drugset / Trial / NCT07114601

A Study of LY4257496 in Participants With Cancer (OMNIRAY)

NCT07114601

Phase 1 Recruiting 421 enrolled Eli Lilly and Company
Non-randomizedParallel-groupOpen-labelBasic science

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 cancer, including but not limited to breast, colorectal, prostate, endometrial, esophageal, gastroesophageal (GE) junction, and gastric 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.

Timeline

Start
2025-08-06
Primary completion
2030-04
Completion
2035-04

Drugs

EvaluationDrugModalityDoseRoute
Subject LY4257496 Other / unclassified Intravenous
Background Abemaciclib Small molecule
Background Capecitabine Small molecule
Background Fulvestrant Small molecule
Background Imlunestrant Small molecule