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/NCT05983133</url>
    </required_header>
    <id_info>
      <org_study_id>SGNEGFRd2-001</org_study_id>
      <nct_id>NCT05983133</nct_id>
    </id_info>
    <brief_title>A Study of SGN-EGFRd2 in Advanced Solid Tumors</brief_title>
    <official_title>A Phase 1 Study of SGN-EGFRd2 in Advanced Solid Tumors</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 study will test the safety of a drug called SGN-EGFRd2 in participants with advanced&#xD;
        solid tumors. It will also study the side effects of this drug. A side effect is anything a&#xD;
        drug does to the body besides treating the disease.&#xD;
  &#xD;
        Participants will have cancer that cannot be removed (unresectable) or has spread through the&#xD;
        body (metastatic).&#xD;
  &#xD;
        This study will have three parts. Parts A and B of the study will find out how much&#xD;
        SGN-EGFRd2 should be given to participants. Part C will use the dose found in parts A and B&#xD;
        to find out how safe SGN-EGFRd2 is and if it works to treat solid tumor cancers.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2028</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2027</primary_completion_date>
    <phase>Phase 1</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>Number of participants with adverse events (AEs)</measure>
      <time_frame>Through 90 days after last study treatment, up to approximately 1 year</time_frame>
      <description>An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with laboratory abnormalities</measure>
      <time_frame>Through 30-37 days after last study treatment, up to approximately 1 year</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with dose limiting toxicities (DLTs)</measure>
      <time_frame>Up to 35 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with DLTs by dose level</measure>
      <time_frame>Up to 35 days</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants with antidrug antibodies (ADAs)</measure>
      <time_frame>Through 30-37 days after last study treatment, up to approximately 1 year</time_frame>
      <description>To be summarized using descriptive statistics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetic (PK) parameter - Area under the curve (AUC)</measure>
      <time_frame>Through 30-37 days after last study treatment, up to approximately 1 year</time_frame>
      <description>To be summarized using descriptive statistics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK parameter - Maximum concentration (Cmax)</measure>
      <time_frame>Through 30-37 days after last study treatment, up to approximately 1 year</time_frame>
      <description>To be summarized using descriptive statistics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK parameter - Time to maximum concentration (Tmax)</measure>
      <time_frame>Through 30-37 days after last study treatment, up to approximately 1 year</time_frame>
      <description>To be summarized using descriptive statistics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK parameter - Apparent terminal half-life (t1/2)</measure>
      <time_frame>Through 30-37 days after last study treatment, up to approximately 1 year</time_frame>
      <description>To be summarized using descriptive statistics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK parameter - Trough concentration (Ctrough)</measure>
      <time_frame>Through 30-37 days after last study treatment, up to approximately 1 year</time_frame>
      <description>To be summarized using descriptive statistics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective response rate (ORR)</measure>
      <time_frame>Up to approximately 2 years</time_frame>
      <description>ORR is defined as the proportion of participants with an objective response per Response Evaluation in Solid Tumors (RECIST) 1.1 per investigator. A participant is determined to have an objective response if, based on RECIST 1.1, they achieve a complete response (CR) or partial response (PR) after initiation of treatment and at or prior to the EOT disease assessment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response (DOR)</measure>
      <time_frame>Up to approximately 2 years</time_frame>
      <description>DOR is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression per RECIST 1.1 or to death due to any cause, whichever comes first</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival (PFS)</measure>
      <time_frame>Up to approximately 2 years</time_frame>
      <description>PFS is defined as the time from start of SGN-EGFRd2 to first documentation of disease progression or death due to any cause, whichever comes first</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>Up to approximately 3 years</time_frame>
      <description>OS is defined as the time from start of SGN-EGFRd2 to date of death due to any cause</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">275</enrollment>
    <condition>Colorectal Neoplasms</condition>
    <condition>Carcinoma, Non-Small-Cell Lung</condition>
    <condition>Squamous Cell Carcinoma of the Head and Neck</condition>
    <condition>Pancreatic Ductal Adenocarcinoma</condition>
    <arm_group>
      <arm_group_label>SGN-EGFRd2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>SGN-EGFRd2 monotherapy</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>SGN-EGFRd2</intervention_name>
      <description>Given into the vein (IV; intravenously)</description>
      <arm_group_label>SGN-EGFRd2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Tumor types:&#xD;
  &#xD;
                 -  For Part A: Participants must have disease that is relapsed, refractory, or be&#xD;
                    intolerant to standard of care therapies, and in the judgement of the&#xD;
                    investigator must have no appropriate standard therapy available at the time of&#xD;
                    enrollment. Participants must have histologically- or cytologically confirmed&#xD;
                    metastatic or unresectable solid malignancy from one of the following tumor&#xD;
                    types:&#xD;
  &#xD;
                      -  Colorectal cancer (CRC)&#xD;
  &#xD;
                      -  Non-small cell lung cancer (NSCLC)&#xD;
  &#xD;
                      -  Head and neck squamous cell cancer (HNSCC)&#xD;
  &#xD;
                 -  For Part B: Participants must have disease that is relapsed, refractory, or be&#xD;
                    intolerant to standard of care therapies, and in the judgement of the&#xD;
                    investigator must have no appropriate standard therapy available at the time of&#xD;
                    enrollment.&#xD;
  &#xD;
                      -  The tumor type(s) to be enrolled in dose optimization will be identified by&#xD;
                         the sponsor from among those specified in Part A.&#xD;
  &#xD;
                 -  For Part C: Participants must have disease that is relapsed or refractory or be&#xD;
                    intolerant to standard of care therapies as specified below, unless&#xD;
                    contraindicated:&#xD;
  &#xD;
                      -  CRC&#xD;
  &#xD;
                           -  Participants must have unresectable locally advanced or metastatic CRC.&#xD;
  &#xD;
                           -  Prior therapy: Participants must have received prior fluoropyrimidine,&#xD;
                              oxaliplatin and irinotecan. Participants with defective mismatch repair&#xD;
                              and microsatellite instability high (dMMR/MSI-H) should have received&#xD;
                              prior treatment with pembrolizumab, a nivolumab-containing regimen, or&#xD;
                              other available anti-PD-1 (programmed cell death protein 1) or anti PD&#xD;
                              L1 (programmed cell death 1 ligand) agents.&#xD;
  &#xD;
                      -  NSCLC&#xD;
  &#xD;
                           -  Participants must have unresectable locally advanced or metastatic&#xD;
                              NSCLC.&#xD;
  &#xD;
                           -  Prior therapy: Participants must have received platinum-based therapy&#xD;
                              and at least 1 PD-1/PD-L1 inhibitor. These agents may have been&#xD;
                              administered either as single agents or in combination. Participants&#xD;
                              with an activating mutation or rearrangement (eg, EGFR, anaplastic&#xD;
                              lymphoma kinase [ALK], etc.) must have received available targeted&#xD;
                              agents if eligible by biomarker status and local standard of care.&#xD;
  &#xD;
                      -  HNSCC&#xD;
  &#xD;
                           -  Participants must have unresectable locally advanced or metastatic&#xD;
                              HNSCC&#xD;
  &#xD;
                           -  Prior therapy: Participants must have received platinum-based therapy&#xD;
                              and a PD-1/PD-L1 inhibitor, if eligible by biomarker status and local&#xD;
                              standard of care. These agents may have been administered either as&#xD;
                              single agents or in combination.&#xD;
  &#xD;
                      -  Pancreatic ductal adenocarcinoma (PDAC)&#xD;
  &#xD;
                           -  Participants must have unresectable locally advanced or metastatic&#xD;
                              PDAC.&#xD;
  &#xD;
                           -  Prior therapy: Participants must have received gemcitabine- or&#xD;
                              FOLFIRINOX-based therapy.&#xD;
  &#xD;
            -  Participants should provide archival tumor tissue if available and also agree to&#xD;
               biopsies, if medically feasible&#xD;
  &#xD;
            -  An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.&#xD;
  &#xD;
            -  Measurable disease at baseline per RECIST 1.1 criteria.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of another malignancy within 3 years before the first dose of study treatment,&#xD;
               or any evidence of residual disease from a previously diagnosed malignancy. Exceptions&#xD;
               are malignancies with a negligible risk of metastasis or death&#xD;
  &#xD;
            -  Known active central nervous system metastases or leptomeningeal disease. Participants&#xD;
               with previously treated brain metastases may participate provided they are&#xD;
  &#xD;
                 -  clinically stable for at least 4 weeks prior to study entry after brain&#xD;
                    metastases treatment,&#xD;
  &#xD;
                 -  they have no new or enlarging brain metastases,&#xD;
  &#xD;
                 -  and are off of corticosteroids prescribed for symptoms associated with brain&#xD;
                    metastases for at least 7 days prior to the first dose of study drug.&#xD;
  &#xD;
            -  Treatment with an aminobisphosphonate IV (eg ibandronate, pamidronate, zoledronate,&#xD;
               etc.) within 4 weeks of the first dose of study treatment.&#xD;
  &#xD;
            -  Participants with history of thromboembolic phenomena (pulmonary embolism, deep vein&#xD;
               thrombosis, stroke, or ischemic attack) within 6 months prior to the first dose of&#xD;
               study drug, currently receiving chronic anticoagulation therapy, or with&#xD;
               contraindication to treatment for thromboembolism prophylaxis.&#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>Corinna Palanca-Wessels</last_name>
      <role>Study Director</role>
      <affiliation>Seagen Inc.</affiliation>
    </overall_official>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>CRC</keyword>
    <keyword>Colon Cancer</keyword>
    <keyword>Rectal Cancer</keyword>
    <keyword>NSCLC</keyword>
    <keyword>HNSCC</keyword>
    <keyword>PDAC</keyword>
    <keyword>Seattle Genetics</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Colorectal Neoplasms</mesh_term>
      <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
      <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
    </condition_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/NCT05983133
  org study id: SGNEGFRd2-001
  nct id: NCT05983133
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  This study will test the safety of a drug called SGN-EGFRd2 in participants with advanced
        solid tumors. It will also study the side effects of this drug. A side effect is anything a
        drug does to the body besides treating the disease.
  
        Participants will have cancer that cannot be removed (unresectable) or has spread through the
        body (metastatic).
  
        This study will have three parts. Parts A and B of the study will find out how much
        SGN-EGFRd2 should be given to participants. Part C will use the dose found in parts A and B
        to find out how safe SGN-EGFRd2 is and if it works to treat solid tumor cancers.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of participants with adverse events (AEs)
  time frame: Through 90 days after last study treatment, up to approximately 1 year
  description: An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention
  measure: Number of participants with laboratory abnormalities
  time frame: Through 30-37 days after last study treatment, up to approximately 1 year
  measure: Number of participants with dose limiting toxicities (DLTs)
  time frame: Up to 35 days
  measure: Number of participants with DLTs by dose level
  time frame: Up to 35 days
  measure: Number of participants with antidrug antibodies (ADAs)
  time frame: Through 30-37 days after last study treatment, up to approximately 1 year
  description: To be summarized using descriptive statistics
  measure: Pharmacokinetic (PK) parameter - Area under the curve (AUC)
  time frame: Through 30-37 days after last study treatment, up to approximately 1 year
  description: To be summarized using descriptive statistics
  measure: PK parameter - Maximum concentration (Cmax)
  time frame: Through 30-37 days after last study treatment, up to approximately 1 year
  description: To be summarized using descriptive statistics
  measure: PK parameter - Time to maximum concentration (Tmax)
  time frame: Through 30-37 days after last study treatment, up to approximately 1 year
  description: To be summarized using descriptive statistics
  measure: PK parameter - Apparent terminal half-life (t1/2)
  time frame: Through 30-37 days after last study treatment, up to approximately 1 year
  description: To be summarized using descriptive statistics
  measure: PK parameter - Trough concentration (Ctrough)
  time frame: Through 30-37 days after last study treatment, up to approximately 1 year
  description: To be summarized using descriptive statistics
  measure: Objective response rate (ORR)
  time frame: Up to approximately 2 years
  description: ORR is defined as the proportion of participants with an objective response per Response Evaluation in Solid Tumors (RECIST) 1.1 per investigator. A participant is determined to have an objective response if, based on RECIST 1.1, they achieve a complete response (CR) or partial response (PR) after initiation of treatment and at or prior to the EOT disease assessment.
  measure: Duration of response (DOR)
  time frame: Up to approximately 2 years
  description: DOR is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression per RECIST 1.1 or to death due to any cause, whichever comes first
  measure: Progression-free survival (PFS)
  time frame: Up to approximately 2 years
  description: PFS is defined as the time from start of SGN-EGFRd2 to first documentation of disease progression or death due to any cause, whichever comes first
  measure: Overall survival (OS)
  time frame: Up to approximately 3 years
  description: OS is defined as the time from start of SGN-EGFRd2 to date of death due to any cause
  arm group label: SGN-EGFRd2
  arm group type: Experimental
  description: SGN-EGFRd2 monotherapy
  intervention type: Drug
  intervention name: SGN-EGFRd2
  description: Given into the vein (IV; intravenously)
  arm group label: SGN-EGFRd2
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Corinna Palanca-Wessels
  role: Study Director
  affiliation: Seagen Inc.
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Colorectal Neoplasms
  mesh term: Carcinoma, Non-Small-Cell Lung
  mesh term: Squamous Cell Carcinoma of Head and Neck