<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/NCT02211443</url>
  </required_header>
  <id_info>
    <org_study_id>SCT200mCRCI</org_study_id>
    <nct_id>NCT02211443</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Pharmacokinetics of Recombinant Anti-epidermal Growth Factor Receptor(EGFR) Monoclonal Antibody in Patients With Metastatic Colorectal Cancer</brief_title>
  <official_title>A Phase I Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of SCT200, a Recombinant Full Human Anti-epidermal Growth Factor Receptor(EGFR) Monoclonal Antibody，in Patients With Metastatic Colorectal Cancer Following Fluoropyrimidine, Irinotecan and Oxaliplatine Chemotherapy Regiment</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether SCT200 is safe and tolerant in the&#xD;
      treatment of metastatic colorectal cancer&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>January 2015</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2015</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with SCT200-related adverse events</measure>
    <time_frame>up to 105 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under the plasma concentration versus time curve (AUC) of SCT200</measure>
    <time_frame>prior to the initial dose and 0,0.5,1,2,4,8,24,48 hours,4,7,14,21days post- first dose</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Time to Disease Progression (TTP) of SCT200</measure>
    <time_frame>up to 105 days</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">21</enrollment>
  <condition>Metastatic Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Single arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two phase study of Recombinant full human Anti-epidermal growth factor receptor(EGFR) Monoclonal Antibody:&#xD;
First phase: seven escalating single-dose groups : 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0 mg/kg&#xD;
Second phase: multiple-dose groups 0.5, 1.0, 2.0, 3.0 mg/kg: weekly once for 4 doses; 5.0, 6.0 mg/kg: every two weeks for 2 doses; 4.0 mg/kg: weekly or every two weeks depends on the results of previous dose groups.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Recombinant full human Anti-EGFR Monoclonal Antibody</intervention_name>
    <arm_group_label>Single arm</arm_group_label>
    <other_name>SCT200</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged from 18 to 70 years;&#xD;
&#xD;
          -  having histologically confirmed metastatic colorectal cancer;&#xD;
&#xD;
          -  having experienced previous treatment failures including fluoropyrimidine, irinotecan&#xD;
             and oxaliplatine chemotherapy regiment;&#xD;
&#xD;
          -  having determined wild-type KRAS tumor;&#xD;
&#xD;
          -  having to have measurable or nonmeasurable disease per Response Evaluation Criteria In&#xD;
             Solid Tumors (RECIST) version 1.1;&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; and expected&#xD;
             survival of at least ≥3 months;&#xD;
&#xD;
          -  adequate hematological, renal and liver functions:&#xD;
&#xD;
               1. Hematological function: white blood cell count of &gt;4.0×109/L; absolute neutrophil&#xD;
                  count of &gt;1.5×109/ L; platelet count of &gt;100×109/L; hemoglobin level of &gt;90.0&#xD;
                  g/L;&#xD;
&#xD;
               2. Renal function: serum creatinine level of&lt;1.5×upper limit of normal (ULN);&#xD;
&#xD;
               3. Liver function: total bilirubin level of&lt;1.5×ULN; aspartate amino transferase&#xD;
                  (AST) and alanine amino transferase (ALT) levels of &lt;1.5×ULN; or &lt;5 × ULN for&#xD;
                  patients with liver metastases;&#xD;
&#xD;
          -  no other malignancies only if they had following malignancies , which were not&#xD;
             required to treat or who had curative resection: cervical carcinoma in situ, the skin&#xD;
             basal carcinoma or squamous cell carcinoma, bladder epithelial tumors, or only they&#xD;
             had some malignancies requirement only surgical therapy and disease free survival≥5&#xD;
             years;&#xD;
&#xD;
          -  no serious nonmalignant diseases including hypertension, diabetes mellitus, coronary&#xD;
             artery disease, and mental disorder.&#xD;
&#xD;
          -  not pregnant; or not lactating; or accepted birth control methods during the study;&#xD;
&#xD;
          -  signed an informed consent form which was approved by the institutional review board&#xD;
             of the respective medical center .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  had received EGFR target treatment including EGFR tyrosine kinase inhibitors(TKI), or&#xD;
             anti- EGFR monoclonal antibody;&#xD;
&#xD;
          -  having to be at least 4 weeks beyond prior anticancer therapy (including&#xD;
             corticosteroid , or nitrosourea or mitomycin within 6 weeks of study entry) or&#xD;
             participating in other clinical trial, or have not recovered from significant&#xD;
             toxicities of prior therapy;&#xD;
&#xD;
          -  chronic use of medication that could interfere with the assessment of drug-related&#xD;
             toxicities or immunologic activity (high dose prednisone or high dose non-steroid&#xD;
             anti-inflammatory medication);&#xD;
&#xD;
          -  had recent major surgery (within 28 days);&#xD;
&#xD;
          -  with symptomatically brain metastases (with the exception of clinically brain&#xD;
             metastases stable and of no requirement further treatment);&#xD;
&#xD;
          -  with active infection requirement systemic antibiotics treatment; or serious&#xD;
             cardiovascular disease;or with evidence of active hepatitis B or C infection; or with&#xD;
             human immunodeficiency virus infection;&#xD;
&#xD;
          -  had acute pulmonary disorder; or interstitial pneumonia; or symptomatically chronic&#xD;
             obstructive pulmonary disease (COPD) or with risk factors to COPD;&#xD;
&#xD;
          -  with eye inflammation or infection, or any risk factors who could lead to eye disease;&#xD;
&#xD;
          -  with a history of allergic reaction or protein product allergy including antibodies&#xD;
             product;&#xD;
&#xD;
          -  pregnant, or lactating, or not accepted birth control methods including male patients.&#xD;
&#xD;
          -  had a history of alcohol or drugs addiction, or with any risk which may affect the&#xD;
             patient's health evaluation or mantle state&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>April 8, 2015</last_update_submitted>
  <last_update_submitted_qc>April 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Full human anti-EGFR monoclonal antibody (SCT200) ;</keyword>
  <keyword>metastatic colorectal cancer （mCRC）;</keyword>
  <keyword>Escalating doses ;</keyword>
  <keyword>single dose and multiple doses;</keyword>
  <keyword>safety, tolerability and pharmacokinetics.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</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/NCT02211443
org study id: SCT200mCRCI
nct id: NCT02211443
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether SCT200 is safe and tolerant in the
      treatment of metastatic colorectal cancer
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with SCT200-related adverse events
time frame: up to 105 days
measure: Area Under the plasma concentration versus time curve (AUC) of SCT200
time frame: prior to the initial dose and 0,0.5,1,2,4,8,24,48 hours,4,7,14,21days post- first dose
measure: Time to Disease Progression (TTP) of SCT200
time frame: up to 105 days
arm group label: Single arm
arm group type: Experimental
description: Two phase study of Recombinant full human Anti-epidermal growth factor receptor(EGFR) Monoclonal Antibody:
First phase: seven escalating single-dose groups : 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0 mg/kg
Second phase: multiple-dose groups 0.5, 1.0, 2.0, 3.0 mg/kg: weekly once for 4 doses; 5.0, 6.0 mg/kg: every two weeks for 2 doses; 4.0 mg/kg: weekly or every two weeks depends on the results of previous dose groups.
intervention type: Biological
intervention name: Recombinant full human Anti-EGFR Monoclonal Antibody
arm group label: Single arm
other name: SCT200
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Antibodies
mesh term: Antibodies, Monoclonal