer Hospital-gynecologic oncology</name>
      <address>
        <city>Chongqing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chongqing Cancer Hospital</name>
      <address>
        <city>Chongqing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>November 6, 2022</last_update_submitted>
  <last_update_submitted_qc>November 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SHR-1701</keyword>
  <keyword>Solid tumor</keyword>
  <keyword>Metastatic or locally advanced solid tumors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT03774979
org study id: SHR-1701-I-102
nct id: NCT03774979
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main purpose of this study is to assess the safety and tolerability of SHR-1701 at
      different dose levels. Study consists of dose-escalation part and an expansion part in
      subjects with metastatic or locally advanced solid tumors.
This is a Phase I, open-label, multiple-ascending dose trial. Study consists of
      dose-escalation part in subjects with metastatic or locally advanced solid tumors, and
      expansion part with selected indications.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Dose escalation part： Safety and tolerability of SHR-1701 in advanced malignancies.
time frame: Up to 3/4 weeks.
description: Number of Subjects who occurs dose-limiting toxicity (DLTs).
measure: Clinical expansion Part: Objective Response Rate（ORR）
time frame: Up to 6 weeks
description: ORR is define as the percentage of participants in the analysis population who havea Complete Response(CR:Disappearance of all target lesions)or a Partial Response(PR :30% decrease in the sum of diameter of target lesions) per RECIST 1.1.
measure: Clinical expansion Part: Safety of SHR-1701
time frame: Up to 4 weeks after last treatment
description: Number of subjects who occurs treatment-related Adverse Events(AEs）
measure: Clinical expansion Part: Disease Control Rate(DCR) per RECIST1.1
time frame: Up to 6 weeks
description: DCR is define as the percentage of participants in the analysis population who have a CR,PR or SD per RECIST 1.1.
measure: Clinical expansion Part: Duration of Response （DOR）per RECIST1.1
time frame: Up to 6 weeks
description: DOR is define as the time from first documented evidence of CR or PR until disease progression per RECIST 1.1
measure: Clinical expansion Part:Progression-free survival(PFS) per RECIST1.1
time frame: 12months (anticipated)
description: PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1
arm group label: SHR-1701
arm group type: Experimental
description: intravenous infusion
intervention type: Drug
intervention name: SHR-1701
description: Subjects will receive an intravenous infusion of SHR-1701 in a pre-set dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.
arm group label: SHR-1701
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jifeng Feng, MD
role: Principal Investigator
affiliation: Jiangsu Cancer Institute & Hospital
facility: 
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country: China
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: No