<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/NCT03821363</url>
  </required_header>
  <id_info>
    <org_study_id>SCT-I10A-X101</org_study_id>
    <nct_id>NCT03821363</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability, Pharmacokinetics and Efficacy of SCT-I10A in Patients With Advanced Solid Tumors or Lymphoma</brief_title>
  <official_title>Recombinant Humanized Anti- PD-1 Monoclonal Antibody（SCT-I10A） in Patients With Advanced Solid Tumors or Lymphoma :a Phase Ⅰ, Open-label, Multicenter Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sinocelltech Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sinocelltech 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, tolerability, pharmacokinetics and&#xD;
      preliminary efficacy of recombinant humanized anti- PD-1 monoclonal antibody（SCT-I10A）in&#xD;
      patients with advanced solid tumors or lymphoma treated after failure of standard therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This open label, multicenter phase I study is designed to evaluate the safety, tolerability,&#xD;
      pharmacokinetics and preliminary efficacy in advanced solid tumors or lymphoma treated with&#xD;
      anti- PD-1 monoclonal antibody SCT-I10A. The trial will be divided into two parts:&#xD;
      dose-exploration and indication expansion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 13, 2018</start_date>
  <completion_date type="Anticipated">July 2020</completion_date>
  <primary_completion_date type="Anticipated">July 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety/Tolerability</measure>
    <time_frame>24 months</time_frame>
    <description>Incidence of adverse events and outlier of laboratory tests, positive rate of immunogenicity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective response rate (ORR)</measure>
    <time_frame>24 months</time_frame>
    <description>ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 or Lugano 2014 criteria during trial treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DOR)</measure>
    <time_frame>24 months</time_frame>
    <description>DOR is defined as time from the date when a patient first meets the criteria for CR or PR according to RECIST v1.1 or Lugano 2014 criteria, until the date that progressive disease (PD) is objectively documented or death, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate (DCR)</measure>
    <time_frame>24 months</time_frame>
    <description>PFS is defined as the time from first dose of SCT200 until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 or Lugano 2014 criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (PFS)</measure>
    <time_frame>24 months</time_frame>
    <description>PFS is defined as the time from first dose of SCT200 until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 or Lugano 2014 criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>24 months</time_frame>
    <description>OS is defined as time from first dose of SCT200 until the date of death from any cause.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">206</enrollment>
  <condition>Advanced Solid Tumors or Lymphoma</condition>
  <arm_group>
    <arm_group_label>Low dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SCT-I10A will be administered at a dose of 60mg, Q3W up to 24 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Middle dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SCT-I10A will be administered at a dose of 200mg, Q3W up to 24 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SCT-I10A will be administered at a dose of 600mg, Q3W up to 24 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>SCT-I10A</intervention_name>
    <description>Experimental: Anti- PD-1 monoclonal antibody（SCT-I10A）</description>
    <arm_group_label>High dose group</arm_group_label>
    <arm_group_label>Low dose group</arm_group_label>
    <arm_group_label>Middle dose group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to provide written informed consent before screening；&#xD;
&#xD;
          -  Males or females. Aged 18 to 75 years old;&#xD;
&#xD;
          -  Life expectancy≥12 weeks before starting treatment (clinical assessment);&#xD;
&#xD;
          -  With an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;&#xD;
&#xD;
          -  Histologically or cytologically confirmed advanced solid tumor or lymphoma;&#xD;
&#xD;
          -  Advanced solid tumor or lymphoma with standard treatment failed or no effective&#xD;
             therapy;&#xD;
&#xD;
          -  According to RECIST 1.1 or Lugano 2014 criteria, patients must have at least one&#xD;
             measurable lesion that can be accurately assessed;&#xD;
&#xD;
          -  Adequate organ and bone marrow function as defined below:&#xD;
&#xD;
        Absolute neutrophil count (ANC) greater than/equal to 1.5×l09/L; Platelets greater&#xD;
        than/equal to 75×109/L; Hemoglobin greater than/equal to 80g/L; Aspartate aminotransferase&#xD;
        (AST)/alanine aminotransferase (ALT) less than/equal to 2.5 times ULN, or less than/equal&#xD;
        to 5 times ULN if known liver metastases; Total bilirubin less than/equal to 1.5 times ULN;&#xD;
        Serum creatinine less than/equal to 1.5 times ULN or Ccr&gt;50ml/min; Thyroid stimulating&#xD;
        hormone (TSH) hormone levels less than/equal to ULN.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are allergic to analogue of SCT-I10A and/or its inactive ingredients;&#xD;
&#xD;
          -  Patients have been treated with anti-PD-L1 and anti-PD-1 antibody;&#xD;
&#xD;
          -  Patients are currently enrolled in other research devices or in research drugs, or&#xD;
             less than 4 weeks from other research drugs or devices;&#xD;
&#xD;
          -  Within 4 weeks prior to the first dose of study drug, patients have received&#xD;
             anti-tumor drugs (such as chemotherapy, endocrine therapy, targeted therapy, immune&#xD;
             therapy, tumor embolization). Within 6 weeks prior to the first dose of study drug,&#xD;
             patients have been treated with biological products, nitrosourea or mitomycin C;&#xD;
&#xD;
          -  Within 2 weeks prior to the first dose of study drug, patients have received&#xD;
             corticosteroids or other immunosuppressive agents;&#xD;
&#xD;
          -  Within 4 weeks prior to the first dose of study drug, patients have received live&#xD;
             attenuated vaccine (LAV), or who planned to use LAV during the study period;&#xD;
&#xD;
          -  Within 4 weeks prior to the first dose of study drug, patients have received major&#xD;
             surgery, or had wounds, ulcers or fractures that haven't healed;&#xD;
&#xD;
          -  Prior to the first dose of study drug, patients had toxicity due to previous&#xD;
             anti-tumor treatment, which hasn't return to Grade 0-1 according to the NCI&#xD;
             CTCAEv4.03;&#xD;
&#xD;
          -  Patient with cerebrospinal meningitis metastasis or central nervous system metastasis&#xD;
             with untreated or uncontrolled with other treatment;&#xD;
&#xD;
          -  Patients with an active, known or suspected autoimmune disease or a history of&#xD;
             autoimmune disease;&#xD;
&#xD;
          -  Patients with a history of allogeneic organ transplantation or allogeneic&#xD;
             hematopoietic stem cell transplantation;&#xD;
&#xD;
          -  Within 6 months prior to study, patients had uncontrolled concurrent diseases,&#xD;
             including but not limited to acute myocardial infarction, unstable angina pectoris,&#xD;
             stroke, or transient ischemic attack, congestive heart failure (NYHA, greater than&#xD;
             II), left ventricular ejection fraction (LVEF) &lt;50%, and with related heart disease.&#xD;
             Patients with chronic or acute disease, psychological or psychiatric disorders,&#xD;
             laboratory abnormalities which may affect subject compliance and outcomes in this&#xD;
             clinical study;&#xD;
&#xD;
          -  Patients with HIV, active hepatitis B (HBV DNA≥104 copies/ml) or active hepatitis C&#xD;
             (HCV RNA≥103 copies/ml), etc.;&#xD;
&#xD;
          -  Patients who have interstitial lung disease, such as interstitial pneumonia, pulmonary&#xD;
             fibrosis, or CT or MRI reminder ILD.&#xD;
&#xD;
          -  Patients with clinical symptoms, required clinical intervention or stable time less&#xD;
             than 4 weeks of serous cavity effusion (such as pleural effusion and ascites);&#xD;
&#xD;
          -  Patients with other primary malignancies;&#xD;
&#xD;
          -  Pregnant or lactating women;&#xD;
&#xD;
          -  Patients who were not willing to accept effective contraceptive measures during&#xD;
             treatment and within 6 months after treatment;&#xD;
&#xD;
          -  Subjects who are considered not suitable for the study by investigator.&#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_contact>
    <last_name>jianming xu, MD</last_name>
    <phone>+8613910866712</phone>
    <email>jmxu2003@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Fifth Medical Center of PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100071</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>jianming xu, MD</last_name>
      <phone>+8613910866712</phone>
      <email>jmxu2003@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neoplasms</keyword>
  <keyword>Solid Tumors</keyword>
  <keyword>Lymphoma</keyword>
  <keyword>PD-1</keyword>
  <keyword>SCT-I10A</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</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/NCT03821363
org study id: SCT-I10A-X101
nct id: NCT03821363
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, tolerability, pharmacokinetics and
      preliminary efficacy of recombinant humanized anti- PD-1 monoclonal antibody（SCT-I10A）in
      patients with advanced solid tumors or lymphoma treated after failure of standard therapy.
This open label, multicenter phase I study is designed to evaluate the safety, tolerability,
      pharmacokinetics and preliminary efficacy in advanced solid tumors or lymphoma treated with
      anti- PD-1 monoclonal antibody SCT-I10A. The trial will be divided into two parts:
      dose-exploration and indication expansion.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies
primary purpose: Treatment
masking: None (Open Label)
measure: Safety/Tolerability
time frame: 24 months
description: Incidence of adverse events and outlier of laboratory tests, positive rate of immunogenicity
measure: Objective response rate (ORR)
time frame: 24 months
description: ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 or Lugano 2014 criteria during trial treatment.
measure: Duration of response (DOR)
time frame: 24 months
description: DOR is defined as time from the date when a patient first meets the criteria for CR or PR according to RECIST v1.1 or Lugano 2014 criteria, until the date that progressive disease (PD) is objectively documented or death, whichever occurs first.
measure: Disease control rate (DCR)
time frame: 24 months
description: PFS is defined as the time from first dose of SCT200 until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 or Lugano 2014 criteria.
measure: Progression free survival (PFS)
time frame: 24 months
description: PFS is defined as the time from first dose of SCT200 until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 or Lugano 2014 criteria.
measure: Overall survival (OS)
time frame: 24 months
description: OS is defined as time from first dose of SCT200 until the date of death from any cause.
arm group label: Low dose group
arm group type: Experimental
description: SCT-I10A will be administered at a dose of 60mg, Q3W up to 24 months.
arm group label: Middle dose group
arm group type: Experimental
description: SCT-I10A will be administered at a dose of 200mg, Q3W up to 24 months.
arm group label: High dose group
arm group type: Experimental
description: SCT-I10A will be administered at a dose of 600mg, Q3W up to 24 months.
intervention type: Biological
intervention name: SCT-I10A
description: Experimental: Anti- PD-1 monoclonal antibody（SCT-I10A）
arm group label: High dose group
arm group label: Low dose group
arm group label: Middle dose group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: jianming xu, MD
phone: +8613910866712
email: jmxu2003@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Lymphoma