Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07114601 · ClinicalTrials.gov registry record · Phase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
A Phase 1 study of Breast Neoplasms and Colorectal Neoplasms, sponsored by Eli Lilly and Company.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 421
- Enrollment target
- 20
- Study locations
NCT07114601: Recruiting Phase 1 study of Breast Neoplasms and Colorectal Neoplasms, sponsored by Eli Lilly and Company.
NCT07114601 is a Phase 1 study of Breast Neoplasms and Colorectal Neoplasms that is actively recruiting participants, run by Eli Lilly and Company. The registered enrollment target is 421 participants, below the 565-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (25% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07114601, a Phase 1 study of Breast Neoplasms and Colorectal Neoplasms, is actively recruiting participants, sponsored by Eli Lilly and Company.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 421 participants
- Enrollment target
- 20
- Study locations
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 |
What NCT07114601 shows while recruiting
NCT07114601 is an interventional study that assigns participants to a tested intervention. The registered 421 participants enrollment target is mid-sized for trials with a published cap, below the 565-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (25% lower).
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.
NCT07114601 names 20 study sites across 9 states, led by Other, California, Florida.
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.
What interventions are being tested in trial NCT07114601?
The interventions under investigation include: LY4257496 (DRUG), Standard of Care Anticancer Therapies (DRUG), LY4257529 (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT07114601?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Breast Neoplasms
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07114601's enrollment target sits among peer trials
421 26th of 97 higher than 72 of 97 other Breast Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Focused Ultrasound and Gemcitabine in Breast Cancer
RECRUITING · Phase 1
-
A Study of LY4337713 in Participants With FAP-Positive Solid Tumors
RECRUITING · Phase 1
-
Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer
RECRUITING · Phase 1
-
Safety/Efficacy Study of CID-078 in Patients With Advanced Solid Tumor Malignancies
RECRUITING · Phase 1
-
A Study of DM001 in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
A Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05976763 · 421 participants · Phase 3
Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma
- NCT04763356 · 422 participants · NA
Remote Monitoring and Management of Chemotherapy Induced Peripheral Neuropathy
- NCT06837246 · 422 participants · NA
A Clinical Trial to Assess Cognitive Effects of Cognitive Nutritional Supplement in General Population
- NCT07298967 · 422 participants · NA
ORCHARDS-AIR Study
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI