Expanded Access to Gallium Maltolate (GaM)
NCT06404034 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2026-03-04
Summary
The objective of this program is to provide GaM for compassionate use in patients with relapsed/refractory histologic or molecular glioblastoma who have exhausted available treatments.
The population of this program is adult patients aged greater than or equal to 18 years with a diagnosis of relapsed/refractory histologic or molecular glioblastoma, according to the WHO 2021 diagnostic criteria.
Molecular glioblastoma is characterized as an IDH-wildtype diffuse and astrocytic glioma in adults if there is microvascular proliferation or necrosis or TERT promoter mutation or EGFR gene amplification or +7/-10 chromosome copy number changes
Conditions
- Glioblastoma
- Refractory Glioblastoma
- Glioblastoma Multiforme
Interventions
- DRUG
-
Gallium Maltolate
GaM will be provided as 500 mg capsules and will be self-administered once daily by mouth at the assigned dose level on a 28-day cycle (one cycle is 28 days) on an empty stomach. GaM should be taken at least 60 minutes before a meal and at least two hours after a meal. Liquids are allowed
Sponsors & Collaborators
-
xCures
collaborator INDUSTRY -
Imaging Biometrics, LLC
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- United States
Study Locations
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