<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/NCT03295942</url>
  </required_header>
  <id_info>
    <org_study_id>336B11-001</org_study_id>
    <nct_id>NCT03295942</nct_id>
  </id_info>
  <brief_title>A Study of OMP-336B11 in Subjects With Locally Advanced or Metastatic Tumors</brief_title>
  <official_title>A Phase 1a Open-Label, Dose Escalation Study of the Safety and Pharmacokinetics of OMP-336B11 Administered as a Single Agent to Subjects With Locally Advanced or Metastatic Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OncoMed Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mereo BioPharma</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>
      The purpose of this study is to test the safety and efficacy of OMP-336B11. OMP-336B11 is an&#xD;
      engineered human protein that was designed to bind to the GITR receptor on T cells and&#xD;
      activate the immune system to recognize and eliminate cancer cells.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, Phase 1a dose escalation study of OMP-336B11 administered as a single&#xD;
      agent to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics in patients&#xD;
      with locally advanced or metastatic tumors. This study consists of a screening period, a&#xD;
      treatment period, and a post-treatment follow-up period in which patients will be followed&#xD;
      for survival for up to approximately 2 years. Patients will be enrolled in two stages: a&#xD;
      dose-escalation stage and an expansion phase.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor decision&#xD;
  </why_stopped>
  <start_date type="Actual">September 12, 2017</start_date>
  <completion_date type="Actual">July 4, 2019</completion_date>
  <primary_completion_date type="Actual">July 4, 2019</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>
    <intervention_model_description>OMP-336B11</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with OMP-336B11</measure>
    <time_frame>Subjects will be assessed for DLTs through the end of the first cycle (Days 1-29)</time_frame>
    <description>Incidence of dose limiting toxicities (DLTs)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Outcome Measures (CL)</measure>
    <time_frame>Screening through 12 weeks post treatment termination</time_frame>
    <description>Clearance (CL) will be evaluated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Outcome Measures (Vd)</measure>
    <time_frame>Screening through 12 weeks post treatment termination</time_frame>
    <description>Volume of distribution (Vd) will be evaluated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Outcome Measures (T1/2)</measure>
    <time_frame>Screening through 12 weeks post treatment termination</time_frame>
    <description>The half life (T1/2) of OMP-336B11 will be assessed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity of OMP-336B11 (Percentage of patients with anti-336B11 antibodies)</measure>
    <time_frame>up to approximately 2 years</time_frame>
    <description>Percentage of patients with anti-336B11 antibodies assessed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response</measure>
    <time_frame>up to approximately 2 years</time_frame>
    <description>Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival</measure>
    <time_frame>up to approximately 2 years</time_frame>
    <description>Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Locally Advanced Malignant Neoplasm</condition>
  <condition>Metastatic Cancer</condition>
  <arm_group>
    <arm_group_label>OMP-336B11</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous (in the vein) infusions of OMP-336B11</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OMP-336B11</intervention_name>
    <description>OMP-336B11 is an engineered human protein that was designed to bind to the GITR receptor on T cells and activate the immune system to recognize and eliminate cancer cells.</description>
    <arm_group_label>OMP-336B11</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Locally advanced or metastatic solid tumors that have exhausted standard of care&#xD;
             therapy&#xD;
&#xD;
          -  Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1&#xD;
&#xD;
          -  Age &gt;21 years&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1&#xD;
&#xD;
          -  Adequate organ and marrow function&#xD;
&#xD;
          -  For women of childbearing potential and men with partners of childbearing potential,&#xD;
             agreement (by patient and/or partner) to use two effective forms of contraception from&#xD;
             study entry through at least 6 months after the termination visit.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Receiving any other investigational agents or any other anti-cancer therapy&#xD;
&#xD;
          -  Active autoimmune disease or a history of severe autoimmune disease or syndrome&#xD;
&#xD;
          -  History of severe allergic, anaphylactic, or other hypersensitivity reactions to&#xD;
             chimeric or humanized antibodies or fusion proteins&#xD;
&#xD;
          -  Pregnancy, lactating or breastfeeding women&#xD;
&#xD;
          -  History of primary CNS malignancy, or leptomeningeal disease or CNS metastases&#xD;
&#xD;
          -  Significant uncontrolled intercurrent illness that will limit the patient's ability to&#xD;
             participate in the study&#xD;
&#xD;
          -  Inability to comply with study and follow up procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kyriakos P Papadopoulos, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>South Texas Accelerated Research Therapeutics, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>South Texas Accelerated Research Therapeutics, LLC</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>August 10, 2020</last_update_submitted>
  <last_update_submitted_qc>August 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_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/NCT03295942
org study id: 336B11-001
nct id: NCT03295942
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to test the safety and efficacy of OMP-336B11. OMP-336B11 is an
      engineered human protein that was designed to bind to the GITR receptor on T cells and
      activate the immune system to recognize and eliminate cancer cells.
This is an open-label, Phase 1a dose escalation study of OMP-336B11 administered as a single
      agent to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics in patients
      with locally advanced or metastatic tumors. This study consists of a screening period, a
      treatment period, and a post-treatment follow-up period in which patients will be followed
      for survival for up to approximately 2 years. Patients will be enrolled in two stages: a
      dose-escalation stage and an expansion phase.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: OMP-336B11
primary purpose: Treatment
masking: None (Open Label)
measure: The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with OMP-336B11
time frame: Subjects will be assessed for DLTs through the end of the first cycle (Days 1-29)
description: Incidence of dose limiting toxicities (DLTs)
measure: Pharmacokinetic Outcome Measures (CL)
time frame: Screening through 12 weeks post treatment termination
description: Clearance (CL) will be evaluated
measure: Pharmacokinetic Outcome Measures (Vd)
time frame: Screening through 12 weeks post treatment termination
description: Volume of distribution (Vd) will be evaluated
measure: Pharmacokinetic Outcome Measures (T1/2)
time frame: Screening through 12 weeks post treatment termination
description: The half life (T1/2) of OMP-336B11 will be assessed
measure: Immunogenicity of OMP-336B11 (Percentage of patients with anti-336B11 antibodies)
time frame: up to approximately 2 years
description: Percentage of patients with anti-336B11 antibodies assessed
measure: Objective Response
time frame: up to approximately 2 years
description: Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
measure: Progression-Free Survival
time frame: up to approximately 2 years
description: Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
arm group label: OMP-336B11
arm group type: Experimental
description: Intravenous (in the vein) infusions of OMP-336B11
intervention type: Drug
intervention name: OMP-336B11
description: OMP-336B11 is an engineered human protein that was designed to bind to the GITR receptor on T cells and activate the immune system to recognize and eliminate cancer cells.
arm group label: OMP-336B11
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Kyriakos P Papadopoulos, MD
role: Principal Investigator
affiliation: South Texas Accelerated Research Therapeutics, LLC
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: No