<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/NCT03783403</url>
  </required_header>
  <id_info>
    <org_study_id>CC-95251-ST-001</org_study_id>
    <secondary_id>U1111-1224-8251</secondary_id>
    <nct_id>NCT03783403</nct_id>
    <nct_alias>NCT03816254</nct_alias>
  </id_info>
  <brief_title>A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers</brief_title>
  <official_title>A Phase 1, Open-label, Dose Finding Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, Alone and in Combination With Cetuximab or Rituximab in Subjects With Advanced Solid and Hematologic Cancers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Celgene</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Celgene</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 evaluate the safety, tolerability, and preliminary clinical&#xD;
      activity of CC-95251 as a single agent and in combination with cetuximab and rituximab in&#xD;
      participants with advanced solid and hematologic cancers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">August 25, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 20, 2024</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>Non-Tolerated Dose (NTD): A dose that causes unacceptable side effects</measure>
    <time_frame>18 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Tolerated Dose (MTD): The highest dose that does not cause unacceptable side effects</measure>
    <time_frame>18 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Dose-Limiting Toxicity (DLT): Any adverse events meeting the protocol-defined DLT criteria</measure>
    <time_frame>30 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall response rate (ORR): The percent of participants whose best response is complete response (CR) or partial response (PR)</measure>
    <time_frame>72 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to response (TTR): Time from the first dose to the first objective tumor response observed for participants who achieved a CR or PR</measure>
    <time_frame>66 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DOR): Time from the first objective tumor response observed for participants who achieved a CR or PR until the first date at progressive disease is objectively documented</measure>
    <time_frame>66 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (PFS): Time from the first dose to the first occurrence of disease progression or death from any cause</measure>
    <time_frame>66 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS): Time from the first dose to death due to any cause</measure>
    <time_frame>66 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic - Maximum serum concentration of the drug (Cmax)</measure>
    <time_frame>36 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic - Minimum serum concentration of the drug (Cmin)</measure>
    <time_frame>36 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic - Area under the serum concentration time-curve of the drug (AUC)</measure>
    <time_frame>36 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-CC-95251 antibody (ADA) assessment: determine the presence and frequency of anti-drug antibodies</measure>
    <time_frame>36 Months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">230</enrollment>
  <condition>Neoplasms</condition>
  <arm_group>
    <arm_group_label>CC-95251</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>CC-95251 in combination with rituximab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>CC-95251 in combination with cetuximab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CC-95251</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>CC-95251</arm_group_label>
    <arm_group_label>CC-95251 in combination with cetuximab</arm_group_label>
    <arm_group_label>CC-95251 in combination with rituximab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>CC-95251 in combination with rituximab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cetuximab</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>CC-95251 in combination with cetuximab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Progressed on standard anticancer therapy or for whom no other approved conventional&#xD;
             therapy exists and have histological or cytological confirmation of advanced&#xD;
             unresectable solid tumors, advanced unresectable colorectal cancer, or squamous cell&#xD;
             carcinoma of the head and neck, or CD20-positive non-Hodgkin's lymphoma, or diffuse&#xD;
             large B cell lymphoma, or follicular lymphoma&#xD;
&#xD;
          -  Solid tumors must have at least one site of measurable disease as determined by RECIST&#xD;
             v1.1&#xD;
&#xD;
          -  Eastern cooperative oncology group performance status of 0 or 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  High-grade lymphomas (Burkitt's or lymphoblastic)&#xD;
&#xD;
          -  Has cancer with symptomatic central nervous system (CNS) involvement&#xD;
&#xD;
          -  History of class III or IV congestive heart failure (CHF) or severe non-ischemic&#xD;
             cardiomyopathy, unstable angina, myocardial infarction, or ventricular arrhythmia&#xD;
             within the previous 6 months&#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>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Local Institution - 105</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 101</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 112</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 115</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 110</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 109</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 106</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 113</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 107</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 102</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203-1625</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 108</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 103</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 301</name>
      <address>
        <city>Heidelberg</city>
        <state>Victoria</state>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 303</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 201</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 202</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 402</name>
      <address>
        <city>Borddeaux Cedex</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 406</name>
      <address>
        <city>Creteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 405</name>
      <address>
        <city>Marseille</city>
        <zip>13009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 404</name>
      <address>
        <city>Nantes Cedex 01</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 403</name>
      <address>
        <city>Rouen</city>
        <zip>76038</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 401</name>
      <address>
        <city>Villejuif CEDEX</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 701</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 702</name>
      <address>
        <city>Napoli, Campania</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 604</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 603</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 602</name>
      <address>
        <city>Seoul</city>
        <zip>3080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 601</name>
      <address>
        <city>Seoul</city>
        <zip>5505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 504</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 502</name>
      <address>
        <city>Malaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 501</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 802</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>France</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>BMS Clinical Trial Information</description>
  </link>
  <link>
    <url>http://www.BMSStudyConnect.com</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <link>
    <url>http://www.fda.gov/safety/medwatch/safetyinformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>July 28, 2023</last_update_submitted>
  <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Antibody</keyword>
  <keyword>CC-95251</keyword>
  <keyword>SIRPα</keyword>
  <keyword>Advanced Solid Cancers</keyword>
  <keyword>Advanced Hematologic Cancers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematologic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rituximab</mesh_term>
    <mesh_term>Cetuximab</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/NCT03783403
org study id: CC-95251-ST-001
secondary id: U1111-1224-8251
nct id: NCT03783403
nct alias: NCT03816254
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the safety, tolerability, and preliminary clinical
      activity of CC-95251 as a single agent and in combination with cetuximab and rituximab in
      participants with advanced solid and hematologic cancers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Non-Tolerated Dose (NTD): A dose that causes unacceptable side effects
time frame: 18 months
measure: Maximum Tolerated Dose (MTD): The highest dose that does not cause unacceptable side effects
time frame: 18 months
measure: Dose-Limiting Toxicity (DLT): Any adverse events meeting the protocol-defined DLT criteria
time frame: 30 months
measure: Overall response rate (ORR): The percent of participants whose best response is complete response (CR) or partial response (PR)
time frame: 72 Months
measure: Time to response (TTR): Time from the first dose to the first objective tumor response observed for participants who achieved a CR or PR
time frame: 66 Months
measure: Duration of response (DOR): Time from the first objective tumor response observed for participants who achieved a CR or PR until the first date at progressive disease is objectively documented
time frame: 66 Months
measure: Progression free survival (PFS): Time from the first dose to the first occurrence of disease progression or death from any cause
time frame: 66 Months
measure: Overall survival (OS): Time from the first dose to death due to any cause
time frame: 66 Months
measure: Pharmacokinetic - Maximum serum concentration of the drug (Cmax)
time frame: 36 Months
measure: Pharmacokinetic - Minimum serum concentration of the drug (Cmin)
time frame: 36 Months
measure: Pharmacokinetic - Area under the serum concentration time-curve of the drug (AUC)
time frame: 36 Months
measure: Anti-CC-95251 antibody (ADA) assessment: determine the presence and frequency of anti-drug antibodies
time frame: 36 Months
arm group label: CC-95251
arm group type: Experimental
arm group label: CC-95251 in combination with rituximab
arm group type: Experimental
arm group label: CC-95251 in combination with cetuximab
arm group type: Experimental
intervention type: Drug
intervention name: CC-95251
description: Specified dose on specified days
arm group label: CC-95251
arm group label: CC-95251 in combination with cetuximab
arm group label: CC-95251 in combination with rituximab
intervention type: Drug
intervention name: Rituximab
description: Specified dose on specified days
arm group label: CC-95251 in combination with rituximab
intervention type: Drug
intervention name: Cetuximab
description: Specified dose on specified days
arm group label: CC-95251 in combination with cetuximab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
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country: Australia
country: Canada
country: France
country: Italy
country: Korea, Republic of
country: Spain
country: United Kingdom
country: United States
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: http://www.BMSStudyConnect.com
description: BMS Clinical Trial Patient Recruiting
url: http://www.fda.gov/safety/medwatch/safetyinformation/default.htm
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor
mesh term: Hematologic Neoplasms
mesh term: Rituximab
mesh term: Cetuximab