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A Study of LY3405105 in Participants With Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03770494
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: LY3405105 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1a/1b Study of LY3405105 Administered to Patients With Advanced Solid Tumors
Actual Study Start Date : January 31, 2019
Estimated Primary Completion Date : May 5, 2022
Estimated Study Completion Date : May 5, 2022

Arm Intervention/treatment
Experimental: LY3405105
LY3405105 administered orally.
Drug: LY3405105
Administered orally.




Primary Outcome Measures :
  1. Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline through Cycle 1 (28 Day Cycle) ]
    Number of participants with DLTs


Secondary Outcome Measures :
  1. 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) ]
    PK: AUC of LY3405105

  2. 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) ]
    ORR: Percentage of participants with a Confirmed CR or PR

  3. 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) ]
    DCR: Percentage of participants who exhibit SD, Confirmed CR or PR

  4. 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) ]
    DOR

  5. Time to Response (TTR) [ Time Frame: Baseline to Date of Confirmed CR or PR (Estimated up to 6 Months) ]
    TTR

  6. Progression Free Survival (PFS) [ Time Frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 12 Months) ]
    PFS

  7. Overall Survival (OS) [ Time Frame: Baseline to Date of Death from Any Cause (Estimated up to 12 Months) ]
    OS



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Phase 1 a:

  • Have histological or cytological evidence of a diagnosis of a solid tumor cancer that is advanced and/or metastatic
  • Have available archived tissue for exploratory biomarker analysis
  • Have adequate organ function
  • Have discontinued all previous treatments for cancer and recovered from their side effects
  • Are able to swallow capsules/tablets

Phase 1 b:

  • Cohort 1: Triple-negative breast cancer (TNBC).
  • Cohort 2: Clear cell ovarian cancer, endometrioid ovarian cancer, or endometrioid endometrial carcinoma with a LOF mutation in one or more of the following genes: ARID1A, KMT2C (MLL3), KMT2D (MLL2), or KDM6A (UTX).
  • Cohort 3: Soft tissue sarcoma or sarcomatoid/rhabdoid malignancy with loss of expression of INI1, BRG1, or BRM by immunohistochemistry or a LOF mutation in one or more of the following genes: ARID1A, SMARCA2, SMARCA4, or SMARCB1. Participants aged ≥ 12 years with a body weight of ≥ 40 kilogram (kg) are acceptable for Cohorts 3. Participants with synovial sarcoma and a confirmed SS18-SSX gene fusion are also eligible.
  • Cohort 4: Epithelioid sarcoma with INI1 loss of expression by immunohistochemistry or SMARCB1 LOF mutation. Participants aged ≥ 12 years with a body weight of ≥ 40 kilogram (kg) are acceptable for Cohorts 4.
  • Cohort 5: Bladder cancer with a LOF mutation in one or more of the following genes: ARID1A, KMT2C (MLL3), KMT2D (MLL2), or KDM6A (UTX).

Exclusion Criteria:

  • Have symptomatic central nervous system (CNS) malignancy or metastasis
  • Have symptomatic human immunodeficiency virus (HIV), Hepatitis A, B, or C
  • Have congestive heart failure
  • Are breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03770494


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 clinicaltrials.gov@lilly.com

Locations
Show Show 19 study locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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) Eli Lilly and Company
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03770494    
Other Study ID Numbers: 17125
J1F-MC-JZFA ( Other Identifier: Eli Lilly and Company )
2018-002668-23 ( EudraCT Number )
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No