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/NCT05996445</url>
    </required_header>
    <id_info>
      <org_study_id>XmAb662-01</org_study_id>
      <nct_id>NCT05996445</nct_id>
    </id_info>
    <brief_title>A Study of XmAb®662 as Monotherapy or in Combination With Pembrolizumab in Advanced Solid Tumors</brief_title>
    <official_title>A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®662 in Monotherapy or in Combination With Pembrolizumab in Advanced Solid Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Xencor, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </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>
        The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of&#xD;
        intravenous administration of XmAb662 monotherapy or in combination with pembrolizumab in&#xD;
        subjects with advanced solid tumors and to identify the recommended dose regimen that is safe&#xD;
        and biologically effective for XmAb662.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a first-in-human (FIH), Phase 1, open-label, multicenter dose escalation study with&#xD;
        cohort expansion at one or more recommended dose(s) (RDs), designed to evaluate the safety&#xD;
        and tolerability of XmAb662 monotherapy or in combination with pembrolizumab in subjects with&#xD;
        selected solid tumors that have progressed after standard/approved therapies, or for which&#xD;
        there are no effective available therapies. This study will be conducted in 2 parts: dose&#xD;
        escalation (Part 1) and dose expansion (Part 2), and subdivided into arms for XmAb662&#xD;
        monotherapy and XmAb662+pembrolizumab combination.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 28, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2030</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2028</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <intervention_model_description>Sequential Assignments</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of dose-limiting toxicities (DLTs)</measure>
      <time_frame>First 3 weeks on treatment for each subject]</time_frame>
      <description>Safety and tolerability as assessed by incidence of DLTs and all available data which will be used to determine the recommend dose(s)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence and severity of treatment emergent adverse events (TEAEs)</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Safety and tolerability as assessed by incidence of TEAEs, including clinically significant changes in safety laboratory tests and clinical findings</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Characterization of pharmacokinetics</measure>
      <time_frame>56 Days</time_frame>
      <description>Measurement of Cmax</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Characterization of pharmacokinetics</measure>
      <time_frame>56 Days</time_frame>
      <description>Measurement of AUC</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective response rate</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Objective response rate by RECIST 1.1, as modified by PCWG3 for participants with prostate cancer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Progression-free survival by RECIST 1.1, as modified by PCWG3 for participants with prostate cancer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Duration of response by RECIST 1.1, as modified by PCWG3 for participants with prostate cancer</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">210</enrollment>
    <condition>Solid Tumors</condition>
    <arm_group>
      <arm_group_label>Dose Escalation and Expansion XmAb662 administered as monotherapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Dose Escalation and Expansion XmAb662 administered in combination with pembrolizumbab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>XmAb662</intervention_name>
      <description>Intravenous (IV) administration</description>
      <arm_group_label>Dose Escalation and Expansion XmAb662 administered as monotherapy</arm_group_label>
      <arm_group_label>Dose Escalation and Expansion XmAb662 administered in combination with pembrolizumbab</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Keytruda® (pembrolizumab)</intervention_name>
      <description>Intravenous (IV) administration</description>
      <arm_group_label>Dose Escalation and Expansion XmAb662 administered in combination with pembrolizumbab</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Advanced, recurrent or metastatic solid malignancy that is not amenable to curative-intent&#xD;
          treatment and which has progressed after standard therapy appropriate for the following&#xD;
          tumor type: Head and neck squamous cell carcinoma, melanoma, non-small cell lung cancer,&#xD;
          small cell lung cancer (SCLC), urothelial carcinoma, colorectal cancer, gastric cancer,&#xD;
          esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal&#xD;
          cell carcinoma, endometrial cancer, cutaneous squamous cell carcinoma, breast cancer,&#xD;
          ovarian cancer (epithelial), castration-resistant prostate cancer (adenocarcinoma)&#xD;
  &#xD;
          Measurable disease by RECIST 1.1; subjects with prostate cancer who have evaluable disease&#xD;
          according to PCWG3 criteria may enroll&#xD;
  &#xD;
          Life expectancy of at least 3 months&#xD;
  &#xD;
          Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2&#xD;
  &#xD;
          For dose escalation cohorts, subjects must have adequate archival tumor sample or willing&#xD;
          to provide a fresh tumor&#xD;
  &#xD;
          Adequate organ function&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Receiving treatment with the following therapies: Interleukin (IL)-12 either alone or as&#xD;
          part of a treatment regimen; checkpoint inhibitors given within 4 weeks of study drug;&#xD;
          other anticancer therapies, including chemotherapy or radiation therapy, given within 4&#xD;
          weeks of the start of study drug (palliative radiation given within a 1-week washout is&#xD;
          allowed)&#xD;
  &#xD;
          History of allergic or anaphylactic/hypersensitivity reaction to immunotherapy&#xD;
  &#xD;
          History of a life-threatening (Grade 4) immune-related adverse event (irAE) related to&#xD;
          prior immunotherapy or any prior irAE, regardless of grade&#xD;
  &#xD;
          History or evidence of any clinically unstable/uncontrolled disorder, condition, or disease&#xD;
          (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic, or&#xD;
          psychiatric) other than their primary malignancy&#xD;
  &#xD;
          Known active central nervous system involvement by malignant disease; subjects with&#xD;
          previously treated brain metastases may participate provided they are radiologically and&#xD;
          clinically stable&#xD;
  &#xD;
          For subjects receiving pembrolizumab, prior Grade 3 or Grade 4 infusion-related reactions&#xD;
          to pembrolizumab, or known hypersensitivity to pembrolizumab&#xD;
  &#xD;
          Other protocol defined inclusion/exclusion criteria apply&#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>Chet Bohac, MD</last_name>
      <role>Study Director</role>
      <affiliation>Executive Medical Director, Clinical Development</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Benjamin Thompson, MD, PhD</last_name>
      <phone>619-517-7381</phone>
      <email>bthompson@xencor.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ines Hoffmann</last_name>
      <phone>619- 994-8161</phone>
      <email>ihoffmann@xencor.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University Of Virginia Comprehensive Cancer Center</name>
        <address>
          <city>Charlottesville</city>
          <state>Virginia</state>
          <zip>22903</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>IL-12,</keyword>
    <keyword>interleukin-12</keyword>
    <keyword>pembrolizumab</keyword>
    <keyword>Advanced Solid Tumors</keyword>
    <keyword>Metastatic Solid Tumors</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pembrolizumab</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/NCT05996445
  org study id: XmAb662-01
  nct id: NCT05996445
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
        intravenous administration of XmAb662 monotherapy or in combination with pembrolizumab in
        subjects with advanced solid tumors and to identify the recommended dose regimen that is safe
        and biologically effective for XmAb662.
  This is a first-in-human (FIH), Phase 1, open-label, multicenter dose escalation study with
        cohort expansion at one or more recommended dose(s) (RDs), designed to evaluate the safety
        and tolerability of XmAb662 monotherapy or in combination with pembrolizumab in subjects with
        selected solid tumors that have progressed after standard/approved therapies, or for which
        there are no effective available therapies. This study will be conducted in 2 parts: dose
        escalation (Part 1) and dose expansion (Part 2), and subdivided into arms for XmAb662
        monotherapy and XmAb662+pembrolizumab combination.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  intervention model description: Sequential Assignments
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence of dose-limiting toxicities (DLTs)
  time frame: First 3 weeks on treatment for each subject]
  description: Safety and tolerability as assessed by incidence of DLTs and all available data which will be used to determine the recommend dose(s)
  measure: Incidence and severity of treatment emergent adverse events (TEAEs)
  time frame: Up to 2 years
  description: Safety and tolerability as assessed by incidence of TEAEs, including clinically significant changes in safety laboratory tests and clinical findings
  measure: Characterization of pharmacokinetics
  time frame: 56 Days
  description: Measurement of Cmax
  measure: Characterization of pharmacokinetics
  time frame: 56 Days
  description: Measurement of AUC
  measure: Objective response rate
  time frame: Up to 2 years
  description: Objective response rate by RECIST 1.1, as modified by PCWG3 for participants with prostate cancer
  measure: Progression-free survival
  time frame: Up to 2 years
  description: Progression-free survival by RECIST 1.1, as modified by PCWG3 for participants with prostate cancer
  measure: Duration of response
  time frame: Up to 2 years
  description: Duration of response by RECIST 1.1, as modified by PCWG3 for participants with prostate cancer
  arm group label: Dose Escalation and Expansion XmAb662 administered as monotherapy
  arm group type: Experimental
  arm group label: Dose Escalation and Expansion XmAb662 administered in combination with pembrolizumbab
  arm group type: Experimental
  intervention type: Biological
  intervention name: XmAb662
  description: Intravenous (IV) administration
  arm group label: Dose Escalation and Expansion XmAb662 administered as monotherapy
  arm group label: Dose Escalation and Expansion XmAb662 administered in combination with pembrolizumbab
  intervention type: Biological
  intervention name: Keytruda® (pembrolizumab)
  description: Intravenous (IV) administration
  arm group label: Dose Escalation and Expansion XmAb662 administered in combination with pembrolizumbab
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Chet Bohac, MD
  role: Study Director
  affiliation: Executive Medical Director, Clinical Development
  last name: Benjamin Thompson, MD, PhD
  phone: 619-517-7381
  email: bthompson@xencor.com
  last name: Ines Hoffmann
  phone: 619- 994-8161
  email: ihoffmann@xencor.com
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  mesh term: Neoplasms
  mesh term: Pembrolizumab