A Phase 1a/1b Study of LY3405105 Administered to Patients With Advanced Solid Tumors

Status: Terminated
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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).

Locations
United States
Arkansas
Highlands Oncology Group
Fayetteville
Connecticut
Smilow Cancer Hospital at Yale-New Haven
New Haven
North Carolina
Duke University Medical Center
Durham
New York
Columbia University Medical Center
New York
Memorial Sloan Kettering Cancer Center
New York
Pennsylvania
University of Pennsylvania Hospital
Philadelphia
Texas
University of Texas MD Anderson Cancer Center
Houston
Other Locations
Canada
Princess Margaret Hospital
Toronto
France
Institut Bergonie
Bordeaux
Institut Curie
Paris
Gustave Roussy
Villejuif Cedex
Spain
Hospital Universitari Vall d'Hebron
Barcelona
Hospital Madrid Norte Sanchinarro
Madrid
Taiwan
Taichung Veterans General Hospital
Taichung
National Cheng-Kung Uni. Hosp.
Tainan
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Time Frame
Start Date: January 31, 2019
Completion Date: February 4, 2021
Participants
Target number of participants: 54
Treatments
Experimental: LY3405105
LY3405105 administered orally.
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov

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