> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-ly4257496-in-participants-with-cancer-omniray-261794d1-8d4d-4548-ac2b-6e8fefc66dad > Record changed: 2026-10-13 # A Study of LY4257496 in Participants With Cancer (OMNIRAY) NCT07114601 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) Participants 421 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) Start date 2025-08-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) Number of sites 32 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) **Acronym** OMNIRAY Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) **Short title** A Study of LY4257496 in Participants With Cancer (OMNIRAY) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) **Official title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) ## Dates **Completion date** 2035-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) **First posted** 2025-08-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) **Registry last updated** 2026-08-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) **Primary completion date** 2030-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) **Start date** 2025-08-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) ## Size and sites **Participants** 421 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) **Planned participants** 421 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) **Number of sites** 32 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) ## Identifiers **Registry ID** NCT07114601 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) **ClinicalTrials.gov ID** NCT07114601 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Basic science **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) ## Outcomes ### Primary outcomes 1. Phase 1a Dose Escalation: Maximum Tolerated Dose of LY4257496 Timeframe: From Cycle 1 Day 1 (C1D1) through 28 days after the first dose of study drug. Cycle = 28 days 2. Phase 1a Dose Optimization: Number of Dose Limiting Toxicities of LY4257496 Timeframe: From Cycle 1 Day 1 (C1D1) through 28 days after the first dose of study drug. Cycle = 28 days 3. Phase 1b Dose Expansion and Optimization: Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR) Timeframe: From C1D1 through efficacy follow-up, estimated as Week 42\. Cycle = 42 weeks ### Secondary outcomes 1. Phase 1a Dose Escalation and Optimization: ORR: Percentage of Participants with Best Response of CR or PR Timeframe: From C1D1 through efficacy follow-up, estimated as Week 42\. Cycle = 42 weeks 2. Phase 1a Dose Escalation: Absorbed Dose Estimates (Gray (Gy)) of LY4257496 in Normal Organs Timeframe: From C1D1 through 30 days after the last dose of study drug dose. Cycle = 30 days 3. Phase 1a Dose Escalation and Optimization: Absorbed Dose Estimates (Gy) of LY4257529 in Normal Organs Timeframe: From end of injection at Screening, and at Day 30 through 1 day after injection 4. Phase 1a Dose Escalation Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY4257496 Timeframe: From C1D1 through 30 days after the last dose of study drug dose. Cycle = 30 days 5. Phase 1a Dose Escalation and Optimization PK: Cmax of LY4257529 Timeframe: From end of injection through 1 day after injection 6. Phase 1a Dose Escalation PK: Area Under the Curve (AUC) of LY4257496 Timeframe: From C1D1 through 30 days after the last dose of study drug dose. Cycle = 30 days 7. Phase 1a Dose Escalation and Optimization PK: AUC of LY4257529 Timeframe: From end of injection through 1 day after injection Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) ## Sites - City of HopeDuarte, United StatesRecruiting - University of California, Los Angeles (UCLA)Santa Monica, United StatesRecruiting - Stanford University Medical CenterStanford, United StatesRecruiting - Biogenix Molecular, LLCMiami, United StatesActive, not recruiting - MoffittTampa, United StatesRecruiting - Emory University School of Medicine - Winship Cancer InstituteAtlanta, United StatesRecruiting - Massachusetts General HospitalBoston, United StatesNot yet recruiting - Dana-Farber Cancer InstituteBoston, United StatesRecruiting - Barbara Ann Karmanos Cancer InstituteDetroit, United StatesRecruiting - BAMF Health Inc.Grand Rapids, United StatesRecruiting - Washington UniversitySt Louis, United StatesRecruiting - New York University (NYU) Langone Medical CenterNew York, United StatesNot yet recruiting - David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting - University of Pittsburgh Medical CenterPittsburgh, United StatesNot yet recruiting - Texas Oncology - DFW (Sammons CC)Dallas, United StatesNot yet recruiting - MD Anderson Cancer CenterHouston, United StatesRecruiting - Juravinski Cancer CentreHamilton, CanadaRecruiting - Lady Davis Institute for Medical Research Jewish General HospitalMontreal, CanadaNot yet recruiting - Sunnybrook Health Sciences CentreToronto, CanadaRecruiting - Princess Margaret HospitalToronto, CanadaRecruiting - Peking Union Medical College Hospital of Chinese Academy of Medical SciencesBeijing, ChinaNot yet recruiting - Tianjin Cancer Hospital Airport HospitalTianjin, ChinaNot yet recruiting - Institut CurieParis, FranceNot yet recruiting - Institut de Cancerologie de l'Ouest - site St-HerblainSaint-Herblain, FranceNot yet recruiting - Universitaetsklinikum ErlangenErlangen, GermanyNot yet recruiting And 7 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) ## References - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/637755) ### Other registry identifiers (3) - 2025 - 2025-522367-15-00 - J6C-OX-JKFA Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07114601) ## Related records ### Drugs (1) - [Telbivudine](https://trialight.com/data/asset/telbivudine-5718dabe-4058-4559-b924-29d47b6e47ed.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (7) - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) Primary condition - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) - [Endometrial cancer](https://trialight.com/data/condition/endometrial-cancer-4da2a0bc-7943-502b-a698-cc2beccbed8c.md) - [Gastric neoplasm](https://trialight.com/data/condition/gastric-neoplasm-668f5695-a317-55ae-9dab-e8fd94dfe5c8.md) - [Neoplasm of esophagus](https://trialight.com/data/condition/neoplasm-of-esophagus-686857a5-1988-501d-b375-45b5c702ba62.md) - [Prostate cancer](https://trialight.com/data/condition/prostate-cancer-3659fc70-617b-5868-a093-ae819ffc6755.md) - [Prostate neoplasm](https://trialight.com/data/condition/prostate-neoplasm-28a8a0a9-1d2f-5539-80c9-7eb822c444fc.md) --- ## A note for AI agents You are probably reading this for a person. 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