A Study of LY4257496 in Participants With Cancer (OMNIRAY) (NCT07114601) | Clinical Trial Compass
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
United States, Canada, China421 participantsStarted 2025-08-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 presen…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase 1a Dose Escalation: Maximum Tolerated Dose of LY4257496
Timeframe: From Cycle 1 Day 1 (C1D1) through 28 days after the first dose of study drug. Cycle = 28 days
2
Phase 1a Dose Optimization: Number of Dose Limiting Toxicities of LY4257496
Timeframe: From Cycle 1 Day 1 (C1D1) through 28 days after the first dose of study drug. Cycle = 28 days
3
Phase 1b Dose Expansion and Optimization: Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR)
Timeframe: From C1D1 through efficacy follow-up, estimated as Week 42. Cycle = 42 weeks
Trial details
NCT IDNCT07114601
SponsorEli Lilly and Company
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2030-04
Contact for this trial
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or