<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/NCT02987504</url>
  </required_header>
  <id_info>
    <org_study_id>ALXN6000-ONC-102</org_study_id>
    <nct_id>NCT02987504</nct_id>
  </id_info>
  <brief_title>Study of Samalizumab in Patients With Advanced Cancer</brief_title>
  <official_title>A Multicenter, Dose-Escalation, Phase 1 Study of Samalizumab (ALXN6000) to Evaluate the Pharmacokinetics, Safety, and Tolerability in Patients With Advanced Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alexion</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Quintiles, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Alexion</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter, open-label, dose-escalation, Phase 1 study of intravenous (IV)&#xD;
      samalizumab to determine its maximum tolerated dose (MTD), overall safety/tolerability,&#xD;
      pharmacokinetic and pharmacodynamic parameters, and efficacy in participants with advanced&#xD;
      cancer. The study was terminated for administrative reasons and not due to any safety&#xD;
      concerns.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date type="Actual">November 17, 2016</start_date>
  <completion_date type="Actual">September 27, 2017</completion_date>
  <primary_completion_date type="Actual">September 12, 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>Number Of Participants Experiencing DLT Graded According To CTCAE Version 4.03, Observed In The Cycle 1 In Order To Meet The Objective Of Assessment Of The MTD</measure>
    <time_frame>Safety monitoring began at the informed consent obtained and continued up to 28 days after the last dose of samalizumab or until new anti-tumor therapy, whichever was earlier.</time_frame>
    <description>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Plasma Concentration After Administration Of Samalizumab</measure>
    <time_frame>21 days in Cycle 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under The Plasma Drug Concentration-time Curve After Administration Of Samalizumab</measure>
    <time_frame>21 days in Cycle 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate Using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1</measure>
    <time_frame>Up to 2 Years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate Using RECIST 1.1</measure>
    <time_frame>Up to 2 Years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration Of Response</measure>
    <time_frame>Up to 2 Years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>Up to 2 Years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>Up to last participant completing at least 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Advanced Solid Tumors</condition>
  <arm_group>
    <arm_group_label>Samalizumab 10, 15, 20 milligrams (mg)/kilogram (kg) Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received escalating doses of 10, 15, and 20 mg/kg of samalizumab IV every 21 days. Enrollment at each dose level and safety assessments were completed prior to enrolling at the next dose level; intra-participant dose escalation was not allowed.&#xD;
3 participants were enrolled into a dose cohort: If 0/3 participants developed dose limiting toxicities (DLT) within Cycle 1, enrollment began at the next higher dose to a maximum of 20 mg/kg. If 1/3 participants developed a DLT, the dose cohort was expanded to include 3 new participants. If 0/3 new participants developed a DLT within Cycle 1, enrolment began at the next higher dose level. If ≥1 of 3 new participants developed a DLT within Cycle 1, dose-escalation was terminated, and the dose level 5 mg/kg below the current dose was considered the MTD. If ≥2 of 3 participants developed DLTs within Cycle 1, dose-escalation was terminated, and the dose level 5 mg/kg below the current dose was considered the MTD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Samalizumab</intervention_name>
    <description>Samalizumab is a humanized, anti CD200 monoclonal antibody provided as a sterile 5 mg/milliliters (mL) solution for IV administration.</description>
    <arm_group_label>Samalizumab 10, 15, 20 milligrams (mg)/kilogram (kg) Dose</arm_group_label>
    <other_name>ALXN6000</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female participant was ≥ 18 years of age at Screening.&#xD;
&#xD;
          2. Eastern Cooperative Oncology Group performance status of 0 to 2.&#xD;
&#xD;
          3. Participant had advanced/metastatic cancer with disease progression after treatment&#xD;
             with all available therapies known to confer clinical benefit.&#xD;
&#xD;
          4. Participant had a life expectancy of greater than 12 weeks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participant had a symptomatic brain metastasis.&#xD;
&#xD;
          2. Participant had active gastrointestinal bleeding as evidenced by either hematemesis or&#xD;
             melena.&#xD;
&#xD;
          3. Participant had acute gastrointestinal ulcers.&#xD;
&#xD;
          4. Participant had a history of any cancer other than the present condition (except&#xD;
             nonmelanoma skin cancer or carcinoma in situ of the cervix), unless in complete&#xD;
             remission and off all therapy for that disease for a minimum of 3 years.&#xD;
&#xD;
          5. Participant with a condition requiring systemic treatment with either corticosteroids&#xD;
             or other immunosuppressive medications within 14 days of study drug administration.&#xD;
&#xD;
          6. Participant had an active infection requiring therapy.&#xD;
&#xD;
          7. Participant's serum was positive for the presence of hepatitis B surface antigen,&#xD;
             antibodies to hepatitis C virus, or antibodies to human immunodeficiency virus 1/2.&#xD;
&#xD;
          8. Participant had significant cardiovascular impairment (history of New York Heart&#xD;
             Association Functional Classification system Class III or IV) or a history of&#xD;
             myocardial infarction or unstable angina within the past 6 months prior to study drug&#xD;
             treatment.&#xD;
&#xD;
          9. The participant's most recent test values within 14 days before the date of entry met&#xD;
             the following standards:&#xD;
&#xD;
               -  Bone marrow function: neutrophil count ≤1500/millimeter (mm)^3, hemoglobin ≤9.0&#xD;
                  grams/deciliter, platelet count ≤100,000/mm^3.&#xD;
&#xD;
               -  Liver function: total bilirubin ≥1.5 x the upper limit of normal (ULN) based on&#xD;
                  the standard value of each institution, aspartate aminotransferase and alanine&#xD;
                  aminotransferase ≥2.5 x ULN based on the reference laboratory.&#xD;
&#xD;
               -  Renal function: serum creatinine ≥1.5 x ULN based on the reference laboratory.&#xD;
&#xD;
         10. Participant had ongoing immune-stimulated adverse events from other immunotherapies&#xD;
             (for example, pneumonitis, thyroiditis, or hepatitis) or a history of pneumonitis.&#xD;
&#xD;
         11. Participant had received chemotherapy, targeted therapy, and/or immunotherapy within&#xD;
             the 28 days prior to first dose of study drug, or within a Washout Period for the&#xD;
             chemotherapy, targeted therapy, and/or immunotherapy of 5 half-lives, whichever&#xD;
             occurred first.&#xD;
&#xD;
         12. Participant had toxicities from previous immunotherapy that had not resolved to Grade&#xD;
             1.&#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>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <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>July 2018</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>July 16, 2018</last_update_submitted>
  <last_update_submitted_qc>July 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cancer</keyword>
  <keyword>Solid tumor</keyword>
  <keyword>Phase 1</keyword>
  <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/NCT02987504
org study id: ALXN6000-ONC-102
nct id: NCT02987504
lead sponsor: 
collaborator: 
has dmc: No
This is a multicenter, open-label, dose-escalation, Phase 1 study of intravenous (IV)
      samalizumab to determine its maximum tolerated dose (MTD), overall safety/tolerability,
      pharmacokinetic and pharmacodynamic parameters, and efficacy in participants with advanced
      cancer. The study was terminated for administrative reasons and not due to any safety
      concerns.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number Of Participants Experiencing DLT Graded According To CTCAE Version 4.03, Observed In The Cycle 1 In Order To Meet The Objective Of Assessment Of The MTD
time frame: Safety monitoring began at the informed consent obtained and continued up to 28 days after the last dose of samalizumab or until new anti-tumor therapy, whichever was earlier.
description: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
measure: Maximum Plasma Concentration After Administration Of Samalizumab
time frame: 21 days in Cycle 1
measure: Area Under The Plasma Drug Concentration-time Curve After Administration Of Samalizumab
time frame: 21 days in Cycle 1
measure: Objective Response Rate Using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
time frame: Up to 2 Years
measure: Disease Control Rate Using RECIST 1.1
time frame: Up to 2 Years
measure: Duration Of Response
time frame: Up to 2 Years
measure: Progression Free Survival
time frame: Up to 2 Years
measure: Overall Survival
time frame: Up to last participant completing at least 6 months
arm group label: Samalizumab 10, 15, 20 milligrams (mg)/kilogram (kg) Dose
arm group type: Experimental
description: Participants received escalating doses of 10, 15, and 20 mg/kg of samalizumab IV every 21 days. Enrollment at each dose level and safety assessments were completed prior to enrolling at the next dose level; intra-participant dose escalation was not allowed.
3 participants were enrolled into a dose cohort: If 0/3 participants developed dose limiting toxicities (DLT) within Cycle 1, enrollment began at the next higher dose to a maximum of 20 mg/kg. If 1/3 participants developed a DLT, the dose cohort was expanded to include 3 new participants. If 0/3 new participants developed a DLT within Cycle 1, enrolment began at the next higher dose level. If ≥1 of 3 new participants developed a DLT within Cycle 1, dose-escalation was terminated, and the dose level 5 mg/kg below the current dose was considered the MTD. If ≥2 of 3 participants developed DLTs within Cycle 1, dose-escalation was terminated, and the dose level 5 mg/kg below the current dose was considered the MTD.
intervention type: Drug
intervention name: Samalizumab
description: Samalizumab is a humanized, anti CD200 monoclonal antibody provided as a sterile 5 mg/milliliters (mL) solution for IV administration.
arm group label: Samalizumab 10, 15, 20 milligrams (mg)/kilogram (kg) Dose
other name: ALXN6000
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No