A Study of LY3405105 in Participants With Advanced Cancer

Stopped early · Phase 1

Conditions studied: Solid Tumor

In brief

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.

Key facts

Study ID

NCT03770494

Run by

Eli Lilly and Company

People needed

54

Starts

2019-01-31

Expected to finish

2021-02-04

Last updated by the study team

2025-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Highlands Oncology Group — Fayetteville, Arkansas, United States
• Smilow Cancer Hospital at Yale-New Haven — New Haven, Connecticut, United States
• Columbia University Medical Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Princess Margaret Hospital — Toronto, Ontario, Canada
• Institut Bergonie — Bordeaux, France
• Institut Curie — Paris, France
• Gustave Roussy — Villejuif, France
• Hospital Universitari Vall d'Hebron — Barcelona, Spain
• Hospital Madrid Norte Sanchinarro — Madrid, Spain
• Taichung Veterans General Hospital — Taichung, Taiwan
• National Cheng-Kung Uni. Hosp. — Tainan, Taiwan
• National Taiwan University Hospital — Taipei, Taiwan
• Taipei Veterans General Hospital — Taipei, Taiwan

Full record on ClinicalTrials.gov

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