<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/NCT02216890</url>
  </required_header>
  <id_info>
    <org_study_id>SGN70A-001</org_study_id>
    <nct_id>NCT02216890</nct_id>
  </id_info>
  <brief_title>Safety Study of SGN-CD70A in Cancer Patients</brief_title>
  <official_title>A Phase 1 Trial of SGN-CD70A in Patients With CD70-Positive Malignancies</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine the safety profile of SGN-CD70A. The study will test increasing doses&#xD;
      of SGN-CD70A given every 3 weeks (or an alternate dosing schedule up to every 6 weeks) to&#xD;
      small groups of patients. The goal is to find the highest dose of SGN-CD70A that can be given&#xD;
      to patients without causing unacceptable side effects. The pharmacokinetics and antitumor&#xD;
      activity of SGN-CD70A will also be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">February 15, 2017</completion_date>
  <primary_completion_date type="Actual">February 15, 2017</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>Incidence of adverse events</measure>
    <time_frame>Through 1 month following last dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of laboratory abnormalities</measure>
    <time_frame>Through 1 month following last dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood concentrations of SGN-CD70A and metabolites</measure>
    <time_frame>Through 3 to 6 weeks after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of antitherapeutic antibodies</measure>
    <time_frame>Through 1 month following last dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate</measure>
    <time_frame>Through 1 month following last dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>Approximately 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response</measure>
    <time_frame>Approximately 3 years</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Exploratory biomarkers of pharmacodynamic effects due to SGN-CD70A</measure>
    <time_frame>Through 1 month following last dose</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Renal Cell Carcinoma</condition>
  <condition>Mantle-Cell Lymphoma</condition>
  <condition>Diffuse, Large B-Cell, Lymphoma</condition>
  <condition>Follicular Lymphoma, Grade 3</condition>
  <arm_group>
    <arm_group_label>SGN-CD70A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SGN-CD70A</intervention_name>
    <description>Given intravenously every 3 weeks (or an alternate dosing schedule up to every 6 weeks)</description>
    <arm_group_label>SGN-CD70A</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Metastatic renal cell carcinoma, mantle cell lymphoma, or diffuse large B-cell&#xD;
             lymphoma including Grade 3b follicular lymphoma&#xD;
&#xD;
          -  Relapsed, refractory, or progressive disease following at least 2 prior systemic&#xD;
             therapies&#xD;
&#xD;
          -  Confirmed positive CD70 expression on tumor tissue&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status 0 or 1&#xD;
&#xD;
          -  Adequate baseline hematologic, pulmonary, renal, and hepatic function&#xD;
&#xD;
          -  Measurable disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment with anti-CD70 directed therapy unless CD70 expression is confirmed on&#xD;
             tumor tissue obtained after the treatment&#xD;
&#xD;
          -  Patients &lt;100 days since prior allogeneic stem cell transplant&#xD;
&#xD;
          -  Less than 4 weeks since prior treatment; or 2 weeks if patient experienced disease&#xD;
             progression on the prior treatment&#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>Elaina Gartner, MD</last_name>
    <role>Study Director</role>
    <affiliation>Seagen Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City of Hope National Medical Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010-3000</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardinal Bernardin Cancer Center / Loyola University Medical Center</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan Comprehensive Cancer Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karmanos Cancer Institute / Wayne State University</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James P. Wilmot Cancer Center / University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UNC Lineberger Comprehensive Cancer Center / University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati Cancer Institute</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Case Western Reserve University / University Hospitals Case Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania / Perelman Center for Advanced Medicine</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina/Hollings Cancer Center</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Austin Midtown</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center at San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Cancer Care Alliance / University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109-1023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Cancer Specialists, P.C.</name>
      <address>
        <city>Vancouver</city>
        <state>Washington</state>
        <zip>98684</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>April 18, 2018</last_update_submitted>
  <last_update_submitted_qc>April 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Renal Cell Carcinoma</keyword>
  <keyword>Mantle-Cell Lymphoma</keyword>
  <keyword>Diffuse, Large B-Cell, Lymphoma</keyword>
  <keyword>Follicular Lymphoma, Grade 3</keyword>
  <keyword>Antibody-Drug Conjugate</keyword>
  <keyword>CD70 Antigen</keyword>
  <keyword>Drug Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Follicular</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
    <mesh_term>Lymphoma, Mantle-Cell</mesh_term>
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
  </condition_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/NCT02216890
org study id: SGN70A-001
nct id: NCT02216890
lead sponsor: 
has dmc: No
This study will examine the safety profile of SGN-CD70A. The study will test increasing doses
      of SGN-CD70A given every 3 weeks (or an alternate dosing schedule up to every 6 weeks) to
      small groups of patients. The goal is to find the highest dose of SGN-CD70A that can be given
      to patients without causing unacceptable side effects. The pharmacokinetics and antitumor
      activity of SGN-CD70A will also be evaluated.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of adverse events
time frame: Through 1 month following last dose
measure: Incidence of laboratory abnormalities
time frame: Through 1 month following last dose
measure: Blood concentrations of SGN-CD70A and metabolites
time frame: Through 3 to 6 weeks after dosing
measure: Incidence of antitherapeutic antibodies
time frame: Through 1 month following last dose
measure: Objective response rate
time frame: Through 1 month following last dose
measure: Progression-free survival
time frame: Approximately 3 years
measure: Duration of response
time frame: Approximately 3 years
measure: Exploratory biomarkers of pharmacodynamic effects due to SGN-CD70A
time frame: Through 1 month following last dose
arm group label: SGN-CD70A
arm group type: Experimental
intervention type: Drug
intervention name: SGN-CD70A
description: Given intravenously every 3 weeks (or an alternate dosing schedule up to every 6 weeks)
arm group label: SGN-CD70A
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elaina Gartner, MD
role: Study Director
affiliation: Seagen Inc.
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country: United States
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Follicular
mesh term: Carcinoma, Renal Cell
mesh term: Lymphoma, Mantle-Cell
mesh term: Lymphoma, Large B-Cell, Diffuse