LY4257496 / Eli Lilly - LARVOL DELTA

A phase 1 study of LY4257496, a novel GRPR-targeted radioligand therapy, in patients with GRPR-positive metastatic ER+ breast cancer and other advanced solid tumors - OMNIRAY (Trial in Progress) (SABCS 2025) - "Dose expansion will enroll pts with ER+, HER2- MBC treated with LY4257496 monotherapy (cohort B1) and in combination with ET (cohort B2), capecitabine (cohort B3), or ET + abemaciclib (cohort B4)...Key exclusions include prior radiopharmaceutical (except 177Lu-PSMA-617 for mCRPC), recent pancreatitis, and untreated central nervous system metastases.Key study objectives: Evaluate safety, antitumor activity, optimal dose, PK, and biodistribution and dosimetry of LY4257496. Table ETa, fulvestrant or imlunestrant; ETb, investigators' choice of aromatase inhibitor, fulvestrant, or imlunestrant1Stoykow C, et al. Theranostics 2016, 6:1641-50"

Clinical • Metastases • P1 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • GRP-10 • HER-2

A Study of LY4257496 in Participants With Cancer (OMNIRAY) (clinicaltrials.gov) - P1 | N=421 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P1 trial • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of LY4257496 in Participants With Cancer (OMNIRAY) (clinicaltrials.gov) - P1 | N=421 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Oncology • Prostate Cancer • Solid Tumor