A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Condition(s) studied
Investigational drug(s) / intervention(s)
LY4257496: Administered IV
Standard of Care Anticancer Therapies: Fulvestrant, Imlunestrant, Aromatase Inhibitors, Capecitabine, Abemaciclib
LY4257529: Administered IV at select sites
Study 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
Primary outcome measure(s)
- Phase 1a Dose Escalation: Maximum Tolerated Dose of LY4257496 — From 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 LY4257496 — From 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
Trial sites (33)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope | Duarte | California | Recruiting |
| University of California, Los Angeles (UCLA) | Santa Monica | California | Recruiting |
| Stanford University Medical Center | Stanford | California | Recruiting |
| Biogenix Molecular, LLC | Miami | Florida | Active Not Recruiting |
| Moffitt | Tampa | Florida | Recruiting |
| Emory University School of Medicine - Winship Cancer Institute | Atlanta | Georgia | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Not Yet Recruiting |
| Dana-Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | Recruiting |
| BAMF Health Inc. | Grand Rapids | Michigan | Recruiting |
| Washington University | St Louis | Missouri | Recruiting |
| New York University (NYU) Langone Medical Center | New York | New York | Not Yet Recruiting |
| David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | Not Yet Recruiting |
| Texas Oncology - DFW (Sammons CC) | Dallas | Texas | Not Yet Recruiting |
| MD Anderson Cancer Center | Houston | Texas | Recruiting |
| Juravinski Cancer Centre | Hamilton | Canada | Recruiting |
| Lady Davis Institute for Medical Research Jewish General Hospital | Montreal | Canada | Not Yet Recruiting |
| Sunnybrook Health Sciences Centre | Toronto | Canada | Recruiting |
| Princess Margaret Hospital | Toronto | Canada | Recruiting |
| Peking Union Medical College Hospital of Chinese Academy of Medical Sciences | Beijing | China | Not Yet Recruiting |
| Tianjin Cancer Hospital Airport Hospital | Tianjin | China | Not Yet Recruiting |
| Institut Curie | Paris | France | Not Yet Recruiting |
| Institut de Cancerologie de l'Ouest - site St-Herblain | Saint-Herblain | France | Not Yet Recruiting |
| Universitaetsklinikum Erlangen | Erlangen | Germany | Not Yet Recruiting |
| Universitaetsklinikum Essen | Essen | Germany | Recruiting |
| LMU Klinikum Muenchen-Campus Grosshadern | München | Germany | Not Yet Recruiting |
| Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) | München | Germany | Not Yet Recruiting |
| National Cancer Center Hospital East | Chiba | Japan | Not Yet Recruiting |
| Kyoto University Hospital | Kyoto | Japan | Not Yet Recruiting |
| The University of Osaka Hospital | Osaka | Japan | Not Yet Recruiting |
| Hospital Universitari Quiron Dexeus Barcelona | Barcelona | Spain | Not Yet Recruiting |
| South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz | Madrid | Spain | Not Yet Recruiting |
More Eli Lilly and Company trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07114601 on ClinicalTrials.gov ↗ ← All trials in the USA