A Study of LY4257496 in Participants With Cancer (OMNIRAY)
18 Years and older, Male and Female
27354 (primary)
NCI-2025-06835
2025-522367-15-00
J6C-OX-JKFA
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 cancer,
including but not limited to breast, colorectal, prostate, endometrial, esophageal,
gastroesophageal (GE) junction, and gastric 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.
Eligibility
- 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.
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
Click here to learn more about clinical trials.