A Phase 1a/b Multicenter, Open-Label Trial to Evaluate Safety, Tolerability, and Dosimetry of LY4257496, a GRPR-Targeted Radioligand Therapy, in Adults With GRPR-Positive Advanced Solid Tumors (OMNIRAY)
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 breast, colorectal, prostate, and endometrial cancer. This is a 2-part study. Participation could last up to 36 weeks or until your tumor progresses.
• 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
⁃ Colorectal carcinoma
⁃ Metastatic castration-resistant prostate cancer
⁃ Endometrial carcinoma
⁃ Other GRPR-positive solid tumor
• 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.