NCT05610891

Novel Targeted Radiotherapy in Pediatric Patients With Inoperable Relapsed or Refractory HGG

A Phase 1b, Open-Label, Study of a Novel Targeted Radiotherapy in Children, Adolescents and Young Adults With Inoperable Relapsed or Refractory High-Grade Glioma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Cellectar Biosciences, Inc. · Industry
• Sex: All
• Age: 10 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this dose finding study is to evaluate the safety and efficacy of 2 different dose levels of CLR 131 in children, adolescents and young adults with relapsed or refractory high-grade glioma (HGG).

Detailed description

This study is designed to further evaluate the safety and tolerability of CLR 131 at the selected doses in children, adolescents and young adults with relapsed or refractory malignant high-grade glioma. It will also determine the therapeutic activity defined as progression free survival and overall survival, antitumor activity (treatment response) defined as the reduction in tumor volume and identify the recommended Phase 2/3 dose of CLR 131 in children, adolescents and young adults with relapsed or refractory HGG.

Conditions

• High-Grade Glioma

Interventions

Type	Name	Description
DRUG	CLR 131	CLR 131 will be administered IV (intravenously) at a dose based on patients' BSA

Timeline

• Start date: 2023-10-01
• Primary completion: 2026-05-01
• Completion: 2026-09-01
• First posted: 2022-11-09
• Last updated: 2026-03-18

Locations

8 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study