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LY4257496

Phase 1

Breast Neoplasms | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Sep 4, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment421

FDA Designations

No designations recorded

Clinical trial landscape

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)

LOWAug 21, 2026NCT07114601lastUpdatePostDate: changed
LOWAug 21, 2026NCT07114601lastUpdatePostDate: changed
LOWAug 6, 2026NCT07114601lastUpdatePostDate: changed
LOWAug 6, 2026NCT07114601lastUpdatePostDate: changed
LOWJul 20, 2026NCT07114601lastUpdatePostDate: changed
LOWJul 20, 2026NCT07114601lastUpdatePostDate: changed
LOWJul 7, 2026NCT07114601lastUpdatePostDate: changed
LOWJul 7, 2026NCT07114601lastUpdatePostDate: changed
LOWJun 23, 2026NCT07114601lastUpdatePostDate: changed
LOWJun 23, 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, as well as other cancers including colorectal, prostate, endometrial, stomach, and esophageal neoplasms, and neoplasm metastasis. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does LY4257496 target?

LY4257496 is a small molecule, but its specific molecular target has not been disclosed in available information. The drug is being investigated in oncology for its potential anti-cancer activity across multiple tumor types, including breast, colorectal, prostate, and endometrial cancers.

Who makes LY4257496?

LY4257496 is being developed by Eli Lilly and Company, a pharmaceutical company publicly traded under the ticker symbol LLY on the New York Stock Exchange. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in cancer patients.

What phase is LY4257496 in?

LY4257496 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is actively recruiting participants to study the drug in patients with various types of cancer.

What clinical trials is LY4257496 in?

LY4257496 is being studied in a Phase 1 clinical trial with the identifier NCT07114601, titled "A Study of LY4257496 in Participants With Cancer (OMNIRAY)." This recruiting trial has an estimated enrollment of 421 participants and is being conducted in the United States, Canada, China, France, Germany, Japan, and Spain.

Is LY4257496 the same as OMNIRAY?

LY4257496 is the drug being studied in the clinical trial referred to as OMNIRAY. The trial title is "A Study of LY4257496 in Participants With Cancer (OMNIRAY)," indicating that OMNIRAY is the study name or program name for this investigational drug, not a separate drug entity.