Study of 89Zr-DFO-REGN5054 Imaging and Cemiplimab Treatment in Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are studying an experimental imaging drug called 89Zr-DFO-REGN5054 along with cemiplimab in patients with advanced or metastatic solid tumors. The study aims to understand the safety and tolerability of the imaging drug and how it behaves in the body, especially how the immune system interacts with tumors treated with cemiplimab. This is a Phase 1 clinical trial led by Regeneron Pharmaceuticals focusing on patients whose tumors may show important immune features through imaging. Participants receive 89Zr-DFO-REGN5054 via intravenous infusion in two parts Part A involves dose adjustments based on assessments, and Part B uses a defined dose determined from Part A. Cemiplimab is given by intravenous infusion every three weeks. The study combines these treatments to evaluate the imaging agents distribution and safety alongside standard cemiplimab therapy. During the study, participants undergo PET imaging on days 1, 5, and 8 to assess how the imaging drug is taken up by tumors and normal tissues. Blood samples are collected to measure drug levels and immune response. Researchers monitor side effects up to week 115 and evaluate treatment-emergent adverse events shortly after infusion. Tumor biopsies and other assessments help understand the imaging signals and immune markers. Participants are followed closely throughout to assess safety and drug behavior.

A Study of ImmunoPet Imaging Using 89Zr-DFO-REGN5054 in Adult Participants With Solid Cancers Treated With Cemiplimab