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/NCT06005974</url>
    </required_header>
    <id_info>
      <org_study_id>REC-4881-221</org_study_id>
      <nct_id>NCT06005974</nct_id>
    </id_info>
    <brief_title>A Study of REC-4881 in Participants With Cancers Which Have an AXIN1 or APC Mutation</brief_title>
    <official_title>A Phase 2, Open Label Study of REC-4881 in Participants With Unresectable Locally Advanced or Metastatic Cancer With AXIN1 or APC Mutation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Recursion Pharmaceuticals Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Recursion Pharmaceuticals Inc.</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 is a multi-center, open-label study to investigate the safety, efficacy and&#xD;
        pharmacokinetics of REC-4881 (12 mg PO daily doses) for the treatment of participants with&#xD;
        unresectable locally advanced or metastatic solid tumors with AXIN1 or APC mutation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Approximately 60 individuals will be enrolled in this open-label Phase 2 study, allocated 1:1&#xD;
        between the 2 cohorts - AXIN1 mutation or APC mutation. The purpose of the study is to&#xD;
        investigate the safety, efficacy, and pharmacokinetics of REC-4881 for the treatment of&#xD;
        participants with unresectable locally advanced or metastatic solid tumors with either&#xD;
        mutation. Participants will receive treatment with REC-4881 (12mg PO daily) for up to 2&#xD;
        years.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">January 2027</completion_date>
    <primary_completion_date type="Anticipated">January 2027</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Participants are allocated to two groups, AXIN1 mutation or APC mutation, in parallel for the duration of the study.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of treatment emergent adverse events (AEs)</measure>
      <time_frame>Assessed from time of ICF signature through up to 24 months of study treatment</time_frame>
      <description>Safety and tolerability</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Evaluate the Objective Response Rate (ORR) of REC-4881 using RECIST 1.1 criteria</measure>
      <time_frame>Tumor imaging and RECIST assessments will occur at screening and at varying intervals through study completion, an average of 24 months</time_frame>
      <description>Efficacy</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Maximum (peak) plasma drug concentration (Cmax)</measure>
      <time_frame>Assessed pre-dose and at multiple timepoints up to 24 months</time_frame>
      <description>Efficacy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to reach maximum (peak) plasma concentration (Tmax)</measure>
      <time_frame>Assessed pre-dose and at multiple timepoints up to 24 months</time_frame>
      <description>Efficacy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the plasma concentration-time curve (AUC)</measure>
      <time_frame>Assessed pre-dose and at multiple timepoints up to 24 months</time_frame>
      <description>Efficacy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DOR) and Time to Response (TTR)</measure>
      <time_frame>Tumor imaging and RECIST assessments will occur at screening and at varying intervals through study completion, an average of 24 months</time_frame>
      <description>Efficacy</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>AXIN1 Gene Mutation</condition>
    <condition>APC Gene Mutation</condition>
    <condition>Solid Tumor</condition>
    <arm_group>
      <arm_group_label>AXIN1 Cohort</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive REC-4881 12mg PO dosed QD</description>
    </arm_group>
    <arm_group>
      <arm_group_label>APC Cohort</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive REC-4881 12mg PO dosed QD</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>REC-4881</intervention_name>
      <description>REC-4881 4mg capsules</description>
      <arm_group_label>APC Cohort</arm_group_label>
      <arm_group_label>AXIN1 Cohort</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. 18 years of age or older with histologically-confirmed unresectable, locally advanced,&#xD;
               or metastatic solid tumor with AXIN1 or APC mutation. If a participant has colorectal&#xD;
               cancer, then they must be RAS / RAF wild type to enroll into the APC mutant cohort&#xD;
  &#xD;
            2. Have experienced progressive disease, relapsed disease, or be intolerant to at least&#xD;
               one established standard systemic anti-cancer treatment, or in the opinion of the&#xD;
               Investigator have been considered ineligible for standard therapy&#xD;
  &#xD;
            3. Measurable disease at baseline per RECIST 1.1 criteria&#xD;
  &#xD;
            4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Received treatment with another mitogen-activated protein kinase (MEK) inhibitor&#xD;
               within two months of first dose of REC-4881&#xD;
  &#xD;
            2. Left ventricular ejection fraction (LVEF) &lt;50% as measured by echocardiogram (ECHO) or&#xD;
               multigated acquisition (MUGA) scan&#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>Recursion Pharmacueticals</last_name>
      <phone>385-374-1724</phone>
      <email>clinicaltrials@recursionpharma.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>AXIN1</keyword>
    <keyword>APC</keyword>
    <keyword>Locally advanced or metastatic</keyword>
    <keyword>Solid tumor</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Adenomatous Polyposis Coli</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06005974
  org study id: REC-4881-221
  nct id: NCT06005974
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  This is a multi-center, open-label study to investigate the safety, efficacy and
        pharmacokinetics of REC-4881 (12 mg PO daily doses) for the treatment of participants with
        unresectable locally advanced or metastatic solid tumors with AXIN1 or APC mutation.
  Approximately 60 individuals will be enrolled in this open-label Phase 2 study, allocated 1:1
        between the 2 cohorts - AXIN1 mutation or APC mutation. The purpose of the study is to
        investigate the safety, efficacy, and pharmacokinetics of REC-4881 for the treatment of
        participants with unresectable locally advanced or metastatic solid tumors with either
        mutation. Participants will receive treatment with REC-4881 (12mg PO daily) for up to 2
        years.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants are allocated to two groups, AXIN1 mutation or APC mutation, in parallel for the duration of the study.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence of treatment emergent adverse events (AEs)
  time frame: Assessed from time of ICF signature through up to 24 months of study treatment
  description: Safety and tolerability
  measure: Evaluate the Objective Response Rate (ORR) of REC-4881 using RECIST 1.1 criteria
  time frame: Tumor imaging and RECIST assessments will occur at screening and at varying intervals through study completion, an average of 24 months
  description: Efficacy
  measure: Maximum (peak) plasma drug concentration (Cmax)
  time frame: Assessed pre-dose and at multiple timepoints up to 24 months
  description: Efficacy
  measure: Time to reach maximum (peak) plasma concentration (Tmax)
  time frame: Assessed pre-dose and at multiple timepoints up to 24 months
  description: Efficacy
  measure: Area under the plasma concentration-time curve (AUC)
  time frame: Assessed pre-dose and at multiple timepoints up to 24 months
  description: Efficacy
  measure: Duration of Response (DOR) and Time to Response (TTR)
  time frame: Tumor imaging and RECIST assessments will occur at screening and at varying intervals through study completion, an average of 24 months
  description: Efficacy
  arm group label: AXIN1 Cohort
  arm group type: Experimental
  description: Participants will receive REC-4881 12mg PO dosed QD
  arm group label: APC Cohort
  arm group type: Experimental
  description: Participants will receive REC-4881 12mg PO dosed QD
  intervention type: Drug
  intervention name: REC-4881
  description: REC-4881 4mg capsules
  arm group label: APC Cohort
  arm group label: AXIN1 Cohort
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Recursion Pharmacueticals
  phone: 385-374-1724
  email: clinicaltrials@recursionpharma.com
  responsible party type: Sponsor
  mesh term: Adenomatous Polyposis Coli
  sharing ipd: No