<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/NCT04466254</url>
  </required_header>
  <id_info>
    <org_study_id>SSGJ-602-mCRC-II-01</org_study_id>
    <nct_id>NCT04466254</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of Combination of CPGJ602 and Chemotherapy, in First Line, With Wild KRAS/NRAS/BRAF in Metastatic Colorectal Cancer</brief_title>
  <official_title>A Phase II Study Evaluating the Efficacy and Safety of Combination of CPGJ602 and Chemotherapy as First Line Treatment in KRAS/NRAS/BRAF Wild-type, Metastatic Colorectal Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sunshine Guojian Pharmaceutical (Shanghai) 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>
      To assess the efficacy and safety of the combination of CPGJ602 and chemotherapy in subjects&#xD;
      with KRAS/NRAS/BRAF wild-type, metastatic colorectal cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open label, randomized, positive control, phase II study to treat subjects with&#xD;
      KRAS/NRAS/BRAF wild-type, unresectable metastatic colorectal cancer. The patients will be&#xD;
      randomized into three arms consist of CPGJ602 (2 weeks/cycle) + mFOLFOX6, CPGJ602 (1&#xD;
      week/cycle) + mFOLFOX6, and cetuximab (1 week/cycle) + mFOLFOX6 at a ratio of 2:2:1. This&#xD;
      study is conduct to assess the efficacy and safety of three treatments for patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 7, 2020</start_date>
  <completion_date type="Anticipated">March 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Best of Response (BOR)</measure>
    <time_frame>for 16 weeks</time_frame>
    <description>Defined as the percentage of patients whose overall response is CR or PR from day 1 to 16th week of study and maintain at least until efficacy confirmation assessment (4 weeks ± 2 days), per RECIST v1.1 for target lesions assessed by BIRC.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>for 16 weeks</time_frame>
    <description>Defined as the interval from the date of randomization until first documented disease progression or death from any cause, whichever occurs first, assessed based on tumor assessments according to RECIST v1.1 per BICR and Investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BOR Assessed by investigator</measure>
    <time_frame>for 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR)</measure>
    <time_frame>for 16 weeks</time_frame>
    <description>Defined as the percentage of patients whose overall response is CR, PR and SD from day 1 to 16th week and maintain at least until efficacy confirmation assessment (4 weeks ± 2 days), per RECIST v1.1 for target lesions assessed by BIRC and Investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>unConfirmed BOR at the end of 16th week by BICR and Investigator.</measure>
    <time_frame>for 16 weeks</time_frame>
    <description>Defined as the percentage of patients whose overall response is CR or PR from day 1 to 16th week per RECIST v1.1 for target lesions assessed by BIRC and Investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Tumor Response (TTR)</measure>
    <time_frame>for 16 weeks</time_frame>
    <description>Defined as the time from the first dose study treatment until the date of the first assessment of confirmed CR or PR, assessed by BICR and Investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Deepness of Response (DpR)</measure>
    <time_frame>for 16 weeks</time_frame>
    <description>The relative change in the sum of longest diameters of RECIST target lesions at the nadir, in the absence of new lesions or progression of non-target lesions, when compared with baseline assessed by BIRC and Investigator</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Metastatic Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CPGJ602 325mg/m2 IV Q2W； mFOLFOX6 therapy starts on day 1 and ends on day 2, then repeats every 2 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CPGJ602 400 mg/m2 IV in the first infusion， then 250mg/m2 followed per every week； mFOLFOX6 therapy starts on day 1 and ends on day 2, then repeats every 2 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>cetuximab 400 mg/m2 IV in the first infusion， then 250mg/m2 followed per every week； mFOLFOX6 therapy starts on day 1 and ends on day 2, then repeats every 2 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CPGJ602</intervention_name>
    <description>Q2W/QW iv</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cetuximab</intervention_name>
    <description>QW iv</description>
    <arm_group_label>Arm C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  informed consent to study procedures, male or female， 18-80 years old.&#xD;
&#xD;
          -  Histologically or cytologically proven diagnosis of unresectable metastatic colorectal&#xD;
             cancer&#xD;
&#xD;
          -  Patients were confirmed by central lab with KRAS, NRAS and BRAF wild type. All&#xD;
             patients must undergo a fresh tumor biopsy during the screening process, or provide&#xD;
             archived tumor samples&#xD;
&#xD;
          -  EOCG: 0~1 within 7 days prior to first treatment&#xD;
&#xD;
          -  Life expectancy of at least 3 months&#xD;
&#xD;
          -  Patients must have adequate hematology, liver and kidney function, (had been received&#xD;
             no blood transfusion, albumin, recombinant human thrombopoietin or colony stimulating&#xD;
             factor therapy, renal replacement therapy, etc. within 14 days prior to the first&#xD;
             study drug therapy, and the laboratory tests met the following requirements):&#xD;
&#xD;
        Hepatic: white blood count (WBC)≥ 3.0 × 109, absolute neutrophil count (ANC)≥ 1.5 x 109/L,&#xD;
        platelet count (PLT)≥ 100 x 109/L, haemoglobin (Hb) ≥ 90 g/dL.&#xD;
&#xD;
        Liver: total bilirubin (T-Bil)≤ 1.5 times the upper limit of normal (ULN), aspartate&#xD;
        transaminase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤5 × ULN if with&#xD;
        liver involvement) Kidney: Serum albumin ≥28 g/L, urea nitrogen 1.5 ×the ULN (If the center&#xD;
        cannot detect BUN, it could be substituted by detecting urea), serum creatinine ≤1.5 × the&#xD;
        ULN or creatinine clearance≥50mL/min&#xD;
&#xD;
          -  According to RECIST1.1, the subject should have an assessable lesion&#xD;
&#xD;
          -  Able to understand and willing to sign the Informed Consent Form (ICF)&#xD;
&#xD;
          -  Patients with good compliance assessed by investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those who have received any previous anti-tumor therapy such as salvage chemotherapy,&#xD;
             targeted therapy, biological immunotherapy, etc. (The treatment of adjuvant,&#xD;
             neoadjuvant and radiotherapy sensitized chemotherapy discontinued 6 months or more&#xD;
             [platinum containing chemotherapy should be treated for at least 12 months]. Patients&#xD;
             with disease progression can be enrolled and chemotherapy-related toxicity should be&#xD;
             restored to grade 1 or below [except for hair loss])&#xD;
&#xD;
          -  Patients who have had surgery within 28 days prior to first treatment with the study&#xD;
             drug. While, those who had primary excision or palliative ostomy with good recovery&#xD;
             within 14 days before receiving the first study drug&#xD;
&#xD;
          -  Those who received radiotherapy within 28 days prior to first dose of study drug,&#xD;
             while those who received palliative radiotherapy and recovered well within 14 days&#xD;
             prior to receiving the study drug&#xD;
&#xD;
          -  Patients with other serious uncontrolled disease (e.g. interstitial pneumonia,&#xD;
             epilepsy, hepatic failure, etc)&#xD;
&#xD;
          -  Patients had other active malignant tumor, except for the followings:&#xD;
&#xD;
        The under-treated non-melanoma skin cancer;Cured cervical cancer or basal cell carcinoma of&#xD;
        the skin, mammary gland ductal carcinoma in situ, and phase 1, grade 1 endometrial&#xD;
        carcinoma&#xD;
&#xD;
          -  Patients infected as followings; Hepatitis B: HBV DNA titer&gt; 2000 IU/ml; Hepatitis C:&#xD;
             HCV RNA titer&gt;ULN; HIV infection; Serious bacterial infection; Active mycobacterium&#xD;
             tuberculosis infection; Serious other active microbial and parasitic infections.&#xD;
&#xD;
          -  History of psychiatric, psychological illness (except for those patients whose mild&#xD;
             mental illness have been cured for more than 3 years and have no signs of recurrence&#xD;
             assessed by the researchers), or had history of alcohol or drug abuse&#xD;
&#xD;
          -  Known or suspected to have brain metastases and/or cerebrospinal meningitis&#xD;
&#xD;
          -  Patients with acute or subacute intestinal obstruction, or with a history of&#xD;
             inflammatory bowel disease， or who had gastrointestinal perforation and unhealed&#xD;
&#xD;
          -  Patients with serious cardiovascular and cerebrovascular diseases，these include but&#xD;
             are not limited to the followings:&#xD;
&#xD;
        Patients with uncontrolled hypertension (systolic blood pressure &gt;150 mmHg and/or diastolic&#xD;
        blood pressure &gt;100 mmHg under regular drug control); Patients with hypertensive crisis or&#xD;
        had a history of hypertensive encephalopathy; Cerebrovascular accidents, transient ischemic&#xD;
        attacks and myocardial infarction within 6 months prior to treatment with the study drug,&#xD;
        and significant vascular disease (including, but not limited to, aortic aneurysms or&#xD;
        proximal arterial thrombosis requiring surgical repair); Unstable angina; Heart failure&#xD;
        (NYHA ≥Ⅱ) Uncontrolled serious arrhythmia by drug (ECG QTc ≥450ms for male, and QTc≥470ms&#xD;
        for female, calculated by Fridericia formula)&#xD;
&#xD;
          -  Patients with thrombotic dysfunction: International standardized ratio (INR) or&#xD;
             activated partial thromboplastin time APTT, any of which ≥1.5×ULN&#xD;
&#xD;
          -  Patients who are known to be allergic to the study drug or its excipients, or have a&#xD;
             history of severe allergies to other monoclonal antibodies&#xD;
&#xD;
          -  Patients who are in pregnant or breastfeeding, or are unable to use reliable&#xD;
             contraception during the study and 6 months after discontinued treatmen&#xD;
&#xD;
          -  Patients received any experimental drug in other interventional clinical trials: the&#xD;
             time from stopping taking the study drug of a previous treatment to take the first&#xD;
             dose of this study drug is less than 28 days or less than 5 half-lives of the drug,&#xD;
             whichever is longer&#xD;
&#xD;
          -  Patients who have a history of organ transplant, including autologous/allogeneic stem&#xD;
             cell transplantation&#xD;
&#xD;
          -  Patients who have a history of severe dry eye and Patients who Currently suffering&#xD;
             from severe dry eye disease , keratitis,and ulcerative keratitis.&#xD;
&#xD;
          -  Other conditions which are not fit for this study assessed by investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>jianming XU, Doctor</last_name>
    <phone>86+13910866712</phone>
    <email>Jianmingxu2014@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>jianming xu, Doctor</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>August 16, 2021</last_update_submitted>
  <last_update_submitted_qc>August 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 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>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cetuximab</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/NCT04466254
org study id: SSGJ-602-mCRC-II-01
nct id: NCT04466254
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To assess the efficacy and safety of the combination of CPGJ602 and chemotherapy in subjects
      with KRAS/NRAS/BRAF wild-type, metastatic colorectal cancer.
This is an open label, randomized, positive control, phase II study to treat subjects with
      KRAS/NRAS/BRAF wild-type, unresectable metastatic colorectal cancer. The patients will be
      randomized into three arms consist of CPGJ602 (2 weeks/cycle) + mFOLFOX6, CPGJ602 (1
      week/cycle) + mFOLFOX6, and cetuximab (1 week/cycle) + mFOLFOX6 at a ratio of 2:2:1. This
      study is conduct to assess the efficacy and safety of three treatments for patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Best of Response (BOR)
time frame: for 16 weeks
description: Defined as the percentage of patients whose overall response is CR or PR from day 1 to 16th week of study and maintain at least until efficacy confirmation assessment (4 weeks ± 2 days), per RECIST v1.1 for target lesions assessed by BIRC.
measure: Progression Free Survival (PFS)
time frame: for 16 weeks
description: Defined as the interval from the date of randomization until first documented disease progression or death from any cause, whichever occurs first, assessed based on tumor assessments according to RECIST v1.1 per BICR and Investigator.
measure: BOR Assessed by investigator
time frame: for 16 weeks
measure: Disease Control Rate (DCR)
time frame: for 16 weeks
description: Defined as the percentage of patients whose overall response is CR, PR and SD from day 1 to 16th week and maintain at least until efficacy confirmation assessment (4 weeks ± 2 days), per RECIST v1.1 for target lesions assessed by BIRC and Investigator.
measure: unConfirmed BOR at the end of 16th week by BICR and Investigator.
time frame: for 16 weeks
description: Defined as the percentage of patients whose overall response is CR or PR from day 1 to 16th week per RECIST v1.1 for target lesions assessed by BIRC and Investigator.
measure: Time to Tumor Response (TTR)
time frame: for 16 weeks
description: Defined as the time from the first dose study treatment until the date of the first assessment of confirmed CR or PR, assessed by BICR and Investigator
measure: Deepness of Response (DpR)
time frame: for 16 weeks
description: The relative change in the sum of longest diameters of RECIST target lesions at the nadir, in the absence of new lesions or progression of non-target lesions, when compared with baseline assessed by BIRC and Investigator
arm group label: Arm A
arm group type: Experimental
description: CPGJ602 325mg/m2 IV Q2W； mFOLFOX6 therapy starts on day 1 and ends on day 2, then repeats every 2 weeks.
arm group label: Arm B
arm group type: Experimental
description: CPGJ602 400 mg/m2 IV in the first infusion， then 250mg/m2 followed per every week； mFOLFOX6 therapy starts on day 1 and ends on day 2, then repeats every 2 weeks
arm group label: Arm C
arm group type: Active Comparator
description: cetuximab 400 mg/m2 IV in the first infusion， then 250mg/m2 followed per every week； mFOLFOX6 therapy starts on day 1 and ends on day 2, then repeats every 2 weeks
intervention type: Drug
intervention name: CPGJ602
description: Q2W/QW iv
arm group label: Arm A
arm group label: Arm B
intervention type: Drug
intervention name: cetuximab
description: QW iv
arm group label: Arm C
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: jianming XU, Doctor
phone: 86+13910866712
email: Jianmingxu2014@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Cetuximab