Early Phase Study Evaluating Single-Dose 177LuLu-XT771 Injection Delivered via Ommaya Reservoir for Recurrent Glioblastoma

What this Trial Is About

Researchers are studying the investigational radiopharmaceutical 177LuLu-XT771 in patients with recurrent glioblastoma, a severe brain cancer. This early-phase trial aims to evaluate the safety, dosimetry, and tolerability of this targeted treatment, which delivers radiation directly to tumor cells overexpressing carbonic anhydrase IX and XII. The study will also provide initial data on anti-tumor effects to inform dosing for future trials. Participants will receive a single dose of 177LuLu-XT771 administered locoregionally through an implanted Ommaya reservoir directly into the tumor cavity. Before treatment, a leakage test with a tracer is performed to ensure safety. Patients also receive dexamethasone to prevent cerebral swelling. After injection, participants are isolated until radiation levels are safe, and serial imaging scans are done to monitor drug distribution and absorbed radiation. During the study, participants undergo multiple SPECTCT scans at defined intervals to assess radiation dosimetry. Safety monitoring includes recording adverse events and evaluating tumor response by MRI every 8 weeks. Progression-free survival is tracked for up to one year. The trial involves close follow-up to gather data on safety, pharmacokinetics, and preliminary efficacy over several months.

Dosimetry, Safety, and Efficacy Study of [177Lu]Lu-XT771 in Patients With Recurrent Glioblastoma