A Study of LY4257496 in Participants With Cancer (OMNIRAY)
This study, called OMNIRAY, is testing a new treatment called LY4257496 for people with advanced cancers such as breast, colorectal, prostate, and endometrial cancers that have spread. It also evaluates LY4257529, a diagnostic test to find cancers with high levels of a protein called GRPR. The study aims to see how safe and effective LY4257496 is, both alone and when combined with standard cancer treatments like Fulvestrant or Capecitabine. To join, you must have advanced cancer that has been confirmed by a doctor and have at least one measurable tumor. The study will measure how many participants respond to the treatment, and how safe the treatment is. The current status of this study is unclear.
- Study design
- This is a two-part interventional study planning to enroll 421 participants. It will evaluate the safety and effectiveness of LY4257496.
- What's involved
- Participation could last up to 36 weeks or until your tumor progresses. You will receive LY4257496 intravenously (IV) and potentially other standard anticancer therapies.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure responses to treatment from the first day of treatment through efficacy follow-up, estimated as Week 42.
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NCT07114601
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Recruiting
PHASE1Ages 18+InterventionalBasic scienceEli Lilly and Company
~421 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:LY4257496Standard of Care Anticancer TherapiesLY4257529
At a glance
Recruiting sites
15 of 32 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1a Dose Escalation: Maximum Tolerated Dose of LY4257496
Measured over From Cycle 1 Day 1 (C1D1) through 28 days after the first dose of study drug. Cycle = 28 days
+2 more outcomes measured
Conditions
Where it's being run
32 sites across 15 statesCanada4
Germany4
California3
Florida2
Massachusetts2
Michigan2
New York2
Texas2
Study leadership
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company
Who to contact
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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.
What this trial measures
- Phase 1a Dose Escalation: Maximum Tolerated Dose of LY4257496From Cycle 1 Day 1 (C1D1) through 28 days after the first dose of study drug. Cycle = 28 days
- Phase 1a Dose Optimization: Number of Dose Limiting Toxicities of LY4257496From Cycle 1 Day 1 (C1D1) through 28 days after the first dose of study drug. Cycle = 28 days
- Phase 1b Dose Expansion and Optimization: Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR)From C1D1 through efficacy follow-up, estimated as Week 42. Cycle = 42 weeks