NCT07114601

A Study of LY4257496 in Participants With Cancer (OMNIRAY)

A Phase 1a/b Multicenter, Open-Label Trial to Evaluate Safety, Tolerability, and Dosimetry of LY4257496, a GRPR-Targeted Radioligand Therapy, in Adults With GRPR-Positive Advanced Solid Tumors (OMNIRAY)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 421 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate safety, tolerability, and efficacy of LY4257496 alone and as part of relevant standard of care (SOC) combination therapy in participants with Gastrin-releasing Peptide Receptor (GRPR)-positive advanced breast, colorectal, prostate, and endometrial cancer. The study will also evaluate the safety, tolerability, and efficacy of LY4257529 to identify cancer with high levels of a protein called GRPR. This is a 2-part study. Participation could last up to 36 weeks or until your tumor progresses.

Conditions

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

Interventions

Type	Name	Description
DRUG	LY4257496	Administered IV
DRUG	Standard of Care Anticancer Therapies	Fulvestrant, Imlunestrant, Aromatase Inhibitors, Capecitabine, Abemaciclib
DIAGNOSTIC_TEST	LY4257529	Administered IV at select sites

Timeline

• Start date: 2025-08-06
• Primary completion: 2030-04-01
• Completion: 2035-04-01
• First posted: 2025-08-11
• Last updated: 2026-04-17

Locations

28 sites across 6 countries: United States, Canada, France, Germany, Japan, Spain

Regulatory

• FDA-regulated drug study