NCT07515924

Oral Gallium Maltolate for Recurrent Glioblastoma

A Phase 0 Clinical Trial of Oral Gallium Maltolate for Recurrent Glioblastoma

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 0 investigational study to assess the central nervous system penetration and tumoral concentration of gallium in patients with recurrent glioblastoma administered with preoperative gallium maltolate.

Detailed description

Rationale: Currently, recruitment has concluded for a Phase 1 trial assessing in patients with GBM. Preliminary analyses have demonstrated gallium maltolate is both safe and potentially efficacious in treating glioblastoma. However, while gallium maltolate has been well-tolerated, further correlative analyses are necessary to confirm the drug's ability to act within the brain.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	Gallium Maltolate	Gallium Maltolate will be administered at a total daily dose of 2500 mg.
PROCEDURE	Surgical Intervention	Patients will be scheduled for surgical intervention (needle biopsy or resection) as deemed necessary by the clinical team after 14 ± 5 days of oral Gallium Maltolate administration.

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study