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AVAILABLE
NCT06404034

Expanded Access to Gallium Maltolate (GaM)

Sponsor: Imaging Biometrics, LLC

View on ClinicalTrials.gov

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

Official title: Expanded Access to Gallium Maltolate (GaM) for Adult Patients With Relapsed/Refractory Histologic or Molecular Glioblastoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

EXPANDED_ACCESS

Enrollment

Not specified

Start Date

Not specified

Completion Date

Not specified

Last Updated

2026-06-08

Healthy Volunteers

Not specified

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

Locations (3)

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