<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/NCT03762447</url>
  </required_header>
  <id_info>
    <org_study_id>INCB 86550-102</org_study_id>
    <nct_id>NCT03762447</nct_id>
  </id_info>
  <brief_title>A Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors</brief_title>
  <official_title>A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Incyte Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Incyte Corporation</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 and tolerability, pharmacokinetics,&#xD;
      pharmacodynamics, and early clinical activity of INCB086550 in participants with advanced&#xD;
      solid tumors who have failed prior treatments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 10, 2018</start_date>
  <completion_date type="Anticipated">February 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 29, 2023</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 treatment-emergent adverse events</measure>
    <time_frame>Baseline through 90 days after end of treatment, estimated up to 12 months.</time_frame>
    <description>Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax of INCB086550 in fasted and food effect conditions</measure>
    <time_frame>Approximately 1 month</time_frame>
    <description>Maximum observed plasma or serum concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax of INCB086550 in fasted and food effect conditions</measure>
    <time_frame>Approximately 1 month</time_frame>
    <description>Time to maximum concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-tau of INCB086550 in fasted and food effect conditions</measure>
    <time_frame>Approximately 1 month</time_frame>
    <description>Area under the plasma or serum concentration-time curve from time = 0 to the end of dosing period at steady state</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC 0-t and/or AUC0-∞ of INCB086550 in fasted and food effect conditions</measure>
    <time_frame>Approximately 1 month</time_frame>
    <description>Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration, or Area under the single-dose plasma concentration-time curve from Hour 0 to infinity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t½ of INCB086550</measure>
    <time_frame>Approximately 1 month</time_frame>
    <description>Apparent terminal-phase disposition half-life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz of INCB086550</measure>
    <time_frame>Approximately 1 month</time_frame>
    <description>Apparent terminal-phase disposition rate constant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F of INCB086550</measure>
    <time_frame>Approximately 1 month</time_frame>
    <description>Apparent oral dose clearance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F of INCB086550</measure>
    <time_frame>Approximately 1 month</time_frame>
    <description>Apparent oral dose volume of distribution.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic/pharmacodynamics correlation</measure>
    <time_frame>Approximately 1 month</time_frame>
    <description>Evaluation of the ability of INCB086550 to modulate PD-L1 expression levels as assessed by flow cytometry protein analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate</measure>
    <time_frame>Every 8 weeks for the duration of study participation; estimated to be 12 months.</time_frame>
    <description>Defined as the percentage of participants having complete response (CR) or partial response (PR) by investigator assessment of radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or response assessment in Neuro-Oncology (RANO).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate</measure>
    <time_frame>Every 8 weeks for the duration of study participation; estimated to be 12 months.</time_frame>
    <description>Defined as the percentage of participants having CR, PR, or stable disease ≥ 12 weeks by investigator assessment of radiographic disease assessments per RECIST v1.1 or response assessment in Neuro-Oncology (RANO).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response</measure>
    <time_frame>Every 8 weeks for the duration of study participation; estimated to be 12 months.</time_frame>
    <description>Defined as the time from the first documented evidence of CR or PR until the earliest date of disease progression by investigator assessment per RECIST v1.1 for response assessment in Neuro-Oncology (RANO), or death due to any cause, if occurring sooner than progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmin of INCB086550 in fasted and food effect conditions</measure>
    <time_frame>Approximately 1 month</time_frame>
    <description>Minimum observed plasma or serum concentration of INCB086550</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">138</enrollment>
  <condition>Solid Tumors</condition>
  <arm_group>
    <arm_group_label>INCB086550</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>INCB086550</intervention_name>
    <description>INCB086550 will be orally administered once or twice daily in continuous or intermittent dose schedules.</description>
    <arm_group_label>INCB086550</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed advanced solid tumors with measurable lesions per RECIST v1.1&#xD;
             or RANO for primary brain tumors that are considered nonamenable to surgery or other&#xD;
             curative treatments or procedures. Tumor lesions located in a previously irradiated&#xD;
             area, or in an area subjected to other loco-regional therapy, are considered&#xD;
             measurable per RECIST v1.1 if progression has been demonstrated in the lesion.&#xD;
&#xD;
          -  Willingness to undergo a tumor biopsy to obtain tumor tissue,Pretreatment and&#xD;
             on-treatment tumor biopsies are required.&#xD;
&#xD;
          -  Must have disease progression after treatment with available therapies that are known&#xD;
             to confer clinical benefit or who are intolerant to or ineligible for standard&#xD;
             treatment. There is no limit to the number of prior treatment regimens.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status score of 0 or 1.&#xD;
&#xD;
          -  Life expectancy &gt; 12 weeks.&#xD;
&#xD;
          -  Willingness to avoid pregnancy or fathering children.&#xD;
&#xD;
          -  Part 2 Expansion Cohort 2-A only: Participants with any type of solid tumor that has a&#xD;
             local regulatory approval for an anti-PD-1 therapy. Other tumor types may be enrolled&#xD;
             with medical monitor approval. Participants must have had confirmed disease&#xD;
             progression on a prior anti-PD-1 monoclonal antibody.&#xD;
&#xD;
          -  Part 2 Expansion Cohort 2-B only: Participants with select solid tumors who are&#xD;
             immunotherapy-naïve.&#xD;
&#xD;
          -  Part 3 MSI-H or dMMR Expansion Cohort only (Enrolled ex-United States only):&#xD;
             Participants with any MSI-H or dMMR solid tumor who are immunotherapy-naïve.&#xD;
&#xD;
          -  Part 4 HPV-driven expansion cohort only: Participants with any HPV-positive solid&#xD;
             tumor who have received prior standard therapy.&#xD;
&#xD;
        Note: HPV-positive status determined by a local laboratory using p16 IHC, polymerase chain&#xD;
        reaction methods, or other locally-available method to detect HPV&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Laboratory values not within the Protocol-defined range.&#xD;
&#xD;
          -  Clinically significant cardiac disease.&#xD;
&#xD;
          -  History or presence of an ECG that, in the investigator's opinion, is clinically&#xD;
             meaningful.&#xD;
&#xD;
          -  Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases&#xD;
             that have progressed. Participants who have previously treated and clinically stable&#xD;
             brain or CNS metastases and have not required steroids for at least 7 days before&#xD;
             study treatment are eligible.&#xD;
&#xD;
          -  Known additional malignancy that is progressing or requires active treatment.&#xD;
&#xD;
          -  Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy and/or&#xD;
             complications from prior surgical intervention before starting study treatment.&#xD;
&#xD;
          -  Treatment with anticancer medications or investigational drugs within protocol-defined&#xD;
             intervals before the first administration of study drug.&#xD;
&#xD;
          -  Active infection requiring systemic therapy.&#xD;
&#xD;
          -  Active HBV or HCV infection that requires treatment.&#xD;
&#xD;
          -  Known history of HIV (HIV 1/2 antibodies).&#xD;
&#xD;
          -  Known hypersensitivity or severe reaction to any component of study drug or&#xD;
             formulation components.&#xD;
&#xD;
          -  Prior receipt of an anti-PD-L1 therapy for all participants.&#xD;
&#xD;
          -  Presence of a gastrointestinal condition that may affect drug absorption.&#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>Kevin O'Hayer, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Incyte Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Georgetown University Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. Lee Moffitt Cancer Center and Research Institute Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aamc Oncology and Hematology</name>
      <address>
        <city>Annapolis</city>
        <state>Maryland</state>
        <zip>21401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania Health System</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jefferson University Hospitals</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarah Cannon Research Institute</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Md Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Jules Bordet</name>
      <address>
        <city>Brussels</city>
        <zip>01000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Antwerpen (Uza)</name>
      <address>
        <city>Edegem</city>
        <zip>02650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gent</name>
      <address>
        <city>Gent</city>
        <zip>09000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaire Ziekenhuis Leuven - Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <zip>03000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Hopital de La Timone</name>
      <address>
        <city>Marseille Cedex 5</city>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icm Montpellier</name>
      <address>
        <city>Montpellier Cedex 5</city>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Curie</name>
      <address>
        <city>Paris</city>
        <zip>75005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Universitaire Du Cancer de Toulouse Oncopole</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Irccs Istituto Nazionale Dei Tumori</name>
      <address>
        <city>Milan</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>European Institute of Oncology</name>
      <address>
        <city>Milan</city>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Nazionale Tumori Irccs Fondazione Pascale</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Irrcs Instituto Clinico Humanitas</name>
      <address>
        <city>Rozzano</city>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte</name>
      <address>
        <city>Siena</city>
        <zip>53100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Addenbrooke'S Hospital</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guys and St Thomas Nhs Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imperial College Healthcare Nhs Trust - Hammersmith Hospital</name>
      <address>
        <city>London</city>
        <zip>W12 0HS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Christie Nhs Foundation Trust Uk</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weston Park Hospital</name>
      <address>
        <city>Sheffield</city>
        <zip>S10 2SJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
    <country>Italy</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>June 28, 2023</last_update_submitted>
  <last_update_submitted_qc>June 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>solid tumors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <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/NCT03762447
org study id: INCB 86550-102
nct id: NCT03762447
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 and tolerability, pharmacokinetics,
      pharmacodynamics, and early clinical activity of INCB086550 in participants with advanced
      solid tumors who have failed prior treatments.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of treatment-emergent adverse events
time frame: Baseline through 90 days after end of treatment, estimated up to 12 months.
description: Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
measure: Cmax of INCB086550 in fasted and food effect conditions
time frame: Approximately 1 month
description: Maximum observed plasma or serum concentration.
measure: tmax of INCB086550 in fasted and food effect conditions
time frame: Approximately 1 month
description: Time to maximum concentration.
measure: AUC0-tau of INCB086550 in fasted and food effect conditions
time frame: Approximately 1 month
description: Area under the plasma or serum concentration-time curve from time = 0 to the end of dosing period at steady state
measure: AUC 0-t and/or AUC0-∞ of INCB086550 in fasted and food effect conditions
time frame: Approximately 1 month
description: Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration, or Area under the single-dose plasma concentration-time curve from Hour 0 to infinity
measure: t½ of INCB086550
time frame: Approximately 1 month
description: Apparent terminal-phase disposition half-life.
measure: λz of INCB086550
time frame: Approximately 1 month
description: Apparent terminal-phase disposition rate constant
measure: CL/F of INCB086550
time frame: Approximately 1 month
description: Apparent oral dose clearance.
measure: Vz/F of INCB086550
time frame: Approximately 1 month
description: Apparent oral dose volume of distribution.
measure: Pharmacokinetic/pharmacodynamics correlation
time frame: Approximately 1 month
description: Evaluation of the ability of INCB086550 to modulate PD-L1 expression levels as assessed by flow cytometry protein analyses.
measure: Objective response rate
time frame: Every 8 weeks for the duration of study participation; estimated to be 12 months.
description: Defined as the percentage of participants having complete response (CR) or partial response (PR) by investigator assessment of radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or response assessment in Neuro-Oncology (RANO).
measure: Disease control rate
time frame: Every 8 weeks for the duration of study participation; estimated to be 12 months.
description: Defined as the percentage of participants having CR, PR, or stable disease ≥ 12 weeks by investigator assessment of radiographic disease assessments per RECIST v1.1 or response assessment in Neuro-Oncology (RANO).
measure: Duration of response
time frame: Every 8 weeks for the duration of study participation; estimated to be 12 months.
description: Defined as the time from the first documented evidence of CR or PR until the earliest date of disease progression by investigator assessment per RECIST v1.1 for response assessment in Neuro-Oncology (RANO), or death due to any cause, if occurring sooner than progression.
measure: Cmin of INCB086550 in fasted and food effect conditions
time frame: Approximately 1 month
description: Minimum observed plasma or serum concentration of INCB086550
arm group label: INCB086550
arm group type: Experimental
intervention type: Drug
intervention name: INCB086550
description: INCB086550 will be orally administered once or twice daily in continuous or intermittent dose schedules.
arm group label: INCB086550
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kevin O'Hayer, MD, PhD
role: Study Director
affiliation: Incyte Corporation
facility: 
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country: Belgium
country: France
country: Italy
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: No