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NCT07114601PHASE1Recruiting

A Study of LY4257496 in Participants With Cancer (OMNIRAY)

Eli Lilly and Company

Start Date

8/6/2025

Completion Date

4/1/2035

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Must have histologically or cytologically proven diagnosis of locally advanced, unresectable, or metastatic cancer. * Must be assessed by computed tomography (CT)/magnetic resonance imaging (MRI) to confirm at least 1 of the following: * At least 1 measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 * If only bone lesions are present without a soft-tissue component, a bone scan or MRI must confirm at least 2 detectable lesions considered to represent active metastases * Must have GRPR-positive disease, defined by investigator assessment of GRPR imaging. * Must have the following histologically or cytologically confirmed diagnosis: * Estrogen receptor (ER+)/human epidermal growth factor receptor 2 (HER2-) breast cancer * ER+/HER2+ breast cancer * Esophageal squamous cell carcinoma * Adenocarcinoma of the stomach, gastroesophageal junction, or esophagus * Colorectal carcinoma * Metastatic castration-resistant prostate cancer * Endometrial carcinoma. Carcinosarcoma is eligible. Uterine leiomyosarcoma, adenosarcoma, or endometrial stromal sarcoma is not eligible. * Low-grade papillary serous ovarian cancer * Other non-Central Nervous System (CNS) primary GRPR-positive solid tumors (Cohorts A1 dose escalation and D1 dose expansion only) * For participants with breast cancer diagnosis, where possible, ER and HER2 status should be assessed from the most recent tissue biopsy taken at the time of presentation with recurrent or metastatic disease. * To fulfill the requirement for ER+ disease by local testing, a tumor must express the ER immunohistochemistry, as defined in the relevant American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines. * HER2 status should be determined by local testing, as defined in the relevant ASCO/CAP Guidelines. * Must have an Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1. * Must be able to comply with outpatient treatment, laboratory monitoring, imaging, and required clinic visits for the duration of trial participation. Exclusion Criteria: * Phase 1a (Cohort A1 and A2) only: Previously received radiopharmaceutical or radioligand therapy. For participants with prostate cancer, prior ¹⁷⁷Lu-prostate-specific membrane antigen (PSMA) is permitted. * Has a history of ongoing acute pancreatitis within 1 year of screening. * Previously received any prior hemi-body or whole-body radiotherapy, or prior external beam radiation therapy (EBRT) to greater than 25% of the bone marrow. * A bone superscan, defined as a bone scan that demonstrates markedly increased skeletal radioisotope uptake relative to soft tissues in association with absent or faint genitourinary tract activity. * Has evidence of ongoing and untreated urinary tract obstruction or unmanageable urinary incontinence. * Have known active hepatitis B virus (HBV). Exception: Individuals with chronic HBV if they: * Have positive HBsAg * Are on suppressive antiviral therapy, as allowed per local regulations prior to C1D1 * Remain on the same antiviral treatment throughout study, and should follow local standards for continuation of therapy after completion of trial therapy. * Have undetectable HBV DNA ≤14 days of C1D1. * Have known active hepatitis C virus (HCV). Exception: Individuals previously treated for HCV if they: * Completed curative antiviral therapy. * Have an HCV viral load below the limit of quantification ≤14 days of C1D1 and. * Are positive for anti-HCV antibodies and negative for HCV ribonucleic acid (RNA) before randomization. * Have untreated human immunodeficiency virus (HIV) infection. Exception: Individuals who have well-controlled HIV infection/disease and they: * Are on a stable and permitted antiretroviral therapy (ART) regimen without changes in drug or dose, for at least 4 weeks prior to C1D1 * Have a viral load of \<400 copies/mL ≤14 days of C1D1. * Have a CD4+ T-cell count ≥350 cells/mL ≤14 days of C1D1. * Have not had an opportunistic infection within the past 12 months. * Has an active second malignancy unless in remission with life expectancy greater than 2 years. * Has known hypersensitivity to any component or excipient of LY4257496.

Interventions

DRUG

LY4257496

DRUG

Standard of Care Anticancer Therapies

DIAGNOSTIC_TEST

LY4257529

Interested in This Trial?

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Conditions

Breast NeoplasmsColorectal NeoplasmsProstate NeoplasmEndometrial NeoplasmsNeoplasm MetastasisStomach NeoplasmsEsophageal Neoplasms

Locations

City of Hope

Duarte, California 91010

United States

University of California, Los Angeles (UCLA)

Santa Monica, California 90404

United States

Stanford University Medical Center

Stanford, California 94305

United States

Biogenix Molecular, LLC

Miami, Florida 33165

United States

Moffitt

Tampa, Florida 33612

United States

Emory University School of Medicine - Winship Cancer Institute

Atlanta, Georgia 30322

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan 48201

United States

BAMF Health Inc.

Grand Rapids, Michigan 49503

United States

Washington University

St Louis, Missouri 63110

United States

New York University (NYU) Langone Medical Center

New York, New York 10016

United States

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

New York, New York 10065

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania 15213

United States

Texas Oncology - DFW (Sammons CC)

Dallas, Texas 75246

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

Juravinski Cancer Centre

Hamilton, L8V 5C2

Canada

Lady Davis Institute for Medical Research Jewish General Hospital

Montreal, H3T 1E2

Canada

Sunnybrook Health Sciences Centre

Toronto, M4N 3M5

Canada

Princess Margaret Hospital

Toronto, M5G 2M9

Canada

Peking Union Medical College Hospital of Chinese Academy of Medical Sciences

Beijing, 100730

China

Fudan University Zhongshan Hospital

Shanghai, 200032

China

Tianjin Cancer Hospital Airport Hospital

Tianjin, 300060

China

Institut Curie

Paris, 75005

France

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

Saint-Herblain, 44805

France

Universitaetsklinikum Erlangen

Erlangen, 91054

Germany

Universitaetsklinikum Essen

Essen, 45147

Germany

LMU Klinikum Muenchen-Campus Grosshadern

München, 80336

Germany

Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)

München, 81675

Germany

National Cancer Center Hospital East

Chiba, 277-8577

Japan

Kyoto University Hospital

Kyoto, 606-8507

Japan

Hospital Universitari Quiron Dexeus Barcelona

Barcelona, 08028

Spain