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/NCT05963997</url>
    </required_header>
    <id_info>
      <org_study_id>CT7001_003</org_study_id>
      <secondary_id>2023-503846-30-00</secondary_id>
      <secondary_id>2023-000072-35</secondary_id>
      <nct_id>NCT05963997</nct_id>
    </id_info>
    <brief_title>A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer</brief_title>
    <acronym>SUMIT-ELA</acronym>
    <official_title>A Phase 1b/2 Open-label Study of Samuraciclib in Combination With Elacestrant in Participants With Metastatic or Locally Advanced Hormone Receptor-positive and Human Epidermal Growth Factor Receptor 2-negative Breast Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Carrick Therapeutics Limited</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Berlin-Chemie AG Menarini Group</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Carrick Therapeutics Limited</source>
    <oversight_info>
      <has_dmc>Yes</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 an international, multisite, open-label, Phase 1b/2 study, to confirm safety and&#xD;
        efficacy of samuraciclib in combination with elacestrant in adult participants with&#xD;
        metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth&#xD;
        Factor Receptor (HER)2-negative breast cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a multiple cohort study, an initial dose escalation phase is designed to confirm the&#xD;
        safe dose of samuraciclib in combination with elacestrant. A Safety Review Committee (SRC)&#xD;
        will monitor the safety, tolerability, and PK data during this phase. Once ascertained, an&#xD;
        expansion cohort will be opened to explore the efficacy of samuraciclib in combination with&#xD;
        elacestrant.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">June 16, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 23, 2024</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>Non-Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Phase 1b (Dose-finding)</measure>
      <time_frame>From the date of first dose of any study intervention (Day 1 Cycle 1) and through 28 days after the last dose of any study intervention</time_frame>
      <description>Identification of Samuraciclib + Elacestrant combination, Phase 2, expansion dose level.&#xD;
  Incidence and severity of adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse events (NCI-CTCAE) v5.0. Safety will be assessed by monitoring treatment - emerged severe and dose limiting adverse events and clinically relevant changes in vital signs and clinical laboratory results</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Phase 2 (Expansion)</measure>
      <time_frame>From the date of first dose of any study intervention (Cycle 1 Day 1) until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)</time_frame>
      <description>Progression Free Survival (PFS) is defined as the time from the date of first dose of IMP (Cycle 1 Day 1) to the date of the first documentation of objective progressive disease (PD) or death due to any cause, whichever occurs first.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Treatment-Emergent Adverse Events and Laboratory Abnormalities (Safety and Tolerability)</measure>
      <time_frame>From the date of first dose of any study intervention through 28 days after the last dose of any study intervention</time_frame>
      <description>Type, incidence, severity (as graded by CTCAE v5.0), seriousness and relationship to study medications of AEs and any laboratory abnormalities. Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical Benefit Response (CBR)</measure>
      <time_frame>From the date of first dose of any study intervention (Cycle 1 Day 1) to ≥ 24 weeks or until disease progression or death to any cause (assessed up to week 24)</time_frame>
      <description>CBR is defined as the overall complete response (CR), partial response (PR), or stable disease (SD) ≥ 24 weeks according to RECIST version 1.1 recorded from enrolment until disease progression, or death due to any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall response rate (ORR)</measure>
      <time_frame>the date of first dose of study intervention (Cycle 1 Day 1) until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)</time_frame>
      <description>ORR is defined as the proportion of participants with a reduction in tumor burden with CR or PR according to RECIST version 1.1.&#xD;
  ORR will be estimated for participants who received at least 1 dose of IMP, had measurable disease at baseline and had a postbaseline tumor assessment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DOR)</measure>
      <time_frame>From the date of first dose of study intervention (Cycle 1 Day 1) until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)</time_frame>
      <description>DOR is defined as the time from the date of first documentation of objective tumor response (CR or PR) to the earliest documented disease progression per RECIST version 1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Best percent change in tumor size.</measure>
      <time_frame>From the date of first dose of study intervention (Cycle 1 Day 1) until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)</time_frame>
      <description>Best percent change in tumor size is defined as the percentage change in the sum of the longest diameters of target lesions</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Samuraciclib plasma exposure: Cmax</measure>
      <time_frame>Day 1 of Cycles 1 and Cycle 2 (each cycle is 28 days)</time_frame>
      <description>Plasma concentration for Samuraciclib</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Elacestrant exposure: Cmax</measure>
      <time_frame>Day 1 of Cycles 1 and Cycle 2 (each cycle is 28 days)</time_frame>
      <description>Plasma concentrations for Elacestrant</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Samuraciclib plasma exposure: Ctrough</measure>
      <time_frame>Cycle 1 Day 2 and 15; Day 2 of Cycle 2; Day 1 of Cycles 3-6 and end of treatment within 28 days of last dose of IMP and prior to the initiation of a new anticancer therapy (each cycle is 28 days)]</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Elacestrant exposure: Ctrough</measure>
      <time_frame>Cycle 1 Day 2 and Day 15; Cycle 2 Day 2 of Cycle 2 and Day 1 of Cycles 3-6 and at end of treatment within 28 days of the last dose of IMP and prior to the initiation of a new anticancer therapy (each cycle is 28 days)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Genotyping for ESR1 and TP53 mutations</measure>
      <time_frame>Screening</time_frame>
      <description>Genotyping for ESR1 and TP53 mutations to evaluate correlations between ESR1 and TP53 mutations and efficacy/safety findings</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Metastatic Breast Cancer</condition>
    <condition>Locally Advanced Breast Cancer</condition>
    <condition>Breast Cancer</condition>
    <arm_group>
      <arm_group_label>Cohort 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Up to 6 evaluable participants will receive samuraciclib 240 mg in combination with elacestrant 300 mg in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Up to 6 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 300 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Up to 6 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 400 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 4 Expansion</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Up to 30 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 400 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward).</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Samuraciclib</intervention_name>
      <description>Samuraciclib capsules by mouth once a day</description>
      <arm_group_label>Cohort 1</arm_group_label>
      <arm_group_label>Cohort 2</arm_group_label>
      <arm_group_label>Cohort 3</arm_group_label>
      <arm_group_label>Cohort 4 Expansion</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Elacestrant Dihydrochloride</intervention_name>
      <description>Elacestrant tablets by mouth once a day</description>
      <arm_group_label>Cohort 1</arm_group_label>
      <arm_group_label>Cohort 2</arm_group_label>
      <arm_group_label>Cohort 3</arm_group_label>
      <arm_group_label>Cohort 4 Expansion</arm_group_label>
      <other_name>ORSERDU</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Histologically confirmed diagnosis of ER-positive, HER2-negative locally advanced or&#xD;
               metastatic breast cancer.&#xD;
  &#xD;
            -  Documented objective disease progression while on or within 6 months after the end of&#xD;
               the most recent therapy.&#xD;
  &#xD;
            -  Received prior AI in combination with a CDK4/6i as the last therapy&#xD;
  &#xD;
            -  Known TP53 and ESR1 mutation status.&#xD;
  &#xD;
            -  Participants must have measurable disease or bone only disease as defined by Response&#xD;
               Evaluation Criteria in Solid Tumors (RECIST) version 1.1.&#xD;
  &#xD;
            -  Pre/peri-menopausal participants must have commenced treatment with a luteinizing&#xD;
               hormone-releasing hormone (LHRH) agonist at least 4 weeks prior to first dose of study&#xD;
               intervention.&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status ≤1 with no deterioration&#xD;
               over the past 2 weeks.&#xD;
  &#xD;
            -  Expected life expectancy of &gt;12 weeks in the judgement of the treating investigator.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inflammatory breast cancer.&#xD;
  &#xD;
            -  Participants with any other active malignancy within 3 years prior to enrollment,&#xD;
               except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in&#xD;
               situ of the cervix.&#xD;
  &#xD;
            -  More than 1 line of endocrine treatment for locally advanced or metastatic disease&#xD;
               treatment.&#xD;
  &#xD;
            -  Inadequate hepatic, renal, and bone marrow function.&#xD;
  &#xD;
            -  Clinically significant cardiovascular disease.&#xD;
  &#xD;
            -  Any current or prior central nervous system metastases, carcinomatous meningitis, or&#xD;
               leptomeningeal disease.&#xD;
  &#xD;
            -  Pregnant or breastfeeding women.&#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>Clinical Operations</last_name>
      <phone>+353 1 5996873</phone>
      <email>hello@carricktherapeutics.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Site 43 - Mid Florida Hematology and Oncology Center</name>
        <address>
          <city>Orange City</city>
          <state>Florida</state>
          <zip>32763</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Site 38 - Northwestern University, Feinberg School of Medicine, Northwestern University</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60611</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Site 40 - Massachusetts General Hospital</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02114-2696</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Site 42 - Dana-Farber Cancer Institute, EDDC</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02215</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Site 35 - Cleveland Clinic, Taussig Cancer Institute</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44106</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Site 34 -The University of Texas, MD Anderson Cancer Center, Nellie B. Connally Breast Center</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Site 41 - The START Center for Cancer Care, South Texas Oncology and Hematology</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78229</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Site 32 - Swedish Medical Center, Swedish Cancer Institute (SCI),Cherry Hill Campus</name>
        <address>
          <city>Seattle</city>
          <state>Washington</state>
          <zip>98122</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Site 81 - Bergonie unicancer, Nouvelle-Aquitaine, L'Institut Bergonie</name>
        <address>
          <city>Bordeaux</city>
          <country>France</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Site 80 - Centre Jean Bernard, Clinique Victor Hugo</name>
        <address>
          <city>Le Mans</city>
          <country>France</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Site 84 - UNICANCER, Centre Leon-Berard (CLB)</name>
        <address>
          <city>Lyon</city>
          <country>France</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Site 83 - Institut Paoli Calmettes (IPC)</name>
        <address>
          <city>Marseille</city>
          <country>France</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Site 85 - Institut Curie</name>
        <address>
          <city>Paris</city>
          <country>France</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Site 82 - Institut de Cancerologie de Ouest (ICO)</name>
        <address>
          <city>Saint-Herblain</city>
          <country>France</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Site 65 - Complexo Hospitalario Universitario A Coruña</name>
        <address>
          <city>A Coruña</city>
          <country>Spain</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Site 64 - Hospital Clinic de Barcelona (Hospital Clinic i Provincial)</name>
        <address>
          <city>Barcelona</city>
          <country>Spain</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Site 68 -Hospital Universitario Vall d'Hebron</name>
        <address>
          <city>Barcelona</city>
          <country>Spain</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Site 61 - Institut Catala d'Oncologia (ICO), Hospital Duran i Reynals Location</name>
        <address>
          <city>L'Hospitalet De Llobregat</city>
          <country>Spain</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Site 62 - Universidad de Navarra, Clinica Universidad de Navarra (CUN)</name>
        <address>
          <city>Madrid</city>
          <country>Spain</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Site 63 - South Texas Accelerated Research Therapeutics, CIOCC, Hospital Madrid Norte-Sanchinarro</name>
        <address>
          <city>Madrid</city>
          <country>Spain</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Site 66 - Hospital Clinico San Carlos</name>
        <address>
          <city>Madrid</city>
          <country>Spain</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Site 69 - Universidad de Navarra - Clinica Universidad de Navarra (CUN)</name>
        <address>
          <city>Pamplona</city>
          <country>Spain</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Site 60 - NEXT Oncology EU Hospital Universitario Quiron Salud Madrid</name>
        <address>
          <city>Pozuelo de Alarcon</city>
          <country>Spain</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Site 67 - Universidad de Sevilla, Hospital Universitario Virgen Macarena</name>
        <address>
          <city>Sevilla</city>
          <country>Spain</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Site 12 - Belfast City Hospital</name>
        <address>
          <city>Belfast</city>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Site 4 - The Christie NHS Foundation Trust</name>
        <address>
          <city>Manchester</city>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Site 13 - Nottingham City Hospital</name>
        <address>
          <city>Nottingham</city>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Site 2 - Oxford University Hospitals NHS Trust - Churchill Hospital</name>
        <address>
          <city>Oxford</city>
          <zip>OX3 7LE</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location_countries>
      <country>France</country>
      <country>Spain</country>
      <country>United Kingdom</country>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Metastatic Breast Cancer</keyword>
    <keyword>Advanced Breast Cancer</keyword>
    <keyword>Breast Cancer</keyword>
    <keyword>HR Positive</keyword>
    <keyword>HER2-Negative</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast 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/NCT05963997
  org study id: CT7001_003
  secondary id: 2023-503846-30-00
  secondary id: 2023-000072-35
  nct id: NCT05963997
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This is an international, multisite, open-label, Phase 1b/2 study, to confirm safety and
        efficacy of samuraciclib in combination with elacestrant in adult participants with
        metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth
        Factor Receptor (HER)2-negative breast cancer.
  This is a multiple cohort study, an initial dose escalation phase is designed to confirm the
        safe dose of samuraciclib in combination with elacestrant. A Safety Review Committee (SRC)
        will monitor the safety, tolerability, and PK data during this phase. Once ascertained, an
        expansion cohort will be opened to explore the efficacy of samuraciclib in combination with
        elacestrant.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Phase 1b (Dose-finding)
  time frame: From the date of first dose of any study intervention (Day 1 Cycle 1) and through 28 days after the last dose of any study intervention
  description: Identification of Samuraciclib + Elacestrant combination, Phase 2, expansion dose level.
  Incidence and severity of adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse events (NCI-CTCAE) v5.0. Safety will be assessed by monitoring treatment - emerged severe and dose limiting adverse events and clinically relevant changes in vital signs and clinical laboratory results
  measure: Phase 2 (Expansion)
  time frame: From the date of first dose of any study intervention (Cycle 1 Day 1) until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)
  description: Progression Free Survival (PFS) is defined as the time from the date of first dose of IMP (Cycle 1 Day 1) to the date of the first documentation of objective progressive disease (PD) or death due to any cause, whichever occurs first.
  measure: Treatment-Emergent Adverse Events and Laboratory Abnormalities (Safety and Tolerability)
  time frame: From the date of first dose of any study intervention through 28 days after the last dose of any study intervention
  description: Type, incidence, severity (as graded by CTCAE v5.0), seriousness and relationship to study medications of AEs and any laboratory abnormalities. Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
  measure: Clinical Benefit Response (CBR)
  time frame: From the date of first dose of any study intervention (Cycle 1 Day 1) to ≥ 24 weeks or until disease progression or death to any cause (assessed up to week 24)
  description: CBR is defined as the overall complete response (CR), partial response (PR), or stable disease (SD) ≥ 24 weeks according to RECIST version 1.1 recorded from enrolment until disease progression, or death due to any cause.
  measure: Overall response rate (ORR)
  time frame: the date of first dose of study intervention (Cycle 1 Day 1) until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)
  description: ORR is defined as the proportion of participants with a reduction in tumor burden with CR or PR according to RECIST version 1.1.
  ORR will be estimated for participants who received at least 1 dose of IMP, had measurable disease at baseline and had a postbaseline tumor assessment.
  measure: Duration of Response (DOR)
  time frame: From the date of first dose of study intervention (Cycle 1 Day 1) until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)
  description: DOR is defined as the time from the date of first documentation of objective tumor response (CR or PR) to the earliest documented disease progression per RECIST version 1.1
  measure: Best percent change in tumor size.
  time frame: From the date of first dose of study intervention (Cycle 1 Day 1) until the first documentation of disease progression, death, withdrawal of consent, or start of new anticancer therapy (assessed up to week 48)
  description: Best percent change in tumor size is defined as the percentage change in the sum of the longest diameters of target lesions
  measure: Samuraciclib plasma exposure: Cmax
  time frame: Day 1 of Cycles 1 and Cycle 2 (each cycle is 28 days)
  description: Plasma concentration for Samuraciclib
  measure: Elacestrant exposure: Cmax
  time frame: Day 1 of Cycles 1 and Cycle 2 (each cycle is 28 days)
  description: Plasma concentrations for Elacestrant
  measure: Samuraciclib plasma exposure: Ctrough
  time frame: Cycle 1 Day 2 and 15; Day 2 of Cycle 2; Day 1 of Cycles 3-6 and end of treatment within 28 days of last dose of IMP and prior to the initiation of a new anticancer therapy (each cycle is 28 days)]
  measure: Elacestrant exposure: Ctrough
  time frame: Cycle 1 Day 2 and Day 15; Cycle 2 Day 2 of Cycle 2 and Day 1 of Cycles 3-6 and at end of treatment within 28 days of the last dose of IMP and prior to the initiation of a new anticancer therapy (each cycle is 28 days)
  measure: Genotyping for ESR1 and TP53 mutations
  time frame: Screening
  description: Genotyping for ESR1 and TP53 mutations to evaluate correlations between ESR1 and TP53 mutations and efficacy/safety findings
  arm group label: Cohort 1
  arm group type: Experimental
  description: Up to 6 evaluable participants will receive samuraciclib 240 mg in combination with elacestrant 300 mg in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards).
  arm group label: Cohort 2
  arm group type: Experimental
  description: Up to 6 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 300 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward).
  arm group label: Cohort 3
  arm group type: Experimental
  description: Up to 6 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 400 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward).
  arm group label: Cohort 4 Expansion
  arm group type: Experimental
  description: Up to 30 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 400 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward).
  intervention type: Drug
  intervention name: Samuraciclib
  description: Samuraciclib capsules by mouth once a day
  arm group label: Cohort 1
  arm group label: Cohort 2
  arm group label: Cohort 3
  arm group label: Cohort 4 Expansion
  intervention type: Drug
  intervention name: Elacestrant Dihydrochloride
  description: Elacestrant tablets by mouth once a day
  arm group label: Cohort 1
  arm group label: Cohort 2
  arm group label: Cohort 3
  arm group label: Cohort 4 Expansion
  other name: ORSERDU
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Clinical Operations
  phone: +353 1 5996873
  email: hello@carricktherapeutics.com
  facility: 
  status: Recruiting
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  country: France
  country: Spain
  country: United Kingdom
  country: United States
  responsible party type: Sponsor
  mesh term: Breast Neoplasms