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LY4257496

Phase 1

Breast Neoplasms | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Jun 3, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment421
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07114601A Study of LY4257496 in Participants With Cancer (OMNIRAY)PHASE1 RECRUITING 421 — — Aug 6, 2025Apr 1, 2035Jun 3, 202630 United States, Canada +5
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Study Endpoints
Primary Endpoints
Phase 1a Dose Escalation: Maximum Tolerated Dose of LY4257496
From Cycle 1 Day 1 (C1D1) through 28 days after the first dose of study drug. Cycle = 28 days
Phase 1a Dose Optimization: Number of Dose Limiting Toxicities of LY4257496
From Cycle 1 Day 1 (C1D1) through 28 days after the first dose of study drug. Cycle = 28 days
Phase 1b Dose Expansion and Optimization: Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR)
From C1D1 through efficacy follow-up, estimated as Week 42. Cycle = 42 weeks
Secondary Endpoints
Phase 1a Dose Escalation and Optimization: ORR: Percentage of Participants with Best Response of CR or PR
From C1D1 through efficacy follow-up, estimated as Week 42. Cycle = 42 weeks
Phase 1a Dose Escalation: Absorbed Dose Estimates (Gray (Gy)) of LY4257496 in Normal Organs
From C1D1 through 30 days after the last dose of study drug dose. Cycle = 30 days
Phase 1a Dose Escalation and Optimization: Absorbed Dose Estimates (Gy) of LY4257529 in Normal Organs
From end of injection at Screening, and at Day 30 through 1 day after injection
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY4257496 Phase 1a Dose Escalation (Cohort A1)EXPERIMENTALLY4257496 administered intravenously (IV)
LY4257496 Phase 1a Dose Optimization (Cohort A2)EXPERIMENTALLY4257496 administered IV
LY4257496 + Standard of Care Phase 1b Cohort BEXPERIMENTALTumor specific cohort will receive LY4257496 alone or with standard of care anticancer therapy(ies)
LY4257496 Phase 1b Cohort CEXPERIMENTALTumor specific cohort will receive LY4257496
LY4257496 Phase 1b Cohort DEXPERIMENTALTumor specific cohort will receive LY4257496
Interventions
NameTypeDescription
LY4257496DRUGAdministered IV
Standard of Care Anticancer TherapiesDRUGFulvestrant, Imlunestrant, Aromatase Inhibitors, Capecitabine, Abemaciclib
LY4257529DIAGNOSTIC_TESTAdministered IV at select sites
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites30

Inclusion Criteria: * Must have histologically or cytologically proven diagnosis of locally advanced, unresectable, or metastatic cancer. * Must be assessed by computed tomography (CT)/magnetic resonance imaging (MRI) to confirm at least 1 of the following: * At least 1 measurable target lesion ...

Countries:United StatesCanadaChinaFranceGermanyJapanSpain
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Recent Changes (Last 90 Days)
LOWJun 3, 2026NCT07114601lastUpdatePostDate: changed
LOWJun 3, 2026NCT07114601lastUpdatePostDate: changed
LOWMay 29, 2026NCT07114601lastUpdatePostDate: changed
LOWMay 29, 2026NCT07114601lastUpdatePostDate: changed
LOWMay 26, 2026NCT07114601primaryCompletionDate: changed
LOWMay 24, 2026NCT07114601studyFirstPostDate: changed