Phase I Study of 177LuLu-DOTA-EB-RGD2 Administered Intravenously or Into Tumor Cavity to Treat Recurrent High-Grade Glioma

What this Trial Is About

Researchers are evaluating a new radiopharmaceutical called 177LuLu-DOTA-EB-RGD2 in patients with recurrent high-grade gliomas, including recurrent glioblastoma IDH wildtype. This Phase I clinical trial aims to determine the safety, tolerability, dosimetry, and early anti-tumor effects of this drug. The study uses a dose-escalation design to find the maximum tolerated dose through two different delivery methods intravenous infusion and direct injection into the tumor cavity using an Ommaya reservoir. Participants receive 177LuLu-DOTA-EB-RGD2 either via an intravenous infusion lasting 20 to 30 minutes or through a previously implanted Ommaya reservoir directly into the tumor cavity. Treatments are given every three weeks for up to two cycles, with three dose levels tested per route. Additional treatment cycles may be offered based on the clinical benefit observed. The study is conducted at two Chinese medical centers and includes approximately 24 patients. During the trial, participants undergo regular assessments including MRI scans to monitor tumor response, blood and urine tests for pharmacokinetics and dosimetry, and evaluation of any adverse events. Researchers measure dose-limiting toxicities within six weeks after the first dose and monitor overall survival and objective response rates over up to 17 months. Safety, drug distribution, and effectiveness indicators are closely followed throughout treatment and follow-up periods.

[177Lu]Lu-DOTA-EB-RGD2 Therapy in Patients With Recurrent High-grade Glioma