Actively Recruiting
A Phase 1a/b Open-Label Trial Evaluating LY4257496, a GRPR-Targeted Radioligand Therapy, in Adults With GRPR-Positive Advanced Solid Tumors
Led by Eli Lilly and Company · Updated on 2026-06-03
421
Participants Needed
30
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of LY4257496, a radioligand therapy targeting the Gastrin-releasing Peptide Receptor (GRPR), in adults with advanced GRPR-positive cancers such as breast, colorectal, prostate, endometrial, esophageal, gastroesophageal junction, and gastric cancers. This phase 1a/b, open-label study also assesses LY4257529, a diagnostic agent used to identify cancers with high GRPR levels. The study aims to determine appropriate dosing and response rates in this patient population. The study consists of two parts with various cohorts receiving LY4257496 intravenously, either alone or combined with standard anticancer therapies like Fulvestrant, Imlunestrant, Aromatase Inhibitors, Capecitabine, or Abemaciclib. LY4257529 is administered intravenously at selected sites for diagnostic purposes. Participants may receive dose escalation, dose optimization, or combination treatment depending on their specific cancer type and cohort assignment. Participants will undergo regular assessments including imaging scans such as CT or MRI to measure tumor response, laboratory monitoring, and safety evaluations throughout the study duration, which could last up to 36 weeks or until tumor progression. Researchers will monitor dose-limiting toxicities, maximum tolerated dose, drug concentration levels, and objective response rates. Follow-up will continue to evaluate treatment effects and safety after dosing periods.
CONDITIONS
Brief Title
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must have a confirmed diagnosis of locally advanced, unresectable, or metastatic cancer
- Must have at least one measurable tumor lesion or multiple bone lesions confirmed by imaging
- Must have GRPR-positive disease confirmed by imaging
- Must have one of the specified cancer types including breast (ER+/HER2- or HER2+), esophageal, stomach, colorectal, prostate, endometrial (excluding certain sarcomas), low-grade papillary serous ovarian cancer, or other non-CNS GRPR-positive solid tumors
- Breast cancer participants must have ER and HER2 status assessed from recent biopsy when possible
- Must have an ECOG performance status of 0 or 1
- Must be able to comply with outpatient treatment, laboratory monitoring, imaging, and clinic visits for the study duration
You will not qualify if you...
- Participants in phase 1a cohorts must not have received prior radiopharmaceutical or radioligand therapies (except certain prostate cancer treatments)
- History of acute pancreatitis within the past year
- Prior hemi-body or whole-body radiotherapy or external beam radiation to over 25% of bone marrow
- Bone superscan on bone scan indicating extensive skeletal uptake
- Untreated urinary tract obstruction or uncontrolled urinary incontinence
- Active hepatitis B or C infections unless well-controlled and treated
- Untreated HIV infection unless well-controlled under stable treatment
- Active second malignancy unless in remission with life expectancy over 2 years
- Known hypersensitivity to LY4257496 or its components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for imaging and laboratory tests
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive LY4257496 intravenously, alone or with standard anticancer therapies, to evaluate safety and response.
Regular visits for dosing and monitoring during each 28-day cycle
Duration - Up to 42 weeks from first dose
Participants are monitored for treatment response and safety after completion of treatment.
Periodic visits for imaging and safety assessments
Trial Site Locations
Total: 30 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
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
15
Texas Oncology - DFW (Sammons CC)
Dallas, Texas, United States, 75246
Not Yet Recruiting
16
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
17
Juravinski Cancer Centre
Hamilton, Canada, L8V 5C2
Not Yet Recruiting
18
Lady Davis Institute for Medical Research Jewish General Hospital
Montreal, Canada, H3T 1E2
Not Yet Recruiting
19
Sunnybrook Health Sciences Centre
Toronto, Canada, M4N 3M5
Actively Recruiting
20
Princess Margaret Hospital
Toronto, Canada, M5G 2M9
Actively Recruiting
21
Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
Beijing, China, 100730
Not Yet Recruiting
22
Institut Curie
Paris, France, 75005
Not Yet Recruiting
23
Institut de Cancerologie de l'Ouest - site St-Herblain
Saint-Herblain, France, 44805
Not Yet Recruiting
24
Universitaetsklinikum Erlangen
Erlangen, Germany, 91054
Not Yet Recruiting
25
Universitaetsklinikum Essen
Essen, Germany, 45147
Not Yet Recruiting
26
LMU Klinikum Muenchen-Campus Grosshadern
München, Germany, 80336
Not Yet Recruiting
27
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
München, Germany, 81675
Not Yet Recruiting
28
National Cancer Center Hospital East
Chiba, Japan, 277-8577
Not Yet Recruiting
29
Kyoto University Hospital
Kyoto, Japan, 606-8507
Not Yet Recruiting
30
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
P
Physicians interested in becoming principal investigators please contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
5
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here