MedTrace Logo

A Study of LY4257496 in Participants With Cancer (OMNIRAY)

NCT07114601 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 421

Last updated 2026-05-22

No results posted yet for this study

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

DRUG

LY4257496

Administered IV

DRUG

Standard of Care Anticancer Therapies

Fulvestrant, Imlunestrant, Aromatase Inhibitors, Capecitabine, Abemaciclib

DIAGNOSTIC_TEST

LY4257529

Administered IV at select sites

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-06
Primary Completion
2030-04-30
Completion
2035-04-30
FDA Drug
Yes

Countries

  • United States
  • Canada
  • China
  • France
  • Germany
  • Japan
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07114601 on ClinicalTrials.gov