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AvailableNCT06404034Updated Jun 8, 2026

Expanded Access to Gallium Maltolate (GaM)

An expanded access record providing Gallium Maltolate in Glioblastoma, Refractory Glioblastoma and Glioblastoma Multiforme, sponsored by Imaging Biometrics, LLC. Available at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.

Sponsored by Imaging Biometrics, LLC · Expanded access

Study type
Expanded access
Access type
Intermediate-size population
Ages
18 Years and older
Sex
All
01

Study 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

Read the detailed description

This is an intermediate-sized expanded access treatment protocol. GaM (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). Initially, the patients will be provided a three (3) cycle prescription (a 28-day supply with two refills); enough total supply of GaM for three full cycles to allow for self-administration at home. It should be taken on an empty stomach. After that initial period, subsequent GaM will be provided to patients for continued self-administration.

At the treating physician's discretion, additional medication(s) may be administered. Clinical use of cancer-supportive care therapies is unrestricted, but the non-emergent use of additional anti-cancer therapies requires prior consultation with xCures and Imaging Biometrics. xCures along with Imaging Biometrics will be consulted prior to the non-emergent administration of any additional anti-cancer medications. xCures, along with Imaging Biometrics, should be consulted prior to any schedule modifications or the addition of other therapy. The patients may discontinue therapy at any time for any reason. The treating physician can discontinue therapy with GaM at any time for any reason.

02

Conditions studied

  • Glioblastoma
  • Refractory Glioblastoma
  • Glioblastoma Multiforme

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Keywords

  • glioblastoma
  • refractory glioblastoma
03

In context

Glioblastoma

1,919 studies on the registry are indexed under Glioblastoma; 449 are open to participants now.

Browse Glioblastoma studies →

Lead sponsor

This is the only study on the registry with Imaging Biometrics, LLC as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

Inclusion criteria

  1. Patient has relapsed/refractory histologic or molecular glioblastoma who, in the opinion of the treating physician, may benefit from treatment from GaM.
  2. Male or female patient aged ≥ 18 years.
  3. In the opinion of the treating physician, the patient has adequate organ function to tolerate GaM.
  4. Patient must be able to swallow and retain orally administered medication.
  5. For females of childbearing potential, negative urinary or serum pregnancy test.
  6. 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.
  7. 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.
  8. 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.
  9. Informed consent obtained for the XCELSIOR longitudinal outcomes registry (NCT03793088)

Exclusion criteria

Exclusion Criteria:

  1. Patient is already participating in or is able to enroll in a clinical trial of GaM.
  2. Patient has received systemic therapy with an investigational agent within 5 half-lives or 14 days prior to starting GaM treatment, whichever is shorter.
  3. Patients completing radiotherapy treatment less than 14 days prior to planned study treatment initiation.
  4. Patient is taking oral iron supplements or iron chelators.
  5. 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.
  6. 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.
  7. Known hypersensitivity to GaM or any component in its formulation.
  8. Patients taking prohibited medications as described in the current Investigator's Brochure.
  9. Patient is pregnant or actively breastfeeding
05

Access details

Study type
Expanded access
Access type
Intermediate-size population

Available treatment

  • DrugGallium 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

    Also known as: GaM

06

Where to request access

3 of 3 sites recruiting
  • University of Miami Sylvester Comprehensive Cancer Center
    Miami, Florida 33136, United States
    • Dr. Macarena De La Fuente, MD · Contact · 305-243-0864
    Available
  • Cancer Partners of Nebraska
    Lincoln, Nebraska 68516, United States
    • Brett Greib, MD · Contact
    Available
  • Northwell Health
    New York, New York 10075, United States
    • Tamika A. Wong, MPH · Contact · 212-434-4836
    • Dr. John Boockvar, MD · Principal investigator
    Available
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT06404034
Lead sponsor
Imaging Biometrics, LLC
Collaborators
xCures
Responsible party
Sponsor
First posted
May 8, 2024
Last update
Jun 8, 2026

Study contacts

Imaging Biometrics, LLC
Contact
eap@imagingbiometrics.com
262-439-8252
Imaging Biometrics, Inc.
Contact
eap@imagingbiometrics.com
262-439-8252
View the source record on ClinicalTrials.gov ↗

Requesting access

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