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NCT07114601 · ClinicalTrials.gov registry record · Phase 1

A Study of LY4257496 in Participants With Cancer (OMNIRAY)

A Phase 1 study of Breast Neoplasms and Colorectal Neoplasms, sponsored by Eli Lilly and Company.

Recruiting
Registry status
Phase 1
Development phase
421
Enrollment target
20
Study locations

NCT07114601 is a Phase 1 study of Breast Neoplasms and Colorectal Neoplasms that is actively recruiting participants, run by Eli Lilly and Company. The registered enrollment target is 421 participants, below the 565-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (25% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT07114601, a Phase 1 study of Breast Neoplasms and Colorectal Neoplasms, is actively recruiting participants, sponsored by Eli Lilly and Company.

RECRUITING
Registry status
Phase 1
Development phase
421 participants
Enrollment target
20
Study locations

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 Studied

Breast Neoplasms Colorectal Neoplasms Neoplasm Metastasis Endometrial Neoplasms Prostate Neoplasm

Interventions

  • DRUG LY4257496
  • DRUG Standard of Care Anticancer Therapies
  • DIAGNOSTIC_TEST LY4257529

Study Locations (20)

Other

  • Juravinski Cancer Centre - Hamilton
  • Lady Davis Institute for Medical Research Jewish General Hospital - Montreal
  • Sunnybrook Health Sciences Centre - Toronto
  • Princess Margaret Hospital - Toronto
  • Institut Curie - Paris
  • Institut de Cancerologie de l'Ouest - site St-Herblain - Saint-Herblain
  • Universitaetsklinikum Erlangen - Erlangen

California

  • City of Hope - Duarte
  • University of California, Los Angeles (UCLA) - Los Angeles
  • Stanford University Medical Center - Stanford

Florida

  • Biogenix Molecular, LLC - Miami
  • Moffitt - Tampa

Michigan

  • Barbara Ann Karmanos Cancer Institute - Detroit
  • BAMF Health Inc. - Grand Rapids

Texas

  • Texas Oncology - DFW (Sammons CC) - Dallas
  • MD Anderson Cancer Center - Houston

Georgia

  • Emory University School of Medicine - Winship Cancer Institute - Atlanta

Massachusetts

  • Massachusetts General Hospital - Boston

Missouri

  • Washington University - St Louis

Trial Details

FieldValue
Enrollment Target 421 participants
Start Date 2025-08-06
Est. Completion 2035-04
Phase Phase 1

Sponsor

Eli Lilly and Company

1,341 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07114601

The ClinicalTrials.gov registry entry for NCT07114601 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 421 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 565-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (25% lower). The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Breast Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which LY4257496 is the first listed.

NCT07114601 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, California, Florida.

Frequently Asked Questions

What is clinical trial NCT07114601 about?

NCT07114601 is a clinical study titled "A Study of LY4257496 in Participants With Cancer (OMNIRAY)". 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...

What is the current status of trial NCT07114601?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 421 participants. The study started on 2025-08-06. Estimated completion is 2035-04.

What conditions does trial NCT07114601 study?

This clinical trial studies the following conditions: Breast Neoplasms, Colorectal Neoplasms, Neoplasm Metastasis, Endometrial Neoplasms, Prostate Neoplasm.

What interventions are being tested in trial NCT07114601?

The interventions under investigation include: LY4257496 (DRUG), Standard of Care Anticancer Therapies (DRUG), LY4257529 (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT07114601?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07114601 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.