Clinical Trials /

A Study of LY3405105 in Participants With Advanced Cancer

NCT03770494

Description:

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.

Related Conditions:
  • Bladder Carcinoma
  • Breast Carcinoma
  • Endometrial Endometrioid Adenocarcinoma
  • Epithelioid Sarcoma
  • Malignant Ovarian Clear Cell Tumor
  • Malignant Ovarian Endometrioid Tumor
  • Malignant Solid Tumor
  • Rhabdoid Tumor
  • Sarcomatoid Carcinoma
  • Soft Tissue Sarcoma
  • Synovial Sarcoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of LY3405105 in Participants With Advanced Cancer
  • Official Title: A Phase 1a/1b Study of LY3405105 Administered to Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: 17125
  • SECONDARY ID: J1F-MC-JZFA
  • SECONDARY ID: 2018-002668-23
  • NCT ID: NCT03770494

Conditions

  • Solid Tumor

Interventions

DrugSynonymsArms
LY3405105LY3405105

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
LY3405105ExperimentalLY3405105 administered orally.
  • LY3405105

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with Dose Limiting Toxicities (DLTs)
Time Frame:Baseline through Cycle 1 (28 Day Cycle)
Safety Issue:
Description:Number of participants with DLTs

Secondary Outcome Measures

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)
Safety Issue:
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)
Safety Issue:
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)
Safety Issue:
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)
Safety Issue:
Description:DOR
Measure:Time to Response (TTR)
Time Frame:Baseline to Date of Confirmed CR or PR (Estimated up to 6 Months)
Safety Issue:
Description:TTR
Measure:Progression Free Survival (PFS)
Time Frame:Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)
Safety Issue:
Description:PFS
Measure:Overall Survival (OS)
Time Frame:Baseline to Date of Death from Any Cause (Estimated up to 12 Months)
Safety Issue:
Description:OS

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Eli Lilly and Company

Last Updated

September 17, 2020