xml: <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/NCT05985655</url>
    </required_header>
    <id_info>
      <org_study_id>GTAEXS617-001</org_study_id>
      <nct_id>NCT05985655</nct_id>
    </id_info>
    <brief_title>Study to Assess GTAEXS617 in Patients With Advanced Solid Tumors</brief_title>
    <acronym>ELUCIDATE</acronym>
    <official_title>A Phase 1/2 Open-label Multicenter Study to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of GTAEXS617 in Patients With Advanced Solid Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Exscientia AI Limited</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>GT Apeiron LLC</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Exscientia AI Limited</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        A phase 1/2 study to assess the safety, tolerability, pharmacokinetics and anti-tumor&#xD;
        activity of GTAEXS617-001 in patients with advanced solid tumors.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A phase 1/2 study to assess the safety, tolerability, pharmacokinetics and anti-tumor&#xD;
        activity of GTAEXS617-001 as monotherapy and in combination, in patients with one of the&#xD;
        following advanced solid tumors: head and neck squamous cell carcinoma, colorectal&#xD;
        adenocarcinoma, pancreatic adenocarcinoma, non-small cell lung cancer, breast cancer (HR+ and&#xD;
        HER2- that has progressed to a prior treatment with CD4/CDK6 inhibitor), ovarian epithelial&#xD;
        carcinoma.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 6, 2023</start_date>
    <completion_date type="Anticipated">May 2028</completion_date>
    <primary_completion_date type="Anticipated">January 2028</primary_completion_date>
    <phase>Phase 1/Phase 2</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>Module 1 Part A: To characterize the safety profile of GTAEXS617 as monotherapy</measure>
      <time_frame>Through patient study completion, an average of 6 months</time_frame>
      <description>Incidence of treatment-emergent adverse events (TEAEs), characterised by type, incidence, severity (graded by NCI CTCAE v5.0), seriousness, timing and relationship to GTAEXS617 dosing.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Module 1 Part A: To characterize the Dose Limiting Toxicities (DLTs) of GTAEXS617 as monotherapy</measure>
      <time_frame>Through patient study completion, an average of 6 months</time_frame>
      <description>Incidence of dose limiting toxicities (DLTs) during Cycle 1 of treatment.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Module 1 Part A: To establish the Recommended Phase 2 Dose (RP2D) of GTAEXS617 as monotherapy</measure>
      <time_frame>Through study completion for all patients in Module 1 Part A. Estimated 18 months.</time_frame>
      <description>The RP2D will not exceed the maximum tolerated dose (MTD) if established.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Module 1 Part B: To characterize the safety profile of GTAEXS617 in combination with selected Standard of Care (SoC) regimens</measure>
      <time_frame>Through patient study completion, an average of 6 months</time_frame>
      <description>Incidence of treatment-emergent adverse events (TEAEs), characterised by type, incidence, severity (graded by NCI CTCAE v5.0), seriousness, timing and relationship to GTAEXS617 dosing.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Module 1 Part B: To characterize the Dose Limiting Toxicities (DLTs) of GTAEXS617 in combination with selected Standard of Care (SoC) regimens</measure>
      <time_frame>Through patient study completion, an average of 6 months</time_frame>
      <description>Incidence of dose limiting toxicities (DLTs) during Cycle 1 of treatment</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Module 1 Part A: GTAEXS617 Maximum Plasma Concentration (Cmax)</measure>
      <time_frame>Through patient study completion, an average of 6 months</time_frame>
      <description>Maximum Plasma Concentration (Cmax) when GTAEXS617 administered as monotherapy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Module 1 Part A: GTAEXS617 Time Maximum Plasma Concentration (Tmax)</measure>
      <time_frame>Through patient study completion, an average of 6 months</time_frame>
      <description>Time Maximum Plasma Concentration (Tmax) when GTAEXS617 administered as monotherapy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Module 1 Part A: GTAEXS617 Area under Plasma Concentration Curve during 24 hour dosing interval (AUC 0-tau)</measure>
      <time_frame>Through patient study completion, an average of 6 months</time_frame>
      <description>Area under Plasma Concentration Curve during 24 hour dosing interval (AUC 0-tau) when GTAEXS617 administered as monotherapy</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">170</enrollment>
    <condition>Advanced Solid Tumor</condition>
    <arm_group>
      <arm_group_label>GTAEXS617</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>GTAEXS617 tablet for oral administration</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>GTAEXS617</intervention_name>
      <description>GTAEXS617 tablets daily</description>
      <arm_group_label>GTAEXS617</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ECOG performance status 0-1&#xD;
  &#xD;
            -  Life expectancy &gt;3 months&#xD;
  &#xD;
            -  One the following histologically or cytologically confirmed advanced solid tumors:&#xD;
               head and neck squamous cell carcinoma, colorectal adenocarcinoma, pancreatic&#xD;
               adenocarcinoma, NSCLC, breast carcinoma (HR+ and HER2- that has progressed to a prior&#xD;
               treatment with CD4/CDK6 inhibitor), or ovarian epithelial carcinoma&#xD;
  &#xD;
            -  Patients must have disease that is advanced (ie, surgery or radiotherapy are not&#xD;
               considered to be potentially curative), recurrent, or metastatic following SoC&#xD;
               treatments&#xD;
  &#xD;
            -  Adequate hematological, liver, and renal function&#xD;
  &#xD;
            -  Participant must have tumor lesion(s) or metastases amenable to biopsy, excluding bone&#xD;
               metastases&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Active and clinically significant (CS) infection&#xD;
  &#xD;
            -  Refractory nausea and/or vomiting, chronic gastrointestinal disease, or previous&#xD;
               significant bowel resection, with CS sequelae that would preclude adequate absorption&#xD;
               of GTAEXS617&#xD;
  &#xD;
            -  Symptomatic central nervous system (CNS) malignancy or metastases&#xD;
  &#xD;
            -  Concurrent active or previous malignancy&#xD;
  &#xD;
            -  Prior organ or allogeneic stem-cell transplantation&#xD;
  &#xD;
            -  Moderate or severe cardiovascular disease&#xD;
  &#xD;
            -  Received anticancer therapy within 28 days or 5 half-lives (whichever is shorter)&#xD;
               before the first dose of the study treatment&#xD;
  &#xD;
            -  Received treatment with known strong inhibitors and or inducers of cytochrome P450 3A&#xD;
               isoform subfamily (CYP3A) within 14 days or 5 half-lives before the first dose of&#xD;
               study treatment&#xD;
  &#xD;
            -  Received treatment with known inhibitors or inducers of P-glycoprotein (P-gp) or&#xD;
               breast cancer resistance protein (BCRP) within 14 days or 5 half-lives before the&#xD;
               first dose of study&#xD;
  &#xD;
            -  Received treatment with known substrates of organic anion transporting peptide 1B3&#xD;
               (OATP1B3) or BCRP within 14 days or 5 half-lives before the first dose of study&#xD;
               treatment&#xD;
  &#xD;
            -  Unresolved or unstable serious toxic side-effects of prior chemotherapy or&#xD;
               radiotherapy&#xD;
  &#xD;
            -  Has had or is scheduled to have major surgery &lt;28 days prior to the first dose of&#xD;
               study treatment&#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_contact>
      <last_name>Holly Garratt</last_name>
      <phone>+441865 818941</phone>
      <email>info@exscientia.co.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Eric Helmer</last_name>
      <phone>+441865 818941</phone>
      <email>info@exscientia.co.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Clinique Universitaires Saint-Luc</name>
        <address>
          <city>Brussels</city>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Rachel Galot</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05985655
  org study id: GTAEXS617-001
  nct id: NCT05985655
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  A phase 1/2 study to assess the safety, tolerability, pharmacokinetics and anti-tumor
        activity of GTAEXS617-001 in patients with advanced solid tumors.
  A phase 1/2 study to assess the safety, tolerability, pharmacokinetics and anti-tumor
        activity of GTAEXS617-001 as monotherapy and in combination, in patients with one of the
        following advanced solid tumors: head and neck squamous cell carcinoma, colorectal
        adenocarcinoma, pancreatic adenocarcinoma, non-small cell lung cancer, breast cancer (HR+ and
        HER2- that has progressed to a prior treatment with CD4/CDK6 inhibitor), ovarian epithelial
        carcinoma.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Module 1 Part A: To characterize the safety profile of GTAEXS617 as monotherapy
  time frame: Through patient study completion, an average of 6 months
  description: Incidence of treatment-emergent adverse events (TEAEs), characterised by type, incidence, severity (graded by NCI CTCAE v5.0), seriousness, timing and relationship to GTAEXS617 dosing.
  measure: Module 1 Part A: To characterize the Dose Limiting Toxicities (DLTs) of GTAEXS617 as monotherapy
  time frame: Through patient study completion, an average of 6 months
  description: Incidence of dose limiting toxicities (DLTs) during Cycle 1 of treatment.
  measure: Module 1 Part A: To establish the Recommended Phase 2 Dose (RP2D) of GTAEXS617 as monotherapy
  time frame: Through study completion for all patients in Module 1 Part A. Estimated 18 months.
  description: The RP2D will not exceed the maximum tolerated dose (MTD) if established.
  measure: Module 1 Part B: To characterize the safety profile of GTAEXS617 in combination with selected Standard of Care (SoC) regimens
  time frame: Through patient study completion, an average of 6 months
  description: Incidence of treatment-emergent adverse events (TEAEs), characterised by type, incidence, severity (graded by NCI CTCAE v5.0), seriousness, timing and relationship to GTAEXS617 dosing.
  measure: Module 1 Part B: To characterize the Dose Limiting Toxicities (DLTs) of GTAEXS617 in combination with selected Standard of Care (SoC) regimens
  time frame: Through patient study completion, an average of 6 months
  description: Incidence of dose limiting toxicities (DLTs) during Cycle 1 of treatment
  measure: Module 1 Part A: GTAEXS617 Maximum Plasma Concentration (Cmax)
  time frame: Through patient study completion, an average of 6 months
  description: Maximum Plasma Concentration (Cmax) when GTAEXS617 administered as monotherapy
  measure: Module 1 Part A: GTAEXS617 Time Maximum Plasma Concentration (Tmax)
  time frame: Through patient study completion, an average of 6 months
  description: Time Maximum Plasma Concentration (Tmax) when GTAEXS617 administered as monotherapy
  measure: Module 1 Part A: GTAEXS617 Area under Plasma Concentration Curve during 24 hour dosing interval (AUC 0-tau)
  time frame: Through patient study completion, an average of 6 months
  description: Area under Plasma Concentration Curve during 24 hour dosing interval (AUC 0-tau) when GTAEXS617 administered as monotherapy
  arm group label: GTAEXS617
  arm group type: Experimental
  description: GTAEXS617 tablet for oral administration
  intervention type: Drug
  intervention name: GTAEXS617
  description: GTAEXS617 tablets daily
  arm group label: GTAEXS617
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Holly Garratt
  phone: +441865 818941
  email: info@exscientia.co.uk
  last name: Eric Helmer
  phone: +441865 818941
  email: info@exscientia.co.uk
  facility: 
  status: Recruiting
  investigator: 
  country: Belgium
  responsible party type: Sponsor
  mesh term: Neoplasms