<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/NCT03031691</url>
  </required_header>
  <id_info>
    <org_study_id>52M51-003</org_study_id>
    <nct_id>NCT03031691</nct_id>
  </id_info>
  <brief_title>A Study of Brontictuzumab With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal Cancer</brief_title>
  <official_title>A Phase 1b Dose Escalation Study of the Safety and Pharmacodynamics of Brontictuzumab in Combination With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal Cancer</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Phase 1b Dose Escalation Study of the Safety and Pharmacodynamics of Brontictuzumab in&#xD;
      Combination with Chemotherapy for Subjects with Previously Treated Metastatic Colorectal&#xD;
      Cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase 1b dose escalation study of the safety and pharmacodynamics of brontictuzumab&#xD;
      in combination with chemotherapy for subjects with previously treated metastatic colorectal&#xD;
      cancer. This study consists of a screening period, a treatment period and a post-treatment&#xD;
      follow up period in which patients will be followed for survival for up to 24 months.&#xD;
      Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase.&#xD;
&#xD;
      Approximately 34 patients will be enrolled in this study at approximately 5 study centers in&#xD;
      the United States.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">May 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>Percentage of patients with adverse events</measure>
    <time_frame>up to approximately 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients with dose limiting toxicities</measure>
    <time_frame>28 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients with anti-brontictuzumab antibodies</measure>
    <time_frame>up to approximately 2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)</measure>
    <time_frame>approximately 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1</measure>
    <time_frame>approximately 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in number of circulating tumor cells</measure>
    <time_frame>approximately 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>approximately 2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Metastatic Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Brontictuzumab and trifluridine/tipiracil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Brontictuzumab will be administered per protocol and trifluridine/tipiracil per label.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>brontictuzumab</intervention_name>
    <description>starting dose of 1.5mg/kg administered intravenously (IV)</description>
    <arm_group_label>Brontictuzumab and trifluridine/tipiracil</arm_group_label>
    <other_name>OMP-52M51</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>trifluridine/tipiracil</intervention_name>
    <arm_group_label>Brontictuzumab and trifluridine/tipiracil</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed metastatic colorectal cancer (mCRC) previously treated with&#xD;
             fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF&#xD;
             biological therapy, and if KRAS wild-type, an anti-EGFR therapy&#xD;
&#xD;
          -  ECOG performance status 0 or 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment with gamma secretase inhibitors or other Notch 1 inhibitors&#xD;
&#xD;
          -  Subjects with known active HIV infection. Subjects with HIV that are under a stable&#xD;
             anti-retroviral regimen and have no evidence of immune deficiency (normal CD4 counts),&#xD;
             undetectable viral load, and no HIV-related infections are eligible&#xD;
&#xD;
          -  Subjects with uncontrolled diarrhea &lt;30 days prior to first administration of study&#xD;
             drug&#xD;
&#xD;
          -  Subjects with any history of or current clinically significant gastrointestinal&#xD;
             disease including, but not limited to:&#xD;
&#xD;
               -  Inflammatory bowel disease (including ulcerative colitis and Crohn's disease)&#xD;
&#xD;
               -  Active peptic ulcer disease&#xD;
&#xD;
               -  Known intraluminal metastatic lesion(s) with risk of bleeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Denver</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarasota</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charleston</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nashville</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 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>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trifluridine</mesh_term>
  </intervention_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/NCT03031691
org study id: 52M51-003
nct id: NCT03031691
lead sponsor: 
has dmc: No
A Phase 1b Dose Escalation Study of the Safety and Pharmacodynamics of Brontictuzumab in
      Combination with Chemotherapy for Subjects with Previously Treated Metastatic Colorectal
      Cancer.
This is a phase 1b dose escalation study of the safety and pharmacodynamics of brontictuzumab
      in combination with chemotherapy for subjects with previously treated metastatic colorectal
      cancer. 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 24 months.
      Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase.

      Approximately 34 patients will be enrolled in this study at approximately 5 study centers in
      the United States.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of patients with adverse events
time frame: up to approximately 2 years
measure: Percentage of patients with dose limiting toxicities
time frame: 28 days
measure: Percentage of patients with anti-brontictuzumab antibodies
time frame: up to approximately 2 years
measure: Objective Response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
time frame: approximately 2 years
measure: Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1
time frame: approximately 2 years
measure: Changes in number of circulating tumor cells
time frame: approximately 2 years
measure: Overall survival
time frame: approximately 2 years
arm group label: Brontictuzumab and trifluridine/tipiracil
arm group type: Experimental
description: Brontictuzumab will be administered per protocol and trifluridine/tipiracil per label.
intervention type: Drug
intervention name: brontictuzumab
description: starting dose of 1.5mg/kg administered intravenously (IV)
arm group label: Brontictuzumab and trifluridine/tipiracil
other name: OMP-52M51
intervention type: Drug
intervention name: trifluridine/tipiracil
arm group label: Brontictuzumab and trifluridine/tipiracil
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Trifluridine