A Study of LY3405105 in Participants With Advanced Cancer

Phase 1

Terminated

• Conditions: Solid Tumor
• Interventions: Drug: LY3405105

• Registration Number: NCT03770494
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-07
• Study First Submitted QC: 2018-12-07
• Study First Posted: 2018-12-10
• Study Start: 2019-01-31
• Primary Completion: 2021-02-04
• Study Completion: 2021-02-04
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-03
• Last Update Posted: 2021-11-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LY3405105	LY3405105	LY3405105 administered orally.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Dose Limiting Toxicities (DLTs)	Baseline through Cycle 1 (28 Day Cycle)	Number of participants with DLTs

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)	PFS
Overall Survival (OS)	Baseline to Date of Death from Any Cause (Estimated up to 12 Months)	OS
Disease Control Rate (DCR): Percentage of Participants who Exhibit Stable Disease (SD), Confirmed CR or PR	Baseline through Measured Progressive Disease (Estimated up to 6 Months)	DCR: Percentage of participants who exhibit SD, Confirmed CR or PR
Time to Response (TTR)	Baseline to Date of Confirmed CR or PR (Estimated up to 6 Months)	TTR
Duration of Response (DOR)	Date of Confirmed CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)	DOR
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3405105	Predose Lead in Day 1 through Predose Cycle 2 Day 1 (28 Day Cycles)	PK: AUC of LY3405105
Objective Response Rate (ORR): Percentage of Participants with a Confirmed Complete Response (CR) or Partial Response (PR)	Baseline through Measured Progressive Disease (Estimated up to 6 Months)	ORR: Percentage of participants with a Confirmed CR or PR

Trial Locations

Locations (17)

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

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