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A Study of LY4257496 in Participants With Cancer (OMNIRAY)
NCT07114601 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 421 participants |
| Start Date | 2025-08-06 |
| Est. Completion | 2035-04 |
| Phase | Phase 1 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 421 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 704 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07114601 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07114601?
The interventions under investigation include: LY4257496 (DRUG), Standard of Care Anticancer Therapies (DRUG), LY4257529 (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07114601?
This trial is sponsored by Eli Lilly and Company, which has 704 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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