<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/NCT02216409</url>
  </required_header>
  <id_info>
    <org_study_id>SCI-CD47-001</org_study_id>
    <nct_id>NCT02216409</nct_id>
  </id_info>
  <brief_title>Phase 1 Trial of Hu5F9-G4, a CD47-targeting Antibody</brief_title>
  <official_title>A First-in-Human Phase 1 Dose Escalation Trial of Hu5F9-G4 in Patients With Advanced Solid Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gilead Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety and tolerability of Hu5F9-G4 in&#xD;
      participants with solid tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a first-in-human, first-in-class, escalating dose trial of an antibody that inhibits&#xD;
      an anti-apoptotic signal in human macrophages. The major aims of the study are to define the&#xD;
      safety profile of this new drug, and to determine a recommended dose and schedule for&#xD;
      potential additional trials.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">October 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>Safety and Tolerability of Hu5F9-G4</measure>
    <time_frame>The first 28 days on study, for determination of Dose Limiting Toxicities</time_frame>
    <description>The CTCAE criteria will be used to assess adverse events on this trial.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Solid Tumor</condition>
  <arm_group>
    <arm_group_label>Treatment (Hu5F9-G4)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hu5F9-G4 monotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hu5F9-G4</intervention_name>
    <arm_group_label>Treatment (Hu5F9-G4)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with histologically or cytologically confirmed advanced solid malignancy or&#xD;
        Lymphoma&#xD;
&#xD;
        Relapsed or refractory disease after at least 1 prior systemic treatment for the primary&#xD;
        malignancy and not a candidate for other curative treatment.&#xD;
&#xD;
        Adequate hematologic status&#xD;
&#xD;
        Adequate coagulation function&#xD;
&#xD;
        Adequate hepatic function&#xD;
&#xD;
        Adequate renal function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Known primary tumors of central nervous system disease&#xD;
&#xD;
        Known active brain metastases&#xD;
&#xD;
        Known cardiopulmonary disease&#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>Chris Takimoto, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Gilead Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford Cancer Institute</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>START Midwest</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan-Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Oklahoma</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Texas Accelerated Research Therapeutics</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>February 2019</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>February 1, 2019</last_update_submitted>
  <last_update_submitted_qc>February 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Magrolimab</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/NCT02216409
org study id: SCI-CD47-001
nct id: NCT02216409
lead sponsor: 
has dmc: No
The purpose of this study is to assess the safety and tolerability of Hu5F9-G4 in
      participants with solid tumors.
This is a first-in-human, first-in-class, escalating dose trial of an antibody that inhibits
      an anti-apoptotic signal in human macrophages. The major aims of the study are to define the
      safety profile of this new drug, and to determine a recommended dose and schedule for
      potential additional trials.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety and Tolerability of Hu5F9-G4
time frame: The first 28 days on study, for determination of Dose Limiting Toxicities
description: The CTCAE criteria will be used to assess adverse events on this trial.
arm group label: Treatment (Hu5F9-G4)
arm group type: Experimental
description: Hu5F9-G4 monotherapy
intervention type: Drug
intervention name: Hu5F9-G4
arm group label: Treatment (Hu5F9-G4)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chris Takimoto, MD
role: Study Chair
affiliation: Gilead Sciences
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Magrolimab