<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/NCT04446351</url>
  </required_header>
  <id_info>
    <org_study_id>212214</org_study_id>
    <nct_id>NCT04446351</nct_id>
  </id_info>
  <brief_title>Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors</brief_title>
  <official_title>A Phase 1 First-Time-in-Human, Open-Label Study of GSK6097608 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>23andMe, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>iTeos Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>GlaxoSmithKline</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>
      This first-time-in-human (FTIH) study will evaluate the safety, tolerability,&#xD;
      pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of escalating&#xD;
      doses of GSK6097608 given as monotherapy and in combination with dostarlimab in participants&#xD;
      with advanced solid tumors. In addition, dostarlimab will be given as monotherapy and in&#xD;
      combination with GSK6097608 and with GSK4428859A (EOS884448) in Japanese and Chinese&#xD;
      participants and dostarlimab will be given in combination with cobolimab in Japanese&#xD;
      participants. Drug name mentioned as GSK4428859A and EOS884448 are interchangeable for the&#xD;
      same compound. In the rest of the document, the drug will be referred to as GSK4428859A&#xD;
      (EOS884448).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 25, 2020</start_date>
  <completion_date type="Anticipated">July 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 30, 2024</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Participants will receive treatment in different dose escalation arms of the study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with dose-limiting toxicities (DLTs)</measure>
    <time_frame>Up to Day 21</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with adverse events (AEs) and serious adverse events (SAEs)</measure>
    <time_frame>Up to 2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with clinically significant changes in laboratory parameters, vital signs, and 12-lead electrocardiogram (ECG) findings</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with dose reductions or delay</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants withdrawn due to AEs</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms D, E, F, G: ORR based on modified Response Evaluation Criteria in Solid Tumors (iRECIST)</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms D, E, F, G: Disease Control Rate (DCR) based on RECIST 1.1</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms D, E, F, G: DCR based on iRECIST</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms D, E, F, G: Time to response (TTR) based on RECIST 1.1</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms D, E, F, G: TTR based on iRECIST</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms D, E, F, G: Duration of response (DOR) based on RECIST 1.1</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms D, E, F, G: DOR based on iRECIST</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms D, E, F, G: Progression-free survival (PFS) based on RECIST 1.1</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms D, E, F, G: PFS based on iRECIST</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms A, B, F: Number of participants with positive anti-drug antibodies (ADAs) against GSK6097608</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms A, B, F: Titers of ADAs against GSK6097608</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms B, D, E, F, G: Number of participants with positive ADAs against dostarlimab</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms B, D, E, F, G: Titers of ADAs against dostarlimab</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms E, F: Number of participants with positive ADAs against GSK4428859A (EOS884448)</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms E, F: Titers of ADAs against GSK4428859A (EOS884448)</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arm G: Number of participants with positive ADAs against cobolimab</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arm G: Titers of ADAs against cobolimab</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms A, B, F: Maximum observed concentration (Cmax) for GSK6097608</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms A, B, F: Minimum observed concentration (Cmin) for GSK6097608</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms A, B, F: Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC[0-infinity]) for GSK6097608</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms A, B, F: Area under the plasma concentration-time curve from time zero to time (AUC[0-t]) for GSK6097608</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms A, B, F: Apparent terminal phase half-life (t1/2) for GSK6097608</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms B, D, E, F, G: Cmax for dostarlimab</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms B, D, E, F, G: Cmin for dostarlimab</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms B, D, E, F, G: AUC(0-infinity) for dostarlimab</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms B, D, E, F, G: AUC(0-t) for dostarlimab</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms B, D, E, F, G: t1/2 for dostarlimab</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms E, F: Cmax for GSK4428859A (EOS884448)</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms E, F: Cmin for GSK4428859A (EOS884448)</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms E, F: AUC(0-infinity) for GSK4428859A (EOS884448)</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms E, F: AUC(0-t) for GSK4428859A (EOS884448)</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arms E, F: t1/2 for GSK4428859A (EOS884448)</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arm G: Cmax for cobolimab</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arm G: Cmin for cobolimab</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arm G: AUC(0-infinity) for cobolimab</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arm G: AUC(0-t) for cobolimab</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arm G: t1/2 for cobolimab</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">184</enrollment>
  <condition>Neoplasms</condition>
  <arm_group>
    <arm_group_label>Participants receiving GSK6097608 monotherapy (Arm A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be administered an intravenous (IV) infusion of GSK6097608 every 3 weeks as monotherapy in escalating doses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Participants receiving GSK6097608 plus dostarlimab (Arm B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be administered IV infusion of GSK6097608 every 3 weeks in escalating doses followed by dostarlimab.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Participants receiving dostarlimab monotherapy (Arm D)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be administered an IV infusion of dostarlimab monotherapy (1 cohort will receive dostarlimab every 3 weeks and 1 cohort will receive dostarlimab every 6 weeks).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Participants receiving dostarlimab plus GSK4428859A (EOS884448) (Arm E)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be administered IV infusions of dostarlimab followed by of GSK4428859A (EOS884448), every 3 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Participants receiving dostarlimab plus GSK4428859A (EOS884448) plus GSK6097608 (Arm F)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be administered an IV infusion of dostarlimab followed GSK4428859A (EOS884448) followed by GSK6097608 every 3 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Participants receiving dostarlimab plus cobolimab (Arm G)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be administered an IV infusion of cobolimab followed by dostarlimab</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GSK6097608</intervention_name>
    <description>GSK6097608 will be administered as an IV infusion.</description>
    <arm_group_label>Participants receiving GSK6097608 monotherapy (Arm A)</arm_group_label>
    <arm_group_label>Participants receiving GSK6097608 plus dostarlimab (Arm B)</arm_group_label>
    <arm_group_label>Participants receiving dostarlimab plus GSK4428859A (EOS884448) plus GSK6097608 (Arm F)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dostarlimab</intervention_name>
    <description>Dostarlimab will be administered as an IV infusion.</description>
    <arm_group_label>Participants receiving GSK6097608 plus dostarlimab (Arm B)</arm_group_label>
    <arm_group_label>Participants receiving dostarlimab monotherapy (Arm D)</arm_group_label>
    <arm_group_label>Participants receiving dostarlimab plus GSK4428859A (EOS884448) (Arm E)</arm_group_label>
    <arm_group_label>Participants receiving dostarlimab plus GSK4428859A (EOS884448) plus GSK6097608 (Arm F)</arm_group_label>
    <arm_group_label>Participants receiving dostarlimab plus cobolimab (Arm G)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GSK4428859A (EOS884448)</intervention_name>
    <description>GSK4428859A (EOS884448) will be administered as an IV infusion.</description>
    <arm_group_label>Participants receiving dostarlimab plus GSK4428859A (EOS884448) (Arm E)</arm_group_label>
    <arm_group_label>Participants receiving dostarlimab plus GSK4428859A (EOS884448) plus GSK6097608 (Arm F)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cobolimab</intervention_name>
    <description>Cobolimab will be administered as an IV infusion.</description>
    <arm_group_label>Participants receiving dostarlimab plus cobolimab (Arm G)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults 18 years of age or older (or &gt;=20 years of age in Arm-A Japan, Arm-D Japan, Arm&#xD;
             E-Japan, Arm F-Japan, and Arm G-Japan);&#xD;
&#xD;
          -  Female participants of childbearing potential must agree to use a highly effective&#xD;
             form of contraception;&#xD;
&#xD;
          -  Histological or cytological documentation of locally advanced, recurrent, or&#xD;
             metastatic solid malignancy;&#xD;
&#xD;
          -  Disease that has progressed after standard therapy for the specific tumor type, or for&#xD;
             which standard therapy has proven to be ineffective, intolerable, or is considered&#xD;
             inappropriate, or if no further standard therapy exists;&#xD;
&#xD;
          -  Participants in a PK/PD cohort must provide fresh tumor biopsies.&#xD;
&#xD;
          -  Eastern cooperative oncology group (ECOG) performance status (PS) 0 to 1&#xD;
&#xD;
          -  Life expectancy of at least 12 weeks.&#xD;
&#xD;
          -  Adequate organ function as determined by laboratory assessments.&#xD;
&#xD;
          -  Adequate cardiac ejection fraction as measured by echocardiogram.&#xD;
&#xD;
          -  Arm A-Japan, Arm D-Japan, Arm E-Japan, Arm F-Japan, and Arm G-Japan only: lives in&#xD;
             Japan and is racially Japanese, defined as all biological grandparents being Japanese.&#xD;
&#xD;
          -  Arm A-China, Arm B-China, Arm D-China, Arm E-China and Arm F-China only: is of Chinese&#xD;
             descent and lives in China.&#xD;
&#xD;
          -  Arm D, Arm E, Arm F, and Arm G only: has been deemed suitable for assigned treatment&#xD;
             based on assessment by the investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior anti-cancer treatment including investigational agents, immune checkpoint&#xD;
             inhibitors, chemotherapy, targeted therapy, and biological therapy: within 4 weeks or&#xD;
             5 half-lives of the drug, whichever is shorter.&#xD;
&#xD;
          -  Prior allogenic or autologous bone marrow transplantation or other solid organ&#xD;
             transplantation.&#xD;
&#xD;
          -  Toxicity from previous anticancer treatment, including; greater than or equal to (&gt;=)&#xD;
             Grade 3 immune-mediated toxicity considered related to prior immunotherapy and that&#xD;
             led to treatment discontinuation; or toxicity related to prior treatment that has not&#xD;
             resolved; or history of myocarditis of any grade during a previous treatment with&#xD;
             immunotherapy.&#xD;
&#xD;
          -  Known additional malignancy that progressed or required active treatment within the&#xD;
             last 2 years.&#xD;
&#xD;
          -  Uncontrolled or symptomatic central nervous system (CNS) metastases and/or&#xD;
             carcinomatous meningitis.&#xD;
&#xD;
          -  Active autoimmune disease that has required systemic disease-modifying or&#xD;
             immunosuppressive treatment within the last 2 years.&#xD;
&#xD;
          -  Concurrent medical condition requiring the use of systemic immunosuppressive&#xD;
             treatment.&#xD;
&#xD;
          -  Cirrhosis or current unstable liver or biliary disease per investigator assessment.&#xD;
&#xD;
          -  Active infection requiring systemic treatment, known human immunodeficiency virus&#xD;
             infection, or positive test for hepatitis B surface antigen (HBsAg) or hepatitis C&#xD;
             virus (HCV)&#xD;
&#xD;
          -  Prolonged QT as measured by electrocardiogram.&#xD;
&#xD;
          -  Allergen desensitization therapy within 4 weeks of starting study intervention.&#xD;
&#xD;
          -  History of hypersensitivity to any of the study interventions or their excipients.&#xD;
&#xD;
          -  History or evidence of significant cardiovascular (CV) risk.&#xD;
&#xD;
          -  Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural&#xD;
             effusions.&#xD;
&#xD;
          -  History of idiopathic pulmonary fibrosis; interstitial lung disease; organizing&#xD;
             pneumonia; noninfectious pneumonitis that required steroids, or evidence of active,&#xD;
             noninfectious pneumonitis.&#xD;
&#xD;
          -  Pregnant or lactating woman.&#xD;
&#xD;
          -  Receipt of live vaccine within 30 days of the start of study intervention.&#xD;
&#xD;
          -  Receipt of transfusion of blood products or administration of colony-stimulating&#xD;
             factors within 14 days before the first dose of study intervention.&#xD;
&#xD;
          -  Major surgery less than 4 weeks before the first dose of study intervention.&#xD;
&#xD;
          -  Known drug or alcohol abuse.&#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>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>US GSK Clinical Trials Call Center</last_name>
    <phone>877-379-3718</phone>
    <email>GSKClinicalSupportHD@gsk.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>EU GSK Clinical Trials Call Center</last_name>
    <phone>+44 (0) 20 89904466</phone>
    <email>GSKClinicalSupportHD@gsk.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90025</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Omid Hamid</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Frank Stephen Hodi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Reva Elaine Schneider</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030-4009</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Jordi Rodón Ahnert</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Drew W Rasco</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Scott A Laurie</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Lillian Siu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK investigational Site</name>
      <address>
        <city>Chiba</city>
        <zip>277-8577</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Center</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Yoshitake Zenke</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>104-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Noboru Yamamoto</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Dong Wan Kim</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>US GSK Clinical Trials Call Center</last_name>
      <phone>877-379-3718</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact>
    <contact_backup>
      <last_name>EU GSK Clinical Trials Call Centre</last_name>
      <phone>+44 (0) 20 8990 4466</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </contact_backup>
    <investigator>
      <last_name>Myung-Ju Ahn</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>June 22, 2023</last_update_submitted>
  <last_update_submitted_qc>June 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>GSK6097608</keyword>
  <keyword>Dostarlimab</keyword>
  <keyword>Dose escalation</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Pharmacodynamics</keyword>
  <keyword>Advanced solid tumors</keyword>
  <keyword>First-time-in-human</keyword>
  <keyword>GSK4428859A</keyword>
  <keyword>EOS884448</keyword>
  <keyword>Cobolimab</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dostarlimab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications</ipd_time_frame>
    <ipd_access_criteria>Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months</ipd_access_criteria>
    <ipd_url>https://www.gsk.com/en-gb/innovation/trials/data-transparency/</ipd_url>
  </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/NCT04446351
org study id: 212214
nct id: NCT04446351
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This first-time-in-human (FTIH) study will evaluate the safety, tolerability,
      pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of escalating
      doses of GSK6097608 given as monotherapy and in combination with dostarlimab in participants
      with advanced solid tumors. In addition, dostarlimab will be given as monotherapy and in
      combination with GSK6097608 and with GSK4428859A (EOS884448) in Japanese and Chinese
      participants and dostarlimab will be given in combination with cobolimab in Japanese
      participants. Drug name mentioned as GSK4428859A and EOS884448 are interchangeable for the
      same compound. In the rest of the document, the drug will be referred to as GSK4428859A
      (EOS884448).
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Participants will receive treatment in different dose escalation arms of the study.
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with dose-limiting toxicities (DLTs)
time frame: Up to Day 21
measure: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
time frame: Up to 2 years
measure: Number of participants with clinically significant changes in laboratory parameters, vital signs, and 12-lead electrocardiogram (ECG) findings
time frame: Up to 2 years
measure: Number of participants with dose reductions or delay
time frame: Up to 2 years
measure: Number of participants withdrawn due to AEs
time frame: Up to 2 years
measure: Overall response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
time frame: Up to 2 years
measure: Arms D, E, F, G: ORR based on modified Response Evaluation Criteria in Solid Tumors (iRECIST)
time frame: Up to 2 years
measure: Arms D, E, F, G: Disease Control Rate (DCR) based on RECIST 1.1
time frame: Up to 2 years
measure: Arms D, E, F, G: DCR based on iRECIST
time frame: Up to 2 years
measure: Arms D, E, F, G: Time to response (TTR) based on RECIST 1.1
time frame: Up to 2 years
measure: Arms D, E, F, G: TTR based on iRECIST
time frame: Up to 2 years
measure: Arms D, E, F, G: Duration of response (DOR) based on RECIST 1.1
time frame: Up to 2 years
measure: Arms D, E, F, G: DOR based on iRECIST
time frame: Up to 2 years
measure: Arms D, E, F, G: Progression-free survival (PFS) based on RECIST 1.1
time frame: Up to 2 years
measure: Arms D, E, F, G: PFS based on iRECIST
time frame: Up to 2 years
measure: Arms A, B, F: Number of participants with positive anti-drug antibodies (ADAs) against GSK6097608
time frame: Up to 2 years
measure: Arms A, B, F: Titers of ADAs against GSK6097608
time frame: Up to 2 years
measure: Arms B, D, E, F, G: Number of participants with positive ADAs against dostarlimab
time frame: Up to 2 years
measure: Arms B, D, E, F, G: Titers of ADAs against dostarlimab
time frame: Up to 2 years
measure: Arms E, F: Number of participants with positive ADAs against GSK4428859A (EOS884448)
time frame: Up to 2 years
measure: Arms E, F: Titers of ADAs against GSK4428859A (EOS884448)
time frame: Up to 2 years
measure: Arm G: Number of participants with positive ADAs against cobolimab
time frame: Up to 2 years
measure: Arm G: Titers of ADAs against cobolimab
time frame: Up to 2 years
measure: Arms A, B, F: Maximum observed concentration (Cmax) for GSK6097608
time frame: Up to 2 years
measure: Arms A, B, F: Minimum observed concentration (Cmin) for GSK6097608
time frame: Up to 2 years
measure: Arms A, B, F: Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC[0-infinity]) for GSK6097608
time frame: Up to 2 years
measure: Arms A, B, F: Area under the plasma concentration-time curve from time zero to time (AUC[0-t]) for GSK6097608
time frame: Up to 2 years
measure: Arms A, B, F: Apparent terminal phase half-life (t1/2) for GSK6097608
time frame: Up to 2 years
measure: Arms B, D, E, F, G: Cmax for dostarlimab
time frame: Up to 2 years
measure: Arms B, D, E, F, G: Cmin for dostarlimab
time frame: Up to 2 years
measure: Arms B, D, E, F, G: AUC(0-infinity) for dostarlimab
time frame: Up to 2 years
measure: Arms B, D, E, F, G: AUC(0-t) for dostarlimab
time frame: Up to 2 years
measure: Arms B, D, E, F, G: t1/2 for dostarlimab
time frame: Up to 2 years
measure: Arms E, F: Cmax for GSK4428859A (EOS884448)
time frame: Up to 2 years
measure: Arms E, F: Cmin for GSK4428859A (EOS884448)
time frame: Up to 2 years
measure: Arms E, F: AUC(0-infinity) for GSK4428859A (EOS884448)
time frame: Up to 2 years
measure: Arms E, F: AUC(0-t) for GSK4428859A (EOS884448)
time frame: Up to 2 years
measure: Arms E, F: t1/2 for GSK4428859A (EOS884448)
time frame: Up to 2 years
measure: Arm G: Cmax for cobolimab
time frame: Up to 2 years
measure: Arm G: Cmin for cobolimab
time frame: Up to 2 years
measure: Arm G: AUC(0-infinity) for cobolimab
time frame: Up to 2 years
measure: Arm G: AUC(0-t) for cobolimab
time frame: Up to 2 years
measure: Arm G: t1/2 for cobolimab
time frame: Up to 2 years
arm group label: Participants receiving GSK6097608 monotherapy (Arm A)
arm group type: Experimental
description: Participants will be administered an intravenous (IV) infusion of GSK6097608 every 3 weeks as monotherapy in escalating doses.
arm group label: Participants receiving GSK6097608 plus dostarlimab (Arm B)
arm group type: Experimental
description: Participants will be administered IV infusion of GSK6097608 every 3 weeks in escalating doses followed by dostarlimab.
arm group label: Participants receiving dostarlimab monotherapy (Arm D)
arm group type: Experimental
description: Participants will be administered an IV infusion of dostarlimab monotherapy (1 cohort will receive dostarlimab every 3 weeks and 1 cohort will receive dostarlimab every 6 weeks).
arm group label: Participants receiving dostarlimab plus GSK4428859A (EOS884448) (Arm E)
arm group type: Experimental
description: Participants will be administered IV infusions of dostarlimab followed by of GSK4428859A (EOS884448), every 3 weeks.
arm group label: Participants receiving dostarlimab plus GSK4428859A (EOS884448) plus GSK6097608 (Arm F)
arm group type: Experimental
description: Participants will be administered an IV infusion of dostarlimab followed GSK4428859A (EOS884448) followed by GSK6097608 every 3 weeks.
arm group label: Participants receiving dostarlimab plus cobolimab (Arm G)
arm group type: Experimental
description: Participants will be administered an IV infusion of cobolimab followed by dostarlimab
intervention type: Drug
intervention name: GSK6097608
description: GSK6097608 will be administered as an IV infusion.
arm group label: Participants receiving GSK6097608 monotherapy (Arm A)
arm group label: Participants receiving GSK6097608 plus dostarlimab (Arm B)
arm group label: Participants receiving dostarlimab plus GSK4428859A (EOS884448) plus GSK6097608 (Arm F)
intervention type: Drug
intervention name: Dostarlimab
description: Dostarlimab will be administered as an IV infusion.
arm group label: Participants receiving GSK6097608 plus dostarlimab (Arm B)
arm group label: Participants receiving dostarlimab monotherapy (Arm D)
arm group label: Participants receiving dostarlimab plus GSK4428859A (EOS884448) (Arm E)
arm group label: Participants receiving dostarlimab plus GSK4428859A (EOS884448) plus GSK6097608 (Arm F)
arm group label: Participants receiving dostarlimab plus cobolimab (Arm G)
intervention type: Drug
intervention name: GSK4428859A (EOS884448)
description: GSK4428859A (EOS884448) will be administered as an IV infusion.
arm group label: Participants receiving dostarlimab plus GSK4428859A (EOS884448) (Arm E)
arm group label: Participants receiving dostarlimab plus GSK4428859A (EOS884448) plus GSK6097608 (Arm F)
intervention type: Drug
intervention name: Cobolimab
description: Cobolimab will be administered as an IV infusion.
arm group label: Participants receiving dostarlimab plus cobolimab (Arm G)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
last name: US GSK Clinical Trials Call Center
phone: 877-379-3718
email: GSKClinicalSupportHD@gsk.com
last name: EU GSK Clinical Trials Call Center
phone: +44 (0) 20 89904466
email: GSKClinicalSupportHD@gsk.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Canada
country: Japan
country: Korea, Republic of
country: United States
responsible party type: Sponsor
mesh term: Dostarlimab
sharing ipd: Yes
ipd description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications
ipd access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months
ipd url: https://www.gsk.com/en-gb/innovation/trials/data-transparency/