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LY3295668 Erbumine

Phase 1

Metastatic Breast Cancer | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Jun 1, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment5
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03955939A Study of LY3295668 Erbumine in Participants With Breast Cancer That Has Spread to Other Parts of the BodyPHASE1 COMPLETED 5 — — Aug 2, 2019May 14, 2020Jun 1, 20207 United States, Belgium
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Study Endpoints
Primary Endpoints
Number of Participants with Dose Reductions
Baseline through Cycle 1 (28 Day Cycle)
Part II: Number of Participants with Dose Limiting Toxicities (DLTs)
Baseline through Cycle 1 (28 Day Cycle)

Part II: Number of Participants with DLTs

Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
Baseline through Measured Progressive Disease (Estimated up to 23 Months)

ORR

Duration of Response (DoR)
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 23 Months)

DoR

Secondary Endpoints
Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve CR, PR or SD With a Duration of At Least 6 Months
Baseline through Disease Progression or Death Due to Any Cause (Estimated up to 23 Months)
Progression-Free Survival (PFS)
Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 23 Months)
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668
Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY3295668 Erbumine Part AEXPERIMENTALLY3295668 erbumine administered orally (Part I). Approximately the first 10 participants enrolled in this arm will be administered midazolam.
LY3295668 Erbumine Part BEXPERIMENTALLY3295668 erbumine administered orally (Part I). Approximately the first 10 participants enrolled in this arm will be administered midazolam.
LY3295668 Erbumine + Endocrine Therapy Cohort 1EXPERIMENTALLY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part II).
LY3295668 Erbumine + Endocrine Therapy Continuation Part CEXPERIMENTALLY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I).
LY3295668 Erbumine + Endocrine Therapy Switch Part DEXPERIMENTALLY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I).
Interventions
NameTypeDescription
LY3295668 ErbumineDRUGAdministered orally.
Endocrine therapyDRUGAdministered according to label instructions.
MidazolamDRUGAdministered orally.
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Participant must have hormone receptor positive and HER2 negative metastatic breast cancer * Participant must have progressed on at least 1 line of endocrine therapy and 1 cyclin dependent kinase (CDK)4/6 inhibitor * Participant must be able and willing to undergo mandatory tu...

Countries:United StatesBelgium
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Competitive Landscape -Breast Cancer 408 trials
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