Expanded Access to Gallium Maltolate (GaM)

Available (expanded access)

Conditions studied: Glioblastoma, Refractory Glioblastoma, Glioblastoma Multiforme

In brief

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

Key facts

Study ID

NCT06404034

Run by

Imaging Biometrics, LLC

Last updated by the study team

2026-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient has relapsed/refractory histologic or molecular glioblastoma who, in the opinion of the treating physician, may benefit from treatment from GaM.
• Male or female patient aged ≥ 18 years.
• In the opinion of the treating physician, the patient has adequate organ function to tolerate GaM.
• Patient must be able to swallow and retain orally administered medication.
• For females of childbearing potential, negative urinary or serum pregnancy test.
• Patients must be willing to highly effective contraception for both male and female patients throughout the treatment and for at least 4 months after last treatment administration.
• Toxicities related to any prior treatments are either stable, stable on supportive therapy, resolved, or in the opinion of the treating physician, clinically non-significant.
• Ability to understand a written informed consent document, and the willingness to sign it by the patient or legally authorized patient representative (LAR) or guardian.
• Informed consent obtained for the XCELSIOR longitudinal outcomes registry (NCT03793088)

You may not qualify if…

• Patient is already participating in or is able to enroll in a clinical trial of GaM.
• Patient has received systemic therapy with an investigational agent within 5 half-lives or 14 days prior to starting GaM treatment, whichever is shorter.
• Patients completing radiotherapy treatment less than 14 days prior to planned study treatment initiation.
• Patient is taking oral iron supplements or iron chelators.
• Current evidence of uncontrolled, significant intercurrent illness that would, in the treating physician's judgment, contraindicate the patient's treatment with GaM due to safety concerns.
• Patients who, in the opinion of the treating physician, have not fully recovered from recent major surgery to a sufficient extent to tolerate treatment with GaM.
• Known hypersensitivity to GaM or any component in its formulation.
• Patients taking prohibited medications as described in the current Investigator's Brochure.
• Patient is pregnant or actively breastfeeding

Where it is running

• University of Miami Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Cancer Partners of Nebraska — Lincoln, Nebraska, United States
• Northwell Health — New York, New York, United States

Full record on ClinicalTrials.gov

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