drugset / Trial / NCT07061626

Determine Maximum Tolerated Dose, Safety, and Tolerability of Rhenium (186Re) in Pediatric Recurrent, Refractory or Progressive Ependymoma and High-Grade Glioma

NCT07061626 ↗

Non-randomizedSequentialOpen-labelTreatment

Summary

Pediatric patients 6-21 years of age with supratentorial recurrent, refractory, or progressive pediatric ependymoma and high-grade glioma (HGG) will be included in this study of treatment with Rhenium-186 Nanoliposome (186RNL). Phase 1 of the study will look to determine the maximum tolerated dose (MTD) of 186RNL in this patient population. Phase 2 of the study will use the recommended dose determined in Phase 1 to continue to look at overall response rate and progression-free survival following 186RNL treatment.

Timeline

Start
2025-09
Primary completion
2027-03
Completion
2027-03

Drugs

EvaluationDrugModalityDoseRoute
Subject 186RNL Other / unclassified 18.5 mbq Other
Subject 186RNL Other / unclassified 37 mbq Other
Subject 186RNL Other / unclassified 92.5 mbq Other