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/NCT06003231</url>
    </required_header>
    <id_info>
      <org_study_id>SGNDV-005</org_study_id>
      <nct_id>NCT06003231</nct_id>
    </id_info>
    <brief_title>A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2</brief_title>
    <official_title>A Phase 2 Basket Study of Disitamab Vedotin in Adult Subjects With Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors That Express HER2</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Seagen Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Seagen Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This clinical trial is studying advanced or metastatic solid tumors. Once a solid tumor has&#xD;
        grown very large in one spot or has spread to other places in the body, it is called advanced&#xD;
        or metastatic cancer. Participants in this study must have head and neck squamous cell&#xD;
        cancer, non-small cell lung cancer, endometrial cancer, or ovarian cancer. Participants must&#xD;
        have tumors that have a marker called HER2.&#xD;
  &#xD;
        This clinical trial uses an experimental drug called disitamab vedotin (DV). DV is a type of&#xD;
        antibody-drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. In&#xD;
        this study, all participants will get DV once every 2 weeks.&#xD;
  &#xD;
        This study is being done to see if DV works to treat different types of solid tumors that&#xD;
        express HER2. It will also test how safe the drug is for participants. This trial will also&#xD;
        study what side effects happen when participants get the drug. A side effect is anything a&#xD;
        drug does to your body besides treating the disease.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">November 30, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2028</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2026</primary_completion_date>
    <phase>Phase 2</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>Confirmed Objective Response Rate (ORR) per Response Evaluation in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment</measure>
      <time_frame>Approximately 3 years</time_frame>
      <description>The proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants with adverse events (AEs)</measure>
      <time_frame>Through 30-37 days after the last dose of DV; approximately 5 years</time_frame>
      <description>Any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with laboratories abnormalities</measure>
      <time_frame>Through 30-37 days after the last dose of DV; approximately 5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with dose alterations due to AEs</measure>
      <time_frame>Approximately 5 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Confirmed Disease Control Rate (DCR) per RECIST v1.1 by investigator assessment</measure>
      <time_frame>Approximately 5 years</time_frame>
      <description>The proportion of participants with stable disease (SD) or confirmed CR or PR according to RECIST v1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DOR) per RECIST v1.1 by investigator assessment</measure>
      <time_frame>Approximately 5 years</time_frame>
      <description>The time from start of the first documentation of objective tumor response of CR or PR (that is subsequently confirmed) to the first documentation of progressive disease (PD) per RECIST v1.1, or to death due to any cause</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Progression Free Survival (PFS) per RECIST v1.1 by investigator assessment</measure>
      <time_frame>Approximately 5 years</time_frame>
      <description>The time from the start of study treatment to the first documentation of disease progression per RECIST v1.1 or death due to any cause</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Survival (OS)</measure>
      <time_frame>Approximately 5 years</time_frame>
      <description>The time from the start of study treatment to the date of death due to any cause</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetic (PK) parameter - Area under the concentration-time curve to the time of the last quantifiable concentration (AUClast)</measure>
      <time_frame>Approximately 1 month</time_frame>
      <description>Analyzed through cycle 2.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK parameter - Maximum concentration (Cmax)</measure>
      <time_frame>Through 30-37 days after the last dose of DV; approximately 5 years</time_frame>
      <description>Analyzed through end of treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK parameter - Trough concentration (Ctrough)</measure>
      <time_frame>Through 30-37 days after the last dose of DV; approximately 5 years</time_frame>
      <description>Analyzed through end of treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of antidrug antibodies (ADAs)</measure>
      <time_frame>Through 30-37 days after the last dose of DV; approximately 5 years</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">190</enrollment>
    <condition>Carcinoma, Squamous Cell of Head and Neck</condition>
    <condition>Carcinoma, Non-Small-Cell Lung</condition>
    <condition>Ovarian Neoplasms</condition>
    <condition>Endometrial Neoplasms</condition>
    <arm_group>
      <arm_group_label>Disitamab vedotin monotherapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Disitamab vedotin monotherapy</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>disitamab vedotin</intervention_name>
      <description>Given into the vein (IV, intravenous) every 2 weeks</description>
      <arm_group_label>Disitamab vedotin monotherapy</arm_group_label>
      <other_name>RC48, RC48-ADC</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Cohort 1: HNSCC&#xD;
  &#xD;
                 -  Pathologically-documented squamous cell carcinoma of the head and neck with&#xD;
                    primary tumor site arising from the oral cavity, oropharynx, hypopharynx, and&#xD;
                    larynx&#xD;
  &#xD;
                 -  Unresectable locally recurrent or metastatic stage disease&#xD;
  &#xD;
                 -  Prior therapies:&#xD;
  &#xD;
                      -  Participants must have disease progression after treatment with a&#xD;
                         platinum-based therapy&#xD;
  &#xD;
                      -  No more than 1 line of cytotoxic chemotherapy for advanced disease&#xD;
  &#xD;
            -  Cohort 2: NSCLC&#xD;
  &#xD;
                 -  Pathologically documented NSCLC&#xD;
  &#xD;
                 -  Unresectable locally-advanced or metastatic stage disease&#xD;
  &#xD;
                 -  Prior therapies&#xD;
  &#xD;
                      -  Must have progressed during or after a platinum-based therapy or, within 6&#xD;
                         months of platinum-based adjuvant, neoadjuvant, or concomitant&#xD;
                         chemoradiotherapy for early or locally-advanced stage disease&#xD;
  &#xD;
                      -  Must have received prior anti-PD(L)1 therapy, unless contraindicated&#xD;
  &#xD;
                      -  No more than 2 prior lines of cytotoxic chemotherapy for advanced disease&#xD;
  &#xD;
            -  Cohort 3: Ovarian Cancer&#xD;
  &#xD;
                 -  Pathologically documented epithelial cancers of ovarian, fallopian tube, or&#xD;
                    peritoneal origin&#xD;
  &#xD;
                 -  Unresectable locally-advanced or metastatic stage disease&#xD;
  &#xD;
                 -  Prior therapies&#xD;
  &#xD;
                      -  Must have platinum resistant disease (6 months or less between the&#xD;
                         completion of platinum-based treatment and identification of recurrence)&#xD;
  &#xD;
                      -  Must not have received more than 4 lines of prior cytotoxic chemotherapies&#xD;
                         for advanced disease&#xD;
  &#xD;
                      -  May have received prior anti-PD(L)1 therapy&#xD;
  &#xD;
            -  Cohort 4: Endometrial Cancer&#xD;
  &#xD;
                 -  Must have pathologically documented adenocarcinoma of the endometrium&#xD;
  &#xD;
                 -  Must have unresectable locally-advanced or metastatic stage disease.&#xD;
  &#xD;
                 -  Prior therapies&#xD;
  &#xD;
                      -  Must have relapsed/progressed after at least one prior platinum-based&#xD;
                         chemotherapy for recurrent, metastatic or primary unresectable disease&#xD;
  &#xD;
                      -  Must not have received more than 3 lines of prior cytotoxic chemotherapies&#xD;
                         for advanced disease&#xD;
  &#xD;
                      -  May have received prior anti-PD(L)1 therapy&#xD;
  &#xD;
            -  HER2 expression of 1+, 2+, or 3+, as determined by local IHC testing on a fresh or&#xD;
               archival tumor tissue&#xD;
  &#xD;
            -  Measurable disease per RECIST v1.1 criteria as assessed by the investigator&#xD;
  &#xD;
            -  Able to provide formalin-fixed, paraffin-embedded (FFPE) tumor tissue blocks (or&#xD;
               freshly sectioned slides)&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Prior treatment with an MMAE-containing agent.&#xD;
  &#xD;
            -  Previous treatment with HER2-directed ADCs&#xD;
  &#xD;
            -  Known hypersensitivity to any excipient contained in the drug formulation of disitamab&#xD;
               vedotin.&#xD;
  &#xD;
            -  History of another invasive malignancy within 2 years before the first dose of study&#xD;
               intervention, or any evidence of residual disease from a previously diagnosed&#xD;
               malignancy.&#xD;
  &#xD;
            -  Active untreated CNS or leptomeningeal metastasis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Xuemei Li</last_name>
      <role>Study Director</role>
      <affiliation>Seagen Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Seagen Trial Information Support</last_name>
      <phone>866-333-7436</phone>
      <email>clinicaltrials@seagen.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Eastern CT Hematology and Oncology Associates</name>
        <address>
          <city>Norwich</city>
          <state>Connecticut</state>
          <zip>06360</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nancy Wilcox</last_name>
        <phone>860-886-8362</phone>
        <email>nwilcox@echoct.com</email>
      </contact>
      <investigator>
        <last_name>Dennis Slater</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Gabrail Cancer Center Research, LLC</name>
        <address>
          <city>Canton</city>
          <state>Ohio</state>
          <zip>44718</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Amanda Rich</last_name>
        <phone>330-492-3345</phone>
        <email>arich@gabrailcancercenter.com</email>
      </contact>
      <investigator>
        <last_name>Nashat Gabrail</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Renovatio Clinical</name>
        <address>
          <city>El Paso</city>
          <state>Texas</state>
          <zip>79915</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Maritza Seanez</last_name>
        <phone>713-703-2398</phone>
        <email>maritza.seanez@renovatioclinical.com</email>
      </contact>
      <investigator>
        <last_name>Haroutioun Shahinian</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Renovatio Clinical</name>
        <address>
          <city>The Woodlands</city>
          <state>Texas</state>
          <zip>77380</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Pablo Villarreal</last_name>
        <phone>713-703-2398</phone>
      </contact>
      <investigator>
        <last_name>Jonathan Lu</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>HNSCC</keyword>
    <keyword>NSCLC</keyword>
    <keyword>Ovarian Cancer</keyword>
    <keyword>Endometrial Cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Neoplasms</mesh_term>
      <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
      <mesh_term>Ovarian Neoplasms</mesh_term>
      <mesh_term>Carcinoma, Squamous Cell</mesh_term>
      <mesh_term>Endometrial Neoplasms</mesh_term>
      <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Disitamab vedotin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06003231
  org study id: SGNDV-005
  nct id: NCT06003231
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  This clinical trial is studying advanced or metastatic solid tumors. Once a solid tumor has
        grown very large in one spot or has spread to other places in the body, it is called advanced
        or metastatic cancer. Participants in this study must have head and neck squamous cell
        cancer, non-small cell lung cancer, endometrial cancer, or ovarian cancer. Participants must
        have tumors that have a marker called HER2.
  
        This clinical trial uses an experimental drug called disitamab vedotin (DV). DV is a type of
        antibody-drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. In
        this study, all participants will get DV once every 2 weeks.
  
        This study is being done to see if DV works to treat different types of solid tumors that
        express HER2. It will also test how safe the drug is for participants. This trial will also
        study what side effects happen when participants get the drug. A side effect is anything a
        drug does to your body besides treating the disease.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Confirmed Objective Response Rate (ORR) per Response Evaluation in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment
  time frame: Approximately 3 years
  description: The proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator
  measure: Number of participants with adverse events (AEs)
  time frame: Through 30-37 days after the last dose of DV; approximately 5 years
  description: Any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention
  measure: Number of participants with laboratories abnormalities
  time frame: Through 30-37 days after the last dose of DV; approximately 5 years
  measure: Number of participants with dose alterations due to AEs
  time frame: Approximately 5 years
  measure: Confirmed Disease Control Rate (DCR) per RECIST v1.1 by investigator assessment
  time frame: Approximately 5 years
  description: The proportion of participants with stable disease (SD) or confirmed CR or PR according to RECIST v1.1
  measure: Duration of Response (DOR) per RECIST v1.1 by investigator assessment
  time frame: Approximately 5 years
  description: The time from start of the first documentation of objective tumor response of CR or PR (that is subsequently confirmed) to the first documentation of progressive disease (PD) per RECIST v1.1, or to death due to any cause
  measure: Duration of Progression Free Survival (PFS) per RECIST v1.1 by investigator assessment
  time frame: Approximately 5 years
  description: The time from the start of study treatment to the first documentation of disease progression per RECIST v1.1 or death due to any cause
  measure: Overall Survival (OS)
  time frame: Approximately 5 years
  description: The time from the start of study treatment to the date of death due to any cause
  measure: Pharmacokinetic (PK) parameter - Area under the concentration-time curve to the time of the last quantifiable concentration (AUClast)
  time frame: Approximately 1 month
  description: Analyzed through cycle 2.
  measure: PK parameter - Maximum concentration (Cmax)
  time frame: Through 30-37 days after the last dose of DV; approximately 5 years
  description: Analyzed through end of treatment.
  measure: PK parameter - Trough concentration (Ctrough)
  time frame: Through 30-37 days after the last dose of DV; approximately 5 years
  description: Analyzed through end of treatment.
  measure: Incidence of antidrug antibodies (ADAs)
  time frame: Through 30-37 days after the last dose of DV; approximately 5 years
  arm group label: Disitamab vedotin monotherapy
  arm group type: Experimental
  description: Disitamab vedotin monotherapy
  intervention type: Drug
  intervention name: disitamab vedotin
  description: Given into the vein (IV, intravenous) every 2 weeks
  arm group label: Disitamab vedotin monotherapy
  other name: RC48, RC48-ADC
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Xuemei Li
  role: Study Director
  affiliation: Seagen Inc.
  last name: Seagen Trial Information Support
  phone: 866-333-7436
  email: clinicaltrials@seagen.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Neoplasms
  mesh term: Carcinoma, Non-Small-Cell Lung
  mesh term: Ovarian Neoplasms
  mesh term: Carcinoma, Squamous Cell
  mesh term: Endometrial Neoplasms
  mesh term: Squamous Cell Carcinoma of Head and Neck
  mesh term: Disitamab vedotin
  sharing ipd: No