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LY3295668 Erbumine

Phase 1

Metastatic Breast Cancer | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Aug 21, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment5

FDA Designations

No designations recorded

Clinical trial landscape

LY3295668 Erbumine · 3 trials · 3 indications

Phase 1 3
NCT04106219A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory NeuroblastomaNeuroblastoma
ACTIVE NOT_RECRUITING71 Analytics
NCT03955939A Study of LY3295668 Erbumine in Participants With Breast Cancer That Has Spread to Other Parts of the BodyMetastatic Breast Cancer
COMPLETED5 Analytics
NCT03898791A Study of LY3295668 Erbumine in Participants With Extensive-stage Small-Cell Lung CancerSmall Cell Lung Cancer
COMPLETED48 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma
NeuroblastomaUnlock trial analytics
PHASE1COMPLETED
A Study of LY3295668 Erbumine in Participants With Breast Cancer That Has Spread to Other Parts of the Body
Metastatic Breast CancerUnlock trial analytics
PHASE1COMPLETED
A Study of LY3295668 Erbumine in Participants With Extensive-stage Small-Cell Lung Cancer
Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with Dose Limiting Toxicities (DLTs)
Baseline through Cycle 2 (28 Day Cycle)

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 5 Years)

ORR

Duration of Response (DoR)
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 5 Years)

DoR

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

Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
Baseline through Measured Progressive Disease (Estimated up to 20 Months)

ORR: Percentage of participants who achieve CR or PR

Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668 Erbumine
Predose Cyce 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)

PK: AUC of LY3295668 Erbumine

Secondary Endpoints

Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668
Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles)
PK: AUC of LY3295668 in Combination with Topotecan and Cyclophosphamide
Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles)
Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD)
Baseline to Date of Objective Disease Progression (Estimated up to 5 Years)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LY3295668 Erbumine EscalationEXPERIMENTALLY3295668 Erbumine given orally.
LY3295668 Erbumine + Topotecan + Cyclophosphamide EscalationEXPERIMENTALLY3295668 Erbumine given orally and topotecan and cyclophosphamide given intravenously (IV).
LY3295668 Erbumine ExpansionEXPERIMENTALLY3295668 Erbumine given orally.
LY3295668 Erbumine + Topotecan + Cyclophosphamide ExpansionEXPERIMENTALLY3295668 Erbumine given orally and topotecan and cyclophosphamide given IV.
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).
LY3295668 Erbumine Cohort AEXPERIMENTALLY3295668 erbumine administered orally.
LY3295668 Erbumine Cohort BEXPERIMENTALLY3295668 erbumine administered orally.
LY3295668 Part JPEXPERIMENTALLY3295668 erbumine administered orally.

Interventions

NameTypeDescription
LY3295668 ErbumineDRUGAdministered orally.
TopotecanDRUGAdministered IV.
CyclophosphamideDRUGAdministered IV.
Endocrine therapyDRUGAdministered according to label instructions.
MidazolamDRUGAdministered orally.
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Eligibility Criteria

Age Range2 Years to 21 Years
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Participants must have relapsed/refractory neuroblastoma and have active disease in at least one site: bone, bone marrow or soft tissue. Participants must be able to submit an archival sample of tissue. * Participants must be able to swallow capsules. Exclusion Criteria: * P...

Countries:United StatesAustraliaBelgiumFranceGermanyItalyJapanSpainUnited KingdomSouth KoreaTurkey (Türkiye)
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Competitive Landscape -Breast Cancer 402 trials (matched to "Metastatic Breast Cancer")

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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Recent Changes (Last 90 Days)

MEDIUMAug 21, 2026NCT04106219Completion: 2026-08 → 2027-08
MEDIUMAug 21, 2026NCT04106219Completion: 2026-08 → 2027-08

Frequently asked questions about LY3295668 Erbumine

What is LY3295668 Erbumine used for?

LY3295668 Erbumine is an investigational small molecule being studied for the treatment of metastatic breast cancer, neuroblastoma, and small cell lung cancer. It is in Phase 1 clinical development for these oncology indications.

Who makes LY3295668 Erbumine?

LY3295668 Erbumine is being developed by Eli Lilly and Company, which trades under the ticker symbol LLY on the stock exchange.

What phase is LY3295668 Erbumine in?

LY3295668 Erbumine is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing or completed to evaluate its safety and efficacy.

What clinical trials is LY3295668 Erbumine in?

LY3295668 Erbumine has been studied in three Phase 1 trials: NCT03898791 in extensive-stage small-cell lung cancer, NCT03955939 in metastatic breast cancer, and NCT04106219 in relapsed/refractory neuroblastoma. These trials are completed or active but not recruiting.

Is LY3295668 Erbumine the same as any other drug?

LY3295668 Erbumine is the specific drug name used in clinical trials. No alternative names have been reported for this compound in the available clinical trial information.