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.
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
Interventions
Drug | Synonyms | Arms |
---|
LY3405105 | | LY3405105 |
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
Name | Type | Description | Interventions |
---|
LY3405105 | Experimental | LY3405105 administered orally. | |
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: | Completed |
Lead Sponsor: | Eli Lilly and Company |
Last Updated
March 18, 2021