<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/NCT03035253</url>
  </required_header>
  <id_info>
    <org_study_id>B83-003</org_study_id>
    <nct_id>NCT03035253</nct_id>
  </id_info>
  <brief_title>A Study of OMP-305B83 in Subjects With Metastatic Colorectal Cancer</brief_title>
  <official_title>A Phase 1b Study of OMP-305B83 Plus FOLFIRI or FOLFOX as Second Line Therapy in Subjects With 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>
  <brief_summary>
    <textblock>
      The purpose of this study is to test the safety and efficacy of an experimental drug,&#xD;
      OMP-305B83, when given in combination with FOLFIRI or FOLFOX. OMP-305B83 is a humanized&#xD;
      bispecific monoclonal antibody and was developed to target cancer stem cells. Based on&#xD;
      preclinical studies, it is believed that OMP-305B83 may block the growth of cancer stem cells&#xD;
      and may also impair the productive growth of new blood vessels, which tumors need to grow and&#xD;
      spread.&#xD;
&#xD;
      The study is sponsored by OncoMed Pharmaceuticals, which is referred to as OncoMed or the&#xD;
      Sponsor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, Phase 1b dose escalation and expansion study of OMP-305B83 plus&#xD;
      FOLFIRI or FOLFOX to evaluate the safety, efficacy, and pharmacokinetics of OMP-305B83 in&#xD;
      combination with FOLFIRI or FOLFOX in patients with metastatic Colorectal Cancer. This study&#xD;
      consists of a screening period, a treatment period, and a post-treatment follow-up period in&#xD;
      which patients will be followed for survival for up to 5 years. Patients will be enrolled in&#xD;
      two stages: a dose-escalation stage and an expansion phase.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">September 2018</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 dose limiting toxicities</measure>
    <time_frame>Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28).</time_frame>
    <description>The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with OMP-305B83 in combination with FOLFIRI or FOLFOX</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety of OMP-305B83 in combination with FOLFIRI or FOLFOX will be assessed by adverse event monitoring, physical exams, vital signs, clinical laboratory testing, ECGs, echocardiograms, anti-OMP-305B83 testing, and subject interview on an ongoing basis.</measure>
    <time_frame>Through study completion, an average of 8 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity (in terms of formation of anti-drug antibod(ies) against OMP-305B83 in percentage of subjects) of OMP-305B83 in combination with FOLFIRI or FOLFOX</measure>
    <time_frame>Through study completion, an average of 8 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response Rate assessed by RECIST criteria 1.1</measure>
    <time_frame>At 56 day intervals while on treatment, through study completion, an average of 8 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response Rate assessed by tumor marker CEA</measure>
    <time_frame>At 28 day intervals while on treatment, through study completion, an average of 8 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Metastatic Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>OMP-305B83 combined with FOLFIRI or FOLFOX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OMP-305B83</intervention_name>
    <arm_group_label>OMP-305B83 combined with FOLFIRI or FOLFOX</arm_group_label>
    <other_name>bispecific monoclonal antibody</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FOLFIRI</intervention_name>
    <description>Treatment will consist of OMP-305B83 and the FOLFIRI chemotherapy regimen.</description>
    <arm_group_label>OMP-305B83 combined with FOLFIRI or FOLFOX</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FOLFOX</intervention_name>
    <description>Treatment will consist of OMP-305B83 and the FOLFOX chemotherapy regimen.</description>
    <arm_group_label>OMP-305B83 combined with FOLFIRI or FOLFOX</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#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;
          -  Receiving prior hepatic intra-arterial chemotherapy&#xD;
&#xD;
          -  Known significant clinically significant gastrointestinal disease&#xD;
&#xD;
          -  Patients with brain metastases (treated or untreated) leptomeningeal disease,&#xD;
             uncontrolled seizure disorder, or active neurologic disease&#xD;
&#xD;
          -  Significant intercurrent illness that will limit the patient's ability to participate&#xD;
             in the study or may result in their death over the next 18 months&#xD;
&#xD;
          -  Pregnant or nursing women&#xD;
&#xD;
          -  Inability to comply with study and follow up procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>City of Hope National Medical Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Care &amp; Hematology - Fort Collins</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80528</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan Health System</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109-2800</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </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>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 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>Antibodies, Bispecific</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/NCT03035253
org study id: B83-003
nct id: NCT03035253
lead sponsor: 
The purpose of this study is to test the safety and efficacy of an experimental drug,
      OMP-305B83, when given in combination with FOLFIRI or FOLFOX. OMP-305B83 is a humanized
      bispecific monoclonal antibody and was developed to target cancer stem cells. Based on
      preclinical studies, it is believed that OMP-305B83 may block the growth of cancer stem cells
      and may also impair the productive growth of new blood vessels, which tumors need to grow and
      spread.

      The study is sponsored by OncoMed Pharmaceuticals, which is referred to as OncoMed or the
      Sponsor.
This is an open-label, Phase 1b dose escalation and expansion study of OMP-305B83 plus
      FOLFIRI or FOLFOX to evaluate the safety, efficacy, and pharmacokinetics of OMP-305B83 in
      combination with FOLFIRI or FOLFOX in patients with 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 5 years. Patients will be enrolled in
      two stages: a dose-escalation stage and an expansion phase.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of dose limiting toxicities
time frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28).
description: The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with OMP-305B83 in combination with FOLFIRI or FOLFOX
measure: Safety of OMP-305B83 in combination with FOLFIRI or FOLFOX will be assessed by adverse event monitoring, physical exams, vital signs, clinical laboratory testing, ECGs, echocardiograms, anti-OMP-305B83 testing, and subject interview on an ongoing basis.
time frame: Through study completion, an average of 8 months
measure: Immunogenicity (in terms of formation of anti-drug antibod(ies) against OMP-305B83 in percentage of subjects) of OMP-305B83 in combination with FOLFIRI or FOLFOX
time frame: Through study completion, an average of 8 months
measure: Response Rate assessed by RECIST criteria 1.1
time frame: At 56 day intervals while on treatment, through study completion, an average of 8 months
measure: Response Rate assessed by tumor marker CEA
time frame: At 28 day intervals while on treatment, through study completion, an average of 8 months
measure: Progression Free Survival
time frame: Up to 5 years
arm group label: OMP-305B83 combined with FOLFIRI or FOLFOX
arm group type: Experimental
intervention type: Drug
intervention name: OMP-305B83
arm group label: OMP-305B83 combined with FOLFIRI or FOLFOX
other name: bispecific monoclonal antibody
intervention type: Drug
intervention name: FOLFIRI
description: Treatment will consist of OMP-305B83 and the FOLFIRI chemotherapy regimen.
arm group label: OMP-305B83 combined with FOLFIRI or FOLFOX
intervention type: Drug
intervention name: FOLFOX
description: Treatment will consist of OMP-305B83 and the FOLFOX chemotherapy regimen.
arm group label: OMP-305B83 combined with FOLFIRI or FOLFOX
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Antibodies, Bispecific