<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/NCT03752398</url>
  </required_header>
  <id_info>
    <org_study_id>XmAb23104-01</org_study_id>
    <secondary_id>DUET-3</secondary_id>
    <nct_id>NCT03752398</nct_id>
  </id_info>
  <brief_title>A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)</brief_title>
  <acronym>DUET-3</acronym>
  <official_title>A Phase 1 Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb®23104 in Subjects With Selected Advanced Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xencor, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ICON plc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Xencor, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</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 is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and&#xD;
      regimen of XmAb23104, to describe safety and tolerability, to assess PK and immunogenicity,&#xD;
      and to preliminarily assess anti-tumor activity of XmAb23104 monotherapy and combination&#xD;
      therapy with ipilimumab in subjects with selected advanced solid tumors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Anticipated">September 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment-related adverse events as assessed by CTCAE v4.03</measure>
    <time_frame>56 Days</time_frame>
    <description>Safety and tolerability</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Melanoma (Excluding Uveal Melanoma)</condition>
  <condition>Cervical Carcinoma</condition>
  <condition>Pancreatic Carcinoma</condition>
  <condition>Breast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative</condition>
  <condition>Hepatocellular Carcinoma</condition>
  <condition>Urothelial Carcinoma</condition>
  <condition>Squamous Cell Carcinoma of the Head and Neck</condition>
  <condition>Nasopharyngeal Carcinoma</condition>
  <condition>Renal Cell Carcinoma</condition>
  <condition>Colorectal Carcinoma</condition>
  <condition>Endometrial Carcinoma</condition>
  <condition>Non-small Cell Lung Carcinoma</condition>
  <condition>Small Cell Lung Cancer</condition>
  <condition>Gastric or Gastroesophageal Junction Adenocarcinoma</condition>
  <condition>Advanced Solid Tumors</condition>
  <condition>Undifferentiated Pleomorphic Sarcoma</condition>
  <arm_group>
    <arm_group_label>XmAb®23104 Monotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>XmAb®23104 administered by IV dosing on Days 1 and 15 of each 28-day cycle x 2 cycles</description>
  </arm_group>
  <arm_group>
    <arm_group_label>XmAb®23104 Combination Therapy with Ipilimumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>XmAb®23104 administered by IV on Days 1 and 15 of each 28-day cycle x 2 cycles + Yervoy® (ipilimumab)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>XmAb®23104</intervention_name>
    <description>Monoclonal bispecific antibody</description>
    <arm_group_label>XmAb®23104 Combination Therapy with Ipilimumab</arm_group_label>
    <arm_group_label>XmAb®23104 Monotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Yervoy® (ipilimumab)</intervention_name>
    <description>Monoclonal antibody</description>
    <arm_group_label>XmAb®23104 Combination Therapy with Ipilimumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects in Part A (dose escalation) must have a diagnosis of any of the following:&#xD;
&#xD;
             Histologically or cytologically confirmed advanced solid tumors, including the&#xD;
             following:&#xD;
&#xD;
               1. Melanoma (excluding uveal melanoma)&#xD;
&#xD;
               2. Cervical carcinoma&#xD;
&#xD;
               3. Pancreatic carcinoma&#xD;
&#xD;
               4. Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2&#xD;
                  negative&#xD;
&#xD;
               5. Hepatocellular carcinoma&#xD;
&#xD;
               6. Urothelial carcinoma&#xD;
&#xD;
               7. Squamous cell carcinoma of the head and neck&#xD;
&#xD;
               8. Nasopharyngeal carcinoma&#xD;
&#xD;
               9. Renal cell carcinoma&#xD;
&#xD;
              10. Colorectal carcinoma&#xD;
&#xD;
              11. Endometrial carcinoma&#xD;
&#xD;
              12. NSCLC&#xD;
&#xD;
              13. Small cell lung cancer&#xD;
&#xD;
              14. Gastric or gastroesophageal junction adenocarcinoma&#xD;
&#xD;
              15. Sarcoma&#xD;
&#xD;
          2. Subjects in Part B (expansion) must have a diagnosis of any of the following:&#xD;
&#xD;
             Histologically or cytologically confirmed advanced solid tumors of the following&#xD;
             types:&#xD;
&#xD;
               1. Non-squamous NSCLC&#xD;
&#xD;
               2. Melanoma&#xD;
&#xD;
               3. HNSCC, including NPC&#xD;
&#xD;
               4. CRC&#xD;
&#xD;
               5. UPS, including other select high grade STS, such as MFS&#xD;
&#xD;
               6. ccRCC&#xD;
&#xD;
             Prior to enrolling into Part B (expansion), subjects should have received&#xD;
             disease-specific standard therapy as indicated for:&#xD;
&#xD;
               1. Non-squamous NSCLC&#xD;
&#xD;
               2. Melanoma&#xD;
&#xD;
               3. HNSCC, including NPC&#xD;
&#xD;
               4. CRC&#xD;
&#xD;
               5. UPS, including other select high-grade STS such as MFS&#xD;
&#xD;
               6. RCC, clear cell histology (ccRCC)&#xD;
&#xD;
          3. Subjects in Part C (expansion)must have a diagnosis of MSS or proficient mismatch&#xD;
             repair CRC with the following:&#xD;
&#xD;
               1. cancer must have progressed after treatment with standard/approved therapies or&#xD;
                  have no appropriate available therapies&#xD;
&#xD;
               2. subjects will have life expectancy greater than 3 months&#xD;
&#xD;
          4. All subjects' cancer must have progressed after treatment with standard/approved&#xD;
             therapies or have no appropriate available therapies.&#xD;
&#xD;
          5. Subjects must have measurable disease by RECIST 1.1.&#xD;
&#xD;
          6. All subjects must have adequate archival tumor sample (slides or archival FFPE&#xD;
             block[s] containing tumor.&#xD;
&#xD;
          7. All subjects in Part B (dose expansion) must have a tumor lesion that can be biopsied&#xD;
             at acceptable risk (in the judgment of the Investigator) and must agree to both a&#xD;
             fresh biopsy during screening and a second biopsy following treatment.&#xD;
&#xD;
          8. Subjects have an ECOG performance status of 0-1.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Currently receiving other anticancer therapies&#xD;
&#xD;
          2. Prior treatment with an investigational anti-ICOS therapy&#xD;
&#xD;
          3. Treatment with any PDL1 or PDL2-directed therapy within 4 weeks of the start of study&#xD;
             drug&#xD;
&#xD;
          4. Treatment with nivolumab within 4 weeks of the start of study drug&#xD;
&#xD;
          5. Treatment with pembrolizumab within 24 weeks of start of study drug for Cohorts 1A -&#xD;
             10A&#xD;
&#xD;
          6. Treatment with any other anticancer therapy within 2 weeks of the start of study drug&#xD;
             (ie, other immunotherapy, chemotherapy, radiation therapy, etc.)&#xD;
&#xD;
          7. A life-threatening (Grade 4) irAE related to prior immunotherapy&#xD;
&#xD;
          8. Failure to recover from any irAE from prior cancer therapy to Grade ≤ 1, except for&#xD;
             endocrinopathies that are on stable hormone replacement doses&#xD;
&#xD;
          9. Failure to recover from any other toxicity (other than immune-related toxicity)&#xD;
             related to previous anticancer treatment to Grade ≤ 2&#xD;
&#xD;
         10. Known active central nervous system involvement by malignant disease. Subjects with&#xD;
             previously treated brain metastases may participate provided they are radiologically&#xD;
             stable, ie, are without evidence of progression for at least 4 weeks by repeat imaging&#xD;
             and are clinically stable and without requirement of steroid treatment for at least 14&#xD;
             days prior to first dose of study treatment.&#xD;
&#xD;
         11. Active known or suspected autoimmune disease&#xD;
&#xD;
         12. Receipt of an organ allograft&#xD;
&#xD;
         13. History or evidence of any other clinically unstable/uncontrolled disorder, condition,&#xD;
             or disease (including, but not limited to, cardiopulmonary, renal, metabolic,&#xD;
             hematologic or psychiatric) other than their primary malignancy, that in the opinion&#xD;
             of the Investigator would pose a risk to patient safety or interfere with study&#xD;
             evaluations, procedures, or completion&#xD;
&#xD;
         14. Treatment with antibiotics within 14 days prior to first dose of study drug&#xD;
&#xD;
         15. Receipt of a live-virus vaccine within 30 days prior to first dose of study drug&#xD;
             (seasonal flu vaccines that do not contain live virus are permitted).&#xD;
&#xD;
         16. Treatment with ipilimumab within 4 weeks of the start of study drug&#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>Ben Thompson, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Xencor, Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ben Thompson, MD, PhD</last_name>
    <phone>619 571-7381</phone>
    <email>bthompson@xencor.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Amber Sarot</last_name>
    <phone>858-245-9419</phone>
    <email>asarot@xencor.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UC San Diego Moores Cancer Center</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Colorado Hospital - Anschutz Cancer Pavilion</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sarah Cannon Research Institute at HealthONE</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine Siteman Cancer Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Duke Cancer Institute</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Providence Portland Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania Abramson Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>UPMC Hillman Cancer Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mary Crowley Cancer Research - Medical City</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Utah, Huntsman Cancer Institute</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Emily Couric Clinical Cancer Center</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Seattle Cancer Care Alliance</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>March 24, 2023</last_update_submitted>
  <last_update_submitted_qc>March 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>DUET-3</keyword>
  <keyword>Advanced solid tumors</keyword>
  <keyword>Melanoma</keyword>
  <keyword>Cervical Cancer</keyword>
  <keyword>Pancreatic Cancer</keyword>
  <keyword>Triple Negative Breast Cancer</keyword>
  <keyword>Hepatocellular/Liver Cancer</keyword>
  <keyword>Urothelial Cancer</keyword>
  <keyword>Bladder Cancer</keyword>
  <keyword>Renal Cell Cancer</keyword>
  <keyword>Head and Neck Cancer</keyword>
  <keyword>Colorectal Cancer</keyword>
  <keyword>Endometrial Cancer</keyword>
  <keyword>Non-small Cell Lung Cancer</keyword>
  <keyword>Small Cell Lung Cancer</keyword>
  <keyword>Gastric Cancer</keyword>
  <keyword>Gastroesophageal Junction Cancer</keyword>
  <keyword>Sarcoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Melanoma</mesh_term>
    <mesh_term>Sarcoma</mesh_term>
    <mesh_term>Small Cell Lung Carcinoma</mesh_term>
    <mesh_term>Nasopharyngeal Carcinoma</mesh_term>
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Endometrial Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Histiocytoma, Malignant Fibrous</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ipilimumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03752398
org study id: XmAb23104-01
secondary id: DUET-3
nct id: NCT03752398
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and
      regimen of XmAb23104, to describe safety and tolerability, to assess PK and immunogenicity,
      and to preliminarily assess anti-tumor activity of XmAb23104 monotherapy and combination
      therapy with ipilimumab in subjects with selected advanced solid tumors.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Treatment-related adverse events as assessed by CTCAE v4.03
time frame: 56 Days
description: Safety and tolerability
arm group label: XmAb®23104 Monotherapy
arm group type: Experimental
description: XmAb®23104 administered by IV dosing on Days 1 and 15 of each 28-day cycle x 2 cycles
arm group label: XmAb®23104 Combination Therapy with Ipilimumab
arm group type: Experimental
description: XmAb®23104 administered by IV on Days 1 and 15 of each 28-day cycle x 2 cycles + Yervoy® (ipilimumab)
intervention type: Biological
intervention name: XmAb®23104
description: Monoclonal bispecific antibody
arm group label: XmAb®23104 Combination Therapy with Ipilimumab
arm group label: XmAb®23104 Monotherapy
intervention type: Biological
intervention name: Yervoy® (ipilimumab)
description: Monoclonal antibody
arm group label: XmAb®23104 Combination Therapy with Ipilimumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ben Thompson, MD, PhD
role: Study Director
affiliation: Xencor, Inc.
last name: Ben Thompson, MD, PhD
phone: 619 571-7381
email: bthompson@xencor.com
last name: Amber Sarot
phone: 858-245-9419
email: asarot@xencor.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Lung Neoplasms
mesh term: Melanoma
mesh term: Sarcoma
mesh term: Small Cell Lung Carcinoma
mesh term: Nasopharyngeal Carcinoma
mesh term: Breast Neoplasms
mesh term: Squamous Cell Carcinoma of Head and Neck
mesh term: Colorectal Neoplasms
mesh term: Endometrial Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Pancreatic Neoplasms
mesh term: Histiocytoma, Malignant Fibrous
mesh term: Ipilimumab
sharing ipd: No