RecruitingPhase 1NCT07114601

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)

Sponsor

Eli Lilly and Company

Enrollment

421 participants

Start Date

Aug 6, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Neoplasms Colorectal Neoplasms Prostate Neoplasm Neoplasm Metastasis Endometrial Neoplasms

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests an experimental drug called LY4257496, which is a targeted radiation therapy that homes in on a protein called GRPR found on certain cancer cells. It is being studied in people with several types of advanced cancers that have spread and can no longer be surgically removed. **You may be eligible if...** - You have advanced or metastatic cancer confirmed by tissue biopsy - Your cancer tests positive for the GRPR protein on imaging - Eligible cancer types include: certain breast cancers (ER+), colorectal cancer, metastatic prostate cancer, endometrial cancer, or other GRPR-positive solid tumors - You have at least one measurable tumor on imaging **You may NOT be eligible if...** - Your cancer does not express the GRPR protein - You have uncontrolled serious medical conditions - You have had a prior organ or stem cell transplant - You have active autoimmune disorders requiring treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLY4257496

Administered IV

DRUGStandard of Care Anticancer Therapies

Fulvestrant, Imlunestrant, Aromatase Inhibitors, Capecitabine, Abemaciclib

DIAGNOSTIC_TESTLY4257529

Administered IV at select sites

Locations(28)

City of Hope

Duarte, California, United States

University of California, Los Angeles (UCLA)

Santa Monica, California, United States

Stanford University Medical Center

Stanford, California, United States

Biogenix Molecular, LLC

Miami, Florida, United States

Moffitt

Tampa, Florida, United States

Emory University School of Medicine - Winship Cancer Institute

Atlanta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

BAMF Health Inc.

Grand Rapids, Michigan, United States

Washington University

St Louis, Missouri, United States

New York University (NYU) Langone Medical Center

New York, New York, United States

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

New York, New York, United States

Texas Oncology - DFW (Sammons CC)

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Juravinski Cancer Centre

Hamilton, Canada

Lady Davis Institute for Medical Research Jewish General Hospital

Montreal, Canada

Sunnybrook Health Sciences Centre

Toronto, Canada

Princess Margaret Hospital

Toronto, Canada

Institut Curie

Paris, France

Institut de Cancerologie de l'Ouest - site St-Herblain

Saint-Herblain, France

Universitaetsklinikum Erlangen

Erlangen, Germany

Universitaetsklinikum Essen

Essen, Germany

LMU Klinikum Muenchen-Campus Grosshadern

München, Germany

Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)

München, Germany

National Cancer Center Hospital East

Chiba, Japan

Kyoto University Hospital

Kyoto, Japan

Hospital Universitari Quiron Dexeus Barcelona

Barcelona, Spain

View Full Details on ClinicalTrials.gov

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