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LY4257496

Phase 1

Breast Neoplasms | Small molecule | Oncology |Eli Lilly and Company|Trials Updated: Oct 7, 2026

LY4257496 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment421

FDA Designations

No designations recorded

LY4257496 clinical trials

LY4257496 · 1 trial · 7 indications

Phase 1 1
NCT07114601A Study of LY4257496 in Participants With Cancer (OMNIRAY)Breast Neoplasms
RECRUITING421 Analytics
PHASE1RECRUITING
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast NeoplasmsUnlock trial analytics

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 to N/A
SexALL
Healthy VolunteersNo
Study Sites33

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)

LOWOct 7, 2026NCT07114601lastUpdatePostDate: changed
LOWOct 7, 2026NCT07114601lastUpdatePostDate: changed
LOWSep 22, 2026NCT07114601lastUpdatePostDate: changed
LOWSep 22, 2026NCT07114601lastUpdatePostDate: changed
LOWSep 4, 2026NCT07114601lastUpdatePostDate: changed
LOWSep 4, 2026NCT07114601lastUpdatePostDate: changed
LOWAug 21, 2026NCT07114601lastUpdatePostDate: changed
LOWAug 21, 2026NCT07114601lastUpdatePostDate: changed
LOWAug 6, 2026NCT07114601lastUpdatePostDate: changed
LOWAug 6, 2026NCT07114601lastUpdatePostDate: changed

Frequently asked questions about LY4257496

What is LY4257496 used for?

LY4257496 is an investigational small molecule being studied for the treatment of breast neoplasms and other advanced solid tumors. It is in Phase 1 clinical development and has not been approved for any indication. Eli Lilly and Company is evaluating it in a study that also includes colorectal, prostate, endometrial, stomach, and esophageal cancers.

Who is developing LY4257496?

LY4257496 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. The company is the sole sponsor of the Phase 1 OMNIRAY study evaluating the compound in participants with cancer.

What phase is LY4257496 in?

LY4257496 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. The only registered trial is a Phase 1 study that is currently recruiting participants.

What clinical trials is LY4257496 in?

LY4257496 is being evaluated in one clinical trial, NCT07114601, titled A Study of LY4257496 in Participants With Cancer (OMNIRAY). The Phase 1 trial is recruiting and plans to enroll 421 participants across the United States, Canada, China, France, Germany, Japan, and Spain.

Is LY4257496 biomarker selected?

Yes, the Phase 1 OMNIRAY trial of LY4257496 is biomarker selected, meaning enrollment is guided by specific molecular characteristics. The study is controlled and enrolls adults 18 years and older with breast neoplasms, colorectal neoplasms, prostate neoplasm, endometrial neoplasms, neoplasm metastasis, stomach neoplasms, or esophageal neoplasms.