A Study of LY3405105 in Participants With Advanced Cancer
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|ClinicalTrials.gov Identifier: NCT03770494|
Recruitment Status : Terminated (The study was terminated for lack of sufficient efficacy.)
First Posted : December 10, 2018
Last Update Posted : November 8, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: LY3405105||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1a/1b Study of LY3405105 Administered to Patients With Advanced Solid Tumors|
|Actual Study Start Date :||January 31, 2019|
|Actual Primary Completion Date :||February 4, 2021|
|Actual Study Completion Date :||February 4, 2021|
LY3405105 administered orally.
- Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline through Cycle 1 (28 Day Cycle) ]Number of participants with DLTs
- Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3405105 [ Time Frame: 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) [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 6 Months) ]ORR: Percentage of participants with a Confirmed CR or PR
- Disease Control Rate (DCR): Percentage of Participants who Exhibit Stable Disease (SD), Confirmed CR or PR [ Time Frame: Baseline through Measured Progressive Disease (Estimated up to 6 Months) ]DCR: Percentage of participants who exhibit SD, Confirmed CR or PR
- Duration of Response (DOR) [ Time Frame: Date of Confirmed CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months) ]DOR
- Time to Response (TTR) [ Time Frame: Baseline to Date of Confirmed CR or PR (Estimated up to 6 Months) ]TTR
- Progression Free Survival (PFS) [ Time Frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 12 Months) ]PFS
- Overall Survival (OS) [ Time Frame: Baseline to Date of Death from Any Cause (Estimated up to 12 Months) ]OS
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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).
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03770494
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Eli Lilly and Company|
|Other Study ID Numbers:||
J1F-MC-JZFA ( Other Identifier: Eli Lilly and Company )
2018-002668-23 ( EudraCT Number )
|First Posted:||December 10, 2018 Key Record Dates|
|Last Update Posted:||November 8, 2021|
|Last Verified:||November 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|