Resumen

Elegibilidad

Detalles del diseño

Brazos e Intervenciones

Medidas de resultado

Sitios del ensayo

Fuente: NCT07114601

Reclutando

OMNIRAY: A Study of LY4257496 in Participants With Cancer (OMNIRAY)

Intervencionista

Fase 1

Barbara Ann Karmanos Cancer Institute

Patrocinador: Eli Lilly and Company

Última actualización: 17 de abril de 2026

Aviso: La información proviene de registros públicos y puede no reflejar cambios en tiempo real en el centro local.

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.

Categoría de tratamiento

Otros medicamentos, Prueba diagnóstica

Erforderliche Mutationen

Ensayo iniciado

6 de agosto de 2025

Última actualización por el patrocinador

17 de abril de 2026

Finalización estimada

1 de abril de 2030

Contacto del estudio

Nombre:Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Correo electrónico:LillyTrials@Lilly.com

Teléfono:1-317-615-4559

Nombre:Physicians interested in becoming principal investigators please contact

Correo electrónico:clinical_inquiry_hub@lilly.com

Elegibilidad

Criterios de inclusión

* 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

* Colorectal carcinoma

* Metastatic castration-resistant prostate cancer

* Endometrial carcinoma. Carcinosarcoma is eligible. Uterine leiomyosarcoma, adenosarcoma, or endometrial stromal sarcoma is not eligible.

* Other GRPR-positive solid tumor

* 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.

Criterios de exclusión

* Phase 1a (Cohort A1 and A2) only: Previously received radiopharmaceutical or radioligand therapy. For participants with metastatic castration-resistant prostate cancer (mCRPC), prior ¹⁷⁷Lu-prostate-specific membrane antigen (PSMA)-617 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) defined as positive for hepatitis B surface antigen (HBsAg) or Polymerase Chain Reaction (PCR) positive for HBV deoxyribonucleic acid (DNA) . 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) defined as positive for anti-HCV antibodies. 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.

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Detalles del diseño

AsignaciónNon-Randomized

Modelo de intervenciónParallel Assignment

EnmascaramientoNone (Open Label)

Número a inscribir421

Brazos e Intervenciones

Brazos

Intervenciones

Tipo: Experimental

Descripción: LY4257496 administered intravenously (IV)

Intervenciones:

LY4257496
Standard of Care Anticancer Therapies
LY4257529

Medidas de resultado

Medidas de resultado primarias

Phase 1a Dose Escalation: Maximum Tolerated Dose of LY4257496From Cycle 1 Day 1 (C1D1) through 28 days after the first dose of study drug. Cycle = 28 days

Phase 1a Dose Optimization: Number of Dose Limiting Toxicities of LY4257496From Cycle 1 Day 1 (C1D1) through 28 days after the first dose of study drug. Cycle = 28 days

Phase 1b Dose Expansion and Optimization: Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR)From C1D1 through efficacy follow-up, estimated as Week 42. Cycle = 42 weeks

Medidas de resultado secundarias

Phase 1a Dose Escalation and Optimization: ORR: Percentage of Participants with Best Response of CR or PRFrom C1D1 through efficacy follow-up, estimated as Week 42. Cycle = 42 weeks

Phase 1a Dose Escalation: Absorbed Dose Estimates (Gray (Gy)) of LY4257496 in Normal OrgansFrom C1D1 through 30 days after the last dose of study drug dose. Cycle = 30 days

Phase 1a Dose Escalation and Optimization: Absorbed Dose Estimates (Gy) of LY4257529 in Normal OrgansFrom end of injection at Screening, and at Day 30 through 1 day after injection

Phase 1a Dose Escalation Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY4257496From C1D1 through 30 days after the last dose of study drug dose. Cycle = 30 days

Phase 1a Dose Escalation and Optimization PK: Cmax of LY4257529From end of injection through 1 day after injection

Phase 1a Dose Escalation PK: Area Under the Curve (AUC) of LY4257496From C1D1 through 30 days after the last dose of study drug dose. Cycle = 30 days

Phase 1a Dose Escalation and Optimization PK: AUC of LY4257529From end of injection through 1 day after injection

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Sitios del ensayo

Este estudio tiene 28 sitios de ensayo

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, US

Reclutando

Detroit, Michigan, 48201 US

Barbara Ann Karmanos Cancer Institute

Aún no recluta

Boston, Massachusetts, 02215 US

Dana-Farber Cancer Institute

Aún no recluta

Boston, Massachusetts, 02114 US

Mass General Hospital

Aún no recluta

Duarte, California, 91010 US

City of Hope

Aún no recluta

Houston, Texas, 77030 US

MD Anderson Cancer Center

Aún no recluta

Paris, 75005 FR

Institut Curie

Reclutando

Stanford, California, 94305 US

Stanford University Medical Center

Aún no recluta

Kyoto, 606-8507 JP

Kyoto University Hospital

Aún no recluta

Chiba, 277-8577 JP

National Cancer Center Hospital East

Aún no recluta

Erlangen, 91054 DE

Universitaetsklinikum Erlangen

Reclutando

Santa Monica, California, 90404 US

University of California, Los Angeles (UCLA)

Aún no recluta

Barcelona, Barcelona, 8028 ES

Hospital Universitario Dexeus - Grupo Quirónsalud

Aún no recluta

Essen, 45147 DE

Universitaetsklinikum Essen

Aún no recluta

Toronto, M4N 3M5 CA

Sunnybrook Health Sciences Centre

Aún no recluta

New York, New York, 10016 US

New York University (NYU) Langone Medical Center

Reclutando

St Louis, Missouri, 63110 US

Washington University

Reclutando

Toronto, M5G 2M9 CA

Princess Margaret Hospital

Reclutando

New York, New York, 10065 US

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

Aún no recluta

Tampa, Florida, 33612 US

Moffitt

Aún no recluta

Hamilton, L8V 5C2 CA

Juravinski Cancer Centre

Reclutando

Miami, Florida, 33165 US

Biogenix Molecular, LLC

Aún no recluta

Saint-Herblain, 44805 FR

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

Reclutando

Grand Rapids, Michigan, 49503 US

BAMF Health Inc.

Aún no recluta

Montreal, H3T 1E2 CA

Lady Davis Institute for Medical Research Jewish General Hospital

Aún no recluta

München, 81675 DE

Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)

Aún no recluta

München, 80336 DE

LMU Klinikum Muenchen-Campus Grosshadern

Aún no recluta

Atlanta, Georgia, 30322 US

Emory University School of Medicine - Winship Cancer Institute

Aún no recluta

Dallas, Texas, 75246 US

Texas Oncology - DFW (Sammons CC)

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