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LY4170156

Phase 1

Ovarian Neoplasms | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Jan 14, 2026

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
RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment495
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06400472A Study of LY4170156 in Participants With Selected Advanced Solid TumorsPHASE1 RECRUITING 495May 20, 2024Apr 1, 2027Jan 14, 202623 United States, Australia +5
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Study Endpoints
Primary Endpoints
Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY4170156
1 Cycle (21 days)

Number of participants with dose-limiting toxicities (DLTs)

Phase 1a: To determine the RP2D or optimal dose of LY4170156 with bevacizumab
1 Cycle (21 days)

Number of participants with DLTs

Phase 1a: To determine the RP2D or optimal dose of LY4170156 with carboplatin
1 Cycle (21 days)

Number of participants with DLTs

Phase 1a: To determine the RP2D or optimal dose of LY4170156 with pembrolizumab
1 Cycle (21 days)

Number of participants with DLTs

Phase 1b: To assess the antitumor activity of LY4170156 Monotherapy: Overall response rate (ORR)
Up to Approximately 48 Months or 4 Years

ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Up to Approximately 48 Months or 4 Years

A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module

Secondary Endpoints
To characterize the pharmacokinetics (PK) properties of LY4170156: Minimum Plasma Concentration (Cmin)
First 4 Cycles (84 days)
To characterize the PK properties of LY4170156: Cmin with bevacizumab or carboplatin
First 4 Cycles (Approximately 84 days)
To characterize the PK properties of LY4170156: Cmin with pembrolizumab
First 4 Cycles (84 days)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY4170156 (Dose-escalation, Cohort A1)EXPERIMENTALEscalating doses of LY4170156 administered intravenously (IV)
LY4170156 (Cohort A1 Parts A and C)EXPERIMENTALLY4170156 administered IV
LY4170156 Alone or with Itraconazole. Drug-Drug Interaction (DDI) (Cohort A1: Arm B)EXPERIMENTALLY4170156 administered IV and itraconazole administered orally
LY4170156 (Dose-optimization, Cohort A2)EXPERIMENTALComparing 2 or more doses (evaluated during dose escalation) of LY4170156 administered IV
LY4170156 (Enrichment Cohort A3)EXPERIMENTALMonotherapy administered IV
LY4170156 (Combination Cohort A4)EXPERIMENTALCombination with bevacizumab administered IV
LY4170156 (Combination Cohort A5)EXPERIMENTALCombination with carboplatin administered IV
LY4170156 Combination with Pembrolizumab (Dose-optimization Cohort A6)EXPERIMENTALComparing 2 or more doses (evaluated during dose escalation) of LY4170156 administered IV with pembrolizumab
LY4170156 (Dose-expansion, Cohort B1-B4)EXPERIMENTALLY4170156 administered IV
Interventions
NameTypeDescription
LY4170156DRUGIntravenous
bevacizumabDRUGIV
carboplatinDRUGIV
ItraconazoleDRUGoral
pembrolizumabDRUGIV
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: * Have one of the following solid tumor cancers: * Dose Escalation: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) cancer, endometrial cancer, cervical cancer, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), pancreatic cancer, o...

Countries:United StatesAustraliaFranceItalyJapanSouth KoreaSpain
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06400472primaryCompletionDate: changed
LOWMay 24, 2026NCT06400472studyFirstPostDate: changed