A Study of a New Targeted Radioligand Therapy (LY4257496) in Patients with Advanced Solid Tumors Expressing GRPR

Advanced-stage cancers can spread to other organs and are often incurable at that point. A specific protein, known as the gastrin-releasing peptide receptor (GRPR), is found on the surface of many cancer cells. This protein is particularly common in various types of tumors, including breast cancer, colorectal cancer, prostate cancer, and endometrial cancer. LY4257496 is a novel radioligand therapy that specifically binds to the GRPR on the surface of cancer cells and releases radioactive radiation there, which is intended to damage the cancer cells from the inside out. The drug is administered as an intravenous infusion and is still undergoing clinical trials. Before therapy begins, an imaging procedure is used to verify whether the tumor cells actually express GRPR on their surface, since the radioligand therapy specifically binds to this marker. The diagnostic agent LY4257529 is used for this purpose at selected study sites.

The goal of this Phase 1a/b study is to investigate the safety, tolerability, and efficacy of the new radioligand therapy LY4257496 in patients with advanced solid tumors. The OMNIRAY study is an open-label (unblinded) Phase 1 study divided into two parts. This means that both the study physicians and the patients know which drug is being administered. In the first part (Phase 1a), cohorts receiving increasing doses will be used to determine the safe dose of the drug and how it is distributed in the body. In the second part (Phase 1b), LY4257496 will be further investigated in tumor-specific cohorts, either alone or in combination with standard therapies. The study is not randomized. All patients will receive the study drug. Participation lasts up to approximately 36 weeks or until the disease progresses.

Women and men aged 18 and older with advanced, inoperable, or metastatic GRPR-positive solid tumors who are in sufficient general health may participate in this study.