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A Study of LY4257496 in Participants With Cancer (OMNIRAY)

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NCT07114601 · readout ≤ 1,349 d

Sponsored by Eli Lilly and Company (industry) · LLY — their whole pipeline →.

Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Basic science
Enrollment
421estimated
Sites
32
Countries
Canada, China, France +4

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2025-08-06actualWhen the study began enrolling
Primary completionApr 2030estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completionApr 2035estimatedThe whole study's end, after follow-up
First posted2025-08-11actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-08-06actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

  • Breast Neoplasms
  • Colorectal Neoplasms
  • Prostate Neoplasm
  • Endometrial Neoplasms
  • Neoplasm Metastasis
  • Stomach Neoplasms
  • Esophageal Neoplasms

Interventions

  • Drug: LY4257496
  • Drug: Standard of Care Anticancer Therapies
  • Diagnostic test: LY4257529

Primary outcomes

what the primary-completion date above is the date OF
Phase 1a Dose Escalation: Maximum Tolerated Dose of LY4257496
measured 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
measured 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)
measured From C1D1 through efficacy follow-up, estimated as Week 42. Cycle = 42 weeks

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