<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/NCT03770494</url>
  </required_header>
  <id_info>
    <org_study_id>17125</org_study_id>
    <secondary_id>J1F-MC-JZFA</secondary_id>
    <secondary_id>2018-002668-23</secondary_id>
    <nct_id>NCT03770494</nct_id>
  </id_info>
  <brief_title>A Study of LY3405105 in Participants With Advanced Cancer</brief_title>
  <official_title>A Phase 1a/1b Study of LY3405105 Administered to Patients With Advanced Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to investigate the safety of LY3405105 in participants with&#xD;
      advanced cancer. The study has two parts phase 1a and phase 1b. Participants will only enroll&#xD;
      in one part.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was terminated for lack of sufficient efficacy.&#xD;
  </why_stopped>
  <start_date type="Actual">January 31, 2019</start_date>
  <completion_date type="Actual">February 4, 2021</completion_date>
  <primary_completion_date type="Actual">February 4, 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Dose Limiting Toxicities (DLTs)</measure>
    <time_frame>Baseline through Cycle 1 (28 Day Cycle)</time_frame>
    <description>Number of participants with DLTs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3405105</measure>
    <time_frame>Predose Lead in Day 1 through Predose Cycle 2 Day 1 (28 Day Cycles)</time_frame>
    <description>PK: AUC of LY3405105</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR): Percentage of Participants with a Confirmed Complete Response (CR) or Partial Response (PR)</measure>
    <time_frame>Baseline through Measured Progressive Disease (Estimated up to 6 Months)</time_frame>
    <description>ORR: Percentage of participants with a Confirmed CR or PR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR): Percentage of Participants who Exhibit Stable Disease (SD), Confirmed CR or PR</measure>
    <time_frame>Baseline through Measured Progressive Disease (Estimated up to 6 Months)</time_frame>
    <description>DCR: Percentage of participants who exhibit SD, Confirmed CR or PR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>Date of Confirmed CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)</time_frame>
    <description>DOR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Response (TTR)</measure>
    <time_frame>Baseline to Date of Confirmed CR or PR (Estimated up to 6 Months)</time_frame>
    <description>TTR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)</time_frame>
    <description>PFS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Baseline to Date of Death from Any Cause (Estimated up to 12 Months)</time_frame>
    <description>OS</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Solid Tumor</condition>
  <arm_group>
    <arm_group_label>LY3405105</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LY3405105 administered orally.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY3405105</intervention_name>
    <description>Administered orally.</description>
    <arm_group_label>LY3405105</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Phase 1 a:&#xD;
&#xD;
          -  Have histological or cytological evidence of a diagnosis of a solid tumor cancer that&#xD;
             is advanced and/or metastatic&#xD;
&#xD;
          -  Have available archived tissue for exploratory biomarker analysis&#xD;
&#xD;
          -  Have adequate organ function&#xD;
&#xD;
          -  Have discontinued all previous treatments for cancer and recovered from their side&#xD;
             effects&#xD;
&#xD;
          -  Are able to swallow capsules/tablets&#xD;
&#xD;
        Phase 1 b:&#xD;
&#xD;
          -  Cohort 1: Triple-negative breast cancer (TNBC).&#xD;
&#xD;
          -  Cohort 2: Clear cell ovarian cancer, endometrioid ovarian cancer, or endometrioid&#xD;
             endometrial carcinoma with a LOF mutation in one or more of the following genes:&#xD;
             ARID1A, KMT2C (MLL3), KMT2D (MLL2), or KDM6A (UTX).&#xD;
&#xD;
          -  Cohort 3: Soft tissue sarcoma or sarcomatoid/rhabdoid malignancy with loss of&#xD;
             expression of INI1, BRG1, or BRM by immunohistochemistry or a LOF mutation in one or&#xD;
             more of the following genes: ARID1A, SMARCA2, SMARCA4, or SMARCB1. Participants aged ≥&#xD;
             12 years with a body weight of ≥ 40 kilogram (kg) are acceptable for Cohorts 3.&#xD;
             Participants with synovial sarcoma and a confirmed SS18-SSX gene fusion are also&#xD;
             eligible.&#xD;
&#xD;
          -  Cohort 4: Epithelioid sarcoma with INI1 loss of expression by immunohistochemistry or&#xD;
             SMARCB1 LOF mutation. Participants aged ≥ 12 years with a body weight of ≥ 40 kilogram&#xD;
             (kg) are acceptable for Cohorts 4.&#xD;
&#xD;
          -  Cohort 5: Bladder cancer with a LOF mutation in one or more of the following genes:&#xD;
             ARID1A, KMT2C (MLL3), KMT2D (MLL2), or KDM6A (UTX).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have symptomatic central nervous system (CNS) malignancy or metastasis&#xD;
&#xD;
          -  Have symptomatic human immunodeficiency virus (HIV), Hepatitis A, B, or C&#xD;
&#xD;
          -  Have congestive heart failure&#xD;
&#xD;
          -  Are breastfeeding&#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>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Highlands Oncology Group</name>
      <address>
        <city>Fayetteville</city>
        <state>Arkansas</state>
        <zip>72703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Smilow Cancer Hospital at Yale-New Haven</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5TY 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Bergonie</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Curie</name>
      <address>
        <city>Paris</city>
        <zip>75248</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gustave Roussy</name>
      <address>
        <city>Villejuif Cedex</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Madrid Norte Sanchinarro</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cheng-Kung Uni. Hosp.</name>
      <address>
        <city>Tainan</city>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>10048</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Italy</country>
    <country>United Kingdom</country>
  </removed_countries>
  <link>
    <url>https://trials.lillytrialguide.com/en-US/trial/ISkx1UpFmMIUiQYaemQSE</url>
    <description>A Study of LY3405105 in Participants With Advanced Cancer</description>
  </link>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>November 3, 2021</last_update_submitted>
  <last_update_submitted_qc>November 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03770494
org study id: 17125
secondary id: J1F-MC-JZFA
secondary id: 2018-002668-23
nct id: NCT03770494
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The main purpose of this study is to investigate the safety of LY3405105 in participants with
      advanced cancer. The study has two parts phase 1a and phase 1b. Participants will only enroll
      in one part.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants with Dose Limiting Toxicities (DLTs)
time frame: Baseline through Cycle 1 (28 Day Cycle)
description: Number of participants with DLTs
measure: Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3405105
time frame: Predose Lead in Day 1 through Predose Cycle 2 Day 1 (28 Day Cycles)
description: PK: AUC of LY3405105
measure: Objective Response Rate (ORR): Percentage of Participants with a Confirmed Complete Response (CR) or Partial Response (PR)
time frame: Baseline through Measured Progressive Disease (Estimated up to 6 Months)
description: ORR: Percentage of participants with a Confirmed CR or PR
measure: Disease Control Rate (DCR): Percentage of Participants who Exhibit Stable Disease (SD), Confirmed CR or PR
time frame: Baseline through Measured Progressive Disease (Estimated up to 6 Months)
description: DCR: Percentage of participants who exhibit SD, Confirmed CR or PR
measure: Duration of Response (DOR)
time frame: Date of Confirmed CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)
description: DOR
measure: Time to Response (TTR)
time frame: Baseline to Date of Confirmed CR or PR (Estimated up to 6 Months)
description: TTR
measure: Progression Free Survival (PFS)
time frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)
description: PFS
measure: Overall Survival (OS)
time frame: Baseline to Date of Death from Any Cause (Estimated up to 12 Months)
description: OS
arm group label: LY3405105
arm group type: Experimental
description: LY3405105 administered orally.
intervention type: Drug
intervention name: LY3405105
description: Administered orally.
arm group label: LY3405105
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
facility: 
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country: Canada
country: France
country: Spain
country: Taiwan
country: United States
country: Italy
country: United Kingdom
url: https://trials.lillytrialguide.com/en-US/trial/ISkx1UpFmMIUiQYaemQSE
description: A Study of LY3405105 in Participants With Advanced Cancer
responsible party type: Sponsor
sharing ipd: No