Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
The main purpose of this study is to evaluate safety, tolerability, and how well it works of LY4257496 alone and as part of relevant standard of care (SOC) combination therapy in participants with Gastrin-releasing Peptide Receptor (GRPR)-positive advanced cancer, including but not limited to breast, colorectal, prostate, endometrial, esophageal, gastroesophageal (GE) junction, and gastric cancer. The study will also measure the safety, tolerability, and how well it works of LY4257529 to identify cancer with high levels of a protein called GRPR.
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are LY4257496, Standard of Care Anticancer Therapies, or LY4257529. The registry lists allocation as randomized. The main purpose of this study is to evaluate safety, tolerability, and how well it works of LY4257496 alone and as part of relevant standard of care (SOC) combination therapy in participants with Gastrin-releasing Peptide Receptor (GRPR)-positive advanced cancer, including but not limited to breast, colorectal, prostate, endometrial, esophageal, gastroesophageal (GE) junction, and gastric cancer.
They plan to enroll about 421 people at 33 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Phase 1a/b Multicenter, Open-Label Trial to Evaluate Safety, Tolerability, and Dosimetry of LY4257496, a GRPR-Targeted Radioligand Therapy, in Adults With GRPR-Positive Advanced Solid Tumors (OMNIRAY)
Interventions: LY4257496, Standard of Care Anticancer Therapies, LY4257529
Primary outcome (registry wording): Phase 1a Dose Escalation: Maximum Tolerated Dose of LY4257496
Who it is for (from inclusion criteria)
Ages 18 Years to any
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
Who the registry excludes
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
Public study contact (from the registry)
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
We will investigate the clinical manifestations and molecular genetic defects of heritable urologic malignant disorders. Families with urologic malignancy with known or suspected genetic basis will be enrolled.
This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their relatives to learn more about how the disease develops and changes over time. It will also study genetic factors that make a person susceptible to SLE.
This study is designed to explore the genetics and pathophysiology of diseases presenting with intermittent fever, including familial Mediterranean fever, TRAPS, hyper-IgD syndrome, and related diseases. The following individuals may be eligible for this natural history study: 1) patients with known or suspected familial Mediterranean fever, TRAPS, hyper-IgD syndrome or related disorders; 2) relatives of these patients; 3) healthy, normal volunteers 7 years of age or older.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07114601?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07114601?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.