drugset / Trial / NCT07061626
Determine Maximum Tolerated Dose, Safety, and Tolerability of Rhenium (186Re) in Pediatric Recurrent, Refractory or Progressive Ependymoma and High-Grade Glioma
Phase 1
Not yet recruiting
56 enrolled
Plus Therapeutics
Ann & Robert H Lurie Children's Hospital of Chicago · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 186RNL | Other / unclassified | 18.5 mbq | Other |
| Subject | 186RNL | Other / unclassified | 37 mbq | Other |
| Subject | 186RNL | Other / unclassified | 92.5 mbq | Other |