NCT07331064

Gallium Maltolate for the Treatment of Pediatric Patients With Relapsed or Refractory Pediatric High-Grade Glioma and Atypical Teratoid Rhabdoid Tumor

A Phase 1 Clinical Trial of Gallium Maltolate for the Treatment of Pediatric Patients With Relapsed or Refractory Pediatric High-Grade Glioma and Atypical Teratoid Rhabdoid Tumor

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Sarah Rumler · Academic / Other
• Sex: All
• Age: 0 Months – 17 Years
• Healthy volunteers: Not accepted

Summary

In this study, we want to find out more about the side effects of an investigational drug for relapsed or refractory atypical teratoid rhabdoid tumor and high-grade glioma, Gallium Maltolate (GaM) and what doses of GaM are safe for people to take. Everyone in this study will receive GaM which is still experimental and is not approved by the U.S. Food and Drug Administration. We do not know all the ways that this drug may affect people. We hope the information from this study will help us develop a better treatment for relapsed or refractory atypical teratoid rhabdoid tumor and high-grade glioma in the future.

Detailed description

We hypothesize that Gallium Maltolate (GaM) can be safely administered for the treatment of pediatric patients with pHGGs and ATRTs that have relapsed following primary treatment or are refractory to primary treatment. This, in turn, will be manifested by antineoplastic activity in patients as measured by progression-free survival (PFS) and overall survival (OS).

Conditions

• High Grade Gliomas
• Atypical Teratoid Rhabdoid Tumors (ATRT)
• Diffuse Midline Glioma
• DIPG
• Diffuse Intrinsic Pontine Gliomas (DIPG)

Interventions

Type	Name	Description
DRUG	Gallium maltolate	oral small-molecule iron mimetic

Timeline

• Start date: 2026-05-15
• Primary completion: 2030-11-15
• Completion: 2031-05-15
• First posted: 2026-01-09
• Last updated: 2026-01-09

Regulatory

• FDA-regulated drug study