Actively Recruiting
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Led by Eli Lilly and Company · Updated on 2026-05-14
421
Participants Needed
28
Research Sites
503 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locally advanced, unresectable, or metastatic cancer
- At least one measurable target lesion by CT or MRI, or at least two active bone metastases if only bone lesions present
- GRPR-positive disease confirmed by imaging
- Diagnosed with ER+/HER2- or ER+/HER2+ breast cancer, colorectal carcinoma, metastatic castration-resistant prostate cancer, endometrial carcinoma (excluding certain sarcomas), or other GRPR-positive solid tumors
- For breast cancer, ER and HER2 status assessed from recent biopsy per ASCO/CAP guidelines
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Able to comply with outpatient treatment, lab tests, imaging, and clinic visits for study duration
You will not qualify if you...
- Previously received radiopharmaceutical or radioligand therapy (except for 177Lu-PSMA-617 in mCRPC participants in Phase 1a)
- History of ongoing acute pancreatitis within 1 year prior to screening
- Prior hemi-body or whole-body radiotherapy, or external beam radiation therapy covering more than 25% of bone marrow
- Bone superscan showing markedly increased skeletal uptake with absent or faint genitourinary activity
- Ongoing untreated urinary tract obstruction or unmanageable urinary incontinence
- Active hepatitis B infection unless on suppressive antiviral therapy with undetectable viral load
- Active hepatitis C infection unless previously treated with curative therapy and undetectable viral load
- Untreated HIV infection unless well controlled with stable antiretroviral therapy and no recent opportunistic infections
- Active second malignancy unless in remission with life expectancy over 2 years
- Known hypersensitivity to any component of LY4257496
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 28 locations
1
City of Hope
Duarte, California, United States, 91010
Not Yet Recruiting
2
University of California, Los Angeles (UCLA)
Santa Monica, California, United States, 90404
Actively Recruiting
3
Stanford University Medical Center
Stanford, California, United States, 94305
Actively Recruiting
4
Biogenix Molecular, LLC
Miami, Florida, United States, 33165
Actively Recruiting
5
Moffitt
Tampa, Florida, United States, 33612
Not Yet Recruiting
6
Emory University School of Medicine - Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
7
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
8
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
9
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
10
BAMF Health Inc.
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
11
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
12
New York University (NYU) Langone Medical Center
New York, New York, United States, 10016
Not Yet Recruiting
13
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
14
Texas Oncology - DFW (Sammons CC)
Dallas, Texas, United States, 75246
Not Yet Recruiting
15
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
16
Juravinski Cancer Centre
Hamilton, Canada, L8V 5C2
Not Yet Recruiting
17
Lady Davis Institute for Medical Research Jewish General Hospital
Montreal, Canada, H3T 1E2
Not Yet Recruiting
18
Sunnybrook Health Sciences Centre
Toronto, Canada, M4N 3M5
Not Yet Recruiting
19
Princess Margaret Hospital
Toronto, Canada, M5G 2M9
Actively Recruiting
20
Institut Curie
Paris, France, 75005
Not Yet Recruiting
21
Institut de Cancerologie de l'Ouest - site St-Herblain
Saint-Herblain, France, 44805
Not Yet Recruiting
22
Universitaetsklinikum Erlangen
Erlangen, Germany, 91054
Not Yet Recruiting
23
Universitaetsklinikum Essen
Essen, Germany, 45147
Not Yet Recruiting
24
LMU Klinikum Muenchen-Campus Grosshadern
München, Germany, 80336
Not Yet Recruiting
25
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
München, Germany, 81675
Not Yet Recruiting
26
National Cancer Center Hospital East
Chiba, Japan, 277-8577
Not Yet Recruiting
27
Kyoto University Hospital
Kyoto, Japan, 606-8507
Not Yet Recruiting
28
Hospital Universitari Quiron Dexeus Barcelona
Barcelona, Spain, 08028
Not Yet Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
P
Physicians interested in becoming principal investigators please contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
5
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