A Study of LY3405105 in Participants With Advanced Cancer

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03770494
• Other study ID #: 17125
• Secondary ID: J1F-MC-JZFA2018-
• Status: Terminated
• Phase: Phase 1
• Start date: January 31, 2019
• Est. completion date: February 4, 2021

Study information

• Verified date: November 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: February 4, 2021
• Est. primary completion date: February 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Drug:
• LY3405105
Administered orally.

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario
France	Institut Bergonie	Bordeaux
France	Institut Curie	Paris
France	Gustave Roussy	Villejuif Cedex
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Madrid Norte Sanchinarro	Madrid
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Cheng-Kung Uni. Hosp.	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
United States	Duke University Medical Center	Durham	North Carolina
United States	Highlands Oncology Group	Fayetteville	Arkansas
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
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	University of Pennsylvania Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Canada,  France,  Spain,  Taiwan, 

Outcome

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

External Links

•   A Study of LY3405105 in Participants With Advanced Cancer