xml: <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/NCT05980481</url>
    </required_header>
    <id_info>
      <org_study_id>RC48-C027</org_study_id>
      <nct_id>NCT05980481</nct_id>
    </id_info>
    <brief_title>A Study of RC48-ADC Combination Therapies as First-line Treatment in Advanced Metastatic Gastric Cancer</brief_title>
    <official_title>A Study of RC48-ADC Combine With Toripalimab and Chemotherapy or RC48-ADC Combine With Toripalimab and Herceptin as First-line Treatment in Local Advanced or Metastatic Gastric Cancer With the HER2 Expression</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>RemeGen Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>RemeGen 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>
        This is a Phase II/III, randomized, multicenter, open-label clinical trial designed to&#xD;
        evaluate safety and efficacy of RC48-ADC combine with Toripalimab and chemotherapy or&#xD;
        RC48-ADC combine with Toripalimab and Herceptin as first-line treatment in human epidermal&#xD;
        growth factor receptor 2 (HER2)-expression participants with locally advanced or metastatic&#xD;
        gastric cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a Phase II/III, randomized, multicenter, open-label clinical trial designed to&#xD;
        evaluate safety and efficacy of RC48-ADC combine with Toripalimab and chemotherapy or&#xD;
        RC48-ADC combine with Toripalimab and Herceptin as first-line treatment in human epidermal&#xD;
        growth factor receptor 2 (HER2)-expression participants with locally advanced or metastatic&#xD;
        gastric cancer. The HER2-expression is defined as: the HER2 IHC 3+ or 2+, or 1+.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">July 10, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 10, 2024</primary_completion_date>
    <phase>Phase 2/Phase 3</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>Safety(adverse event)</measure>
      <time_frame>Up to approximately 2 years</time_frame>
      <description>to evaluate safety including adverse event rate and adverse event grade.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Objective remission rate (ORR)</measure>
      <time_frame>Up to approximately 2 years</time_frame>
      <description>The objective response rate will be mainly analyzed by according to the RECIST 1.1 standard tumor evaluation by the investigator will be performed).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival (PFS), evaluated by the investigator</measure>
      <time_frame>Up to approximately 2 years</time_frame>
      <description>Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>Up to approximately 2 years</time_frame>
      <description>Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of relief (DOR)</measure>
      <time_frame>Up to approximately 2 years</time_frame>
      <description>DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Gastric Cancer</condition>
    <arm_group>
      <arm_group_label>RC48-ADC+Toripalimab+CAPOX</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants with HER2 positive(IHC2+FISH+ or IHC3+) will receive of RC48-ADC every 2 weeks (Q2W), Toripalimab 2 weeks (Q2W) and CAPOX every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>RC48-ADC+Toripalimab+Herceptin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants with HER2 positive(IHC2+FISH+ or IHC3+) will receive of RC48-ADC every 2 weeks (Q2W), Toripalimab 2 weeks (Q2W) and Herceptin every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>RC48-ADC+Toripalimab+CAPOX(HER2-low)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants with HER2-low (IHC1+) will receive of RC48-ADC every 2 weeks (Q2W), Toripalimab 2 weeks (Q2W) and CAPOX every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>RC48-ADC</intervention_name>
      <description>2.5 mg/kg IV every 2 weeks</description>
      <arm_group_label>RC48-ADC+Toripalimab+CAPOX</arm_group_label>
      <arm_group_label>RC48-ADC+Toripalimab+CAPOX(HER2-low)</arm_group_label>
      <arm_group_label>RC48-ADC+Toripalimab+Herceptin</arm_group_label>
      <other_name>Disitamab Vedotin</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Herceptin</intervention_name>
      <description>First load dose is 8.0mg , then 6.0 mg/kg IV every 3 weeks</description>
      <arm_group_label>RC48-ADC+Toripalimab+Herceptin</arm_group_label>
      <other_name>Trastuzumab</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Toripalimab</intervention_name>
      <description>3.0 mg/kg IV every 2 weeks</description>
      <arm_group_label>RC48-ADC+Toripalimab+CAPOX</arm_group_label>
      <arm_group_label>RC48-ADC+Toripalimab+CAPOX(HER2-low)</arm_group_label>
      <arm_group_label>RC48-ADC+Toripalimab+Herceptin</arm_group_label>
      <other_name>JS001</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Oxaliplatin injection</intervention_name>
      <description>100mg/m2 Q3W</description>
      <arm_group_label>RC48-ADC+Toripalimab+CAPOX</arm_group_label>
      <arm_group_label>RC48-ADC+Toripalimab+CAPOX(HER2-low)</arm_group_label>
      <other_name>Oxaliplatin</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Capecitabine</intervention_name>
      <description>1000mg/m2 Q3W</description>
      <arm_group_label>RC48-ADC+Toripalimab+CAPOX</arm_group_label>
      <arm_group_label>RC48-ADC+Toripalimab+CAPOX(HER2-low)</arm_group_label>
      <other_name>Capecitabine Tablets</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Voluntary agreement to provide written informed consent.&#xD;
  &#xD;
            -  Age:18-70 years（including 18 and 70）.&#xD;
  &#xD;
            -  Predicted survival ≥ 12 weeks.&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.&#xD;
  &#xD;
            -  Adequate organ function.&#xD;
  &#xD;
            -  All subjects must have inoperable, advanced or metastatic gastric or or&#xD;
               gastroesophageal adenocarcinoma.&#xD;
  &#xD;
            -  Subject must be previously untreated with systemic treatment; Subject that received&#xD;
               neoadjuvant chemotherapy with recurrence &gt;6 months from completion of therapy are&#xD;
               permitted;&#xD;
  &#xD;
            -  HER2-expressing status determined by laboratory to be IHC 1+, 2+ or 3+.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Active central nervous system (CNS) metastases.&#xD;
  &#xD;
            -  Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV)&#xD;
               infection.&#xD;
  &#xD;
            -  History of other malignancy within the previous 5 years, except for appropriately&#xD;
               treated carcinoma in situ of the cervix, thyroid cancer ,etal.&#xD;
  &#xD;
            -  Known hypersensitivity to antibody-drug conjugate(ADC) or PD-(L)1 or any of its&#xD;
               components.&#xD;
  &#xD;
            -  Assessed by the investigator to be unable or unwilling to comply with the requirements&#xD;
               of the protocol.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Na Su, PhD</last_name>
      <role>Study Director</role>
      <affiliation>RemeGen Co., Ltd.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jian min Fang, PhD</last_name>
      <phone>+86-010-58075561</phone>
      <email>jianminfang@hotmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lin Shen, PhD</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Beijing Cancer Hospital</name>
        <address>
          <city>Beijing</city>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Lin Shen, PhD</last_name>
        <phone>010-53806898</phone>
        <email>linshenpku@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>RC48-ADC</keyword>
    <keyword>HER2 expression</keyword>
    <keyword>Gastric cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stomach Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Capecitabine</mesh_term>
      <mesh_term>Oxaliplatin</mesh_term>
      <mesh_term>Trastuzumab</mesh_term>
      <mesh_term>Disitamab vedotin</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05980481
  org study id: RC48-C027
  nct id: NCT05980481
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a Phase II/III, randomized, multicenter, open-label clinical trial designed to
        evaluate safety and efficacy of RC48-ADC combine with Toripalimab and chemotherapy or
        RC48-ADC combine with Toripalimab and Herceptin as first-line treatment in human epidermal
        growth factor receptor 2 (HER2)-expression participants with locally advanced or metastatic
        gastric cancer.
  This is a Phase II/III, randomized, multicenter, open-label clinical trial designed to
        evaluate safety and efficacy of RC48-ADC combine with Toripalimab and chemotherapy or
        RC48-ADC combine with Toripalimab and Herceptin as first-line treatment in human epidermal
        growth factor receptor 2 (HER2)-expression participants with locally advanced or metastatic
        gastric cancer. The HER2-expression is defined as: the HER2 IHC 3+ or 2+, or 1+.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Safety(adverse event)
  time frame: Up to approximately 2 years
  description: to evaluate safety including adverse event rate and adverse event grade.
  measure: Objective remission rate (ORR)
  time frame: Up to approximately 2 years
  description: The objective response rate will be mainly analyzed by according to the RECIST 1.1 standard tumor evaluation by the investigator will be performed).
  measure: Progression-free survival (PFS), evaluated by the investigator
  time frame: Up to approximately 2 years
  description: Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.
  measure: Overall survival (OS)
  time frame: Up to approximately 2 years
  description: Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject.
  measure: Duration of relief (DOR)
  time frame: Up to approximately 2 years
  description: DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death
  arm group label: RC48-ADC+Toripalimab+CAPOX
  arm group type: Experimental
  description: Participants with HER2 positive(IHC2+FISH+ or IHC3+) will receive of RC48-ADC every 2 weeks (Q2W), Toripalimab 2 weeks (Q2W) and CAPOX every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).
  arm group label: RC48-ADC+Toripalimab+Herceptin
  arm group type: Experimental
  description: Participants with HER2 positive(IHC2+FISH+ or IHC3+) will receive of RC48-ADC every 2 weeks (Q2W), Toripalimab 2 weeks (Q2W) and Herceptin every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).
  arm group label: RC48-ADC+Toripalimab+CAPOX(HER2-low)
  arm group type: Experimental
  description: Participants with HER2-low (IHC1+) will receive of RC48-ADC every 2 weeks (Q2W), Toripalimab 2 weeks (Q2W) and CAPOX every 3 weeks (Q3W) , as one treatment period until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).
  intervention type: Drug
  intervention name: RC48-ADC
  description: 2.5 mg/kg IV every 2 weeks
  arm group label: RC48-ADC+Toripalimab+CAPOX
  arm group label: RC48-ADC+Toripalimab+CAPOX(HER2-low)
  arm group label: RC48-ADC+Toripalimab+Herceptin
  other name: Disitamab Vedotin
  intervention type: Drug
  intervention name: Herceptin
  description: First load dose is 8.0mg , then 6.0 mg/kg IV every 3 weeks
  arm group label: RC48-ADC+Toripalimab+Herceptin
  other name: Trastuzumab
  intervention type: Drug
  intervention name: Toripalimab
  description: 3.0 mg/kg IV every 2 weeks
  arm group label: RC48-ADC+Toripalimab+CAPOX
  arm group label: RC48-ADC+Toripalimab+CAPOX(HER2-low)
  arm group label: RC48-ADC+Toripalimab+Herceptin
  other name: JS001
  intervention type: Drug
  intervention name: Oxaliplatin injection
  description: 100mg/m2 Q3W
  arm group label: RC48-ADC+Toripalimab+CAPOX
  arm group label: RC48-ADC+Toripalimab+CAPOX(HER2-low)
  other name: Oxaliplatin
  intervention type: Drug
  intervention name: Capecitabine
  description: 1000mg/m2 Q3W
  arm group label: RC48-ADC+Toripalimab+CAPOX
  arm group label: RC48-ADC+Toripalimab+CAPOX(HER2-low)
  other name: Capecitabine Tablets
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Na Su, PhD
  role: Study Director
  affiliation: RemeGen Co., Ltd.
  last name: Jian min Fang, PhD
  phone: +86-010-58075561
  email: jianminfang@hotmail.com
  last name: Lin Shen, PhD
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Stomach Neoplasms
  mesh term: Capecitabine
  mesh term: Oxaliplatin
  mesh term: Trastuzumab
  mesh term: Disitamab vedotin