Status:
TERMINATED
A Study of LY3405105 in Participants With Advanced Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2021
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03770494
Start Date
January 31 2019
End Date
February 4 2021
Last Update
November 4 2025
Active Locations (17)
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1
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
2
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, United States, 06511
3
Columbia University Medical Center
New York, New York, United States, 10032
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065