GaM-GBM Black African Phase 1 Study

A Phase 1 Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Gallium Maltolate in Adult Black African Patients with Relapsed or Treatment-Refractory Glioblastoma Multiforme (GBM)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

PACTR

Registry ID

PACTR202509858954027

Enrollment

Registered

2025-09-30

Start date

2025-09-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Interventions

Gallium Maltolate in African patients who progressed on the standard treatment options

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically con?rmed glioblastoma multiforme (GBM) (WHO Grade IV). Age =18 years at time of consent. Relapsed or treatment-refractory disease following standard-of-care therapy (surgical resection, radiation, and temozolomide). Karnofsky Performance Status (KPS) = 50. Life expectancy of =12 weeks. Adequate organ function as de?ned by: Absolute neutrophil count (ANC) = 1.5 × 10?/L Platelet count = 100 × 10?/L Hemoglobin = 9.0 g/dL AST/ALT = 2.5 × ULN Total bilirubin = 1.5 × ULN Serum creatinine = 1.5 × ULN or creatinine clearance = 50 mL/min Negative serum pregnancy test for women of childbearing potential. Agreement to use highly effective contraception for the duration of the study and for 3 months after ?nal dose. Able and willing to provide informed consent.

Exclusion criteria

Exclusion criteria: Prior exposure to Gallium Maltolate or other investigational iron-mimetic therapies. Concurrent participation in another interventional clinical trial. Active, uncontrolled infection including HIV, HBV, or HCV. Uncontrolled intercurrent illness including symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia. Known CNS hemorrhage or untreated hydrocephalus. Pregnant or breastfeeding. Any condition which, in the opinion of the investigator, would interfere with the evaluation of the study drug or interpretation of patient safety or study results.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety, tolerability, and determine the Maximum Tolerated Dose (MTD) of orally administered Gallium Maltolate in adult Black African patients with relapsed or treatment-refractory glioblastoma multiforme (GBM).	—

Secondary

Measure	Time frame
To characterize the pharmacokinetic (PK) pro?le of Gallium Maltolate following daily oral administration. To evaluate preliminary signs of antitumor activity (e.g., radiographic stability or response) using standardized imaging criteria. To assess CNS-speci?c tolerability and symptom burden throughout treatment.	—

Countries

Nigeria

Contacts

Public ContactBenedict Agbo

Co investigator MeCure cancer center

dragbo@mecure.com.ng+2347000532873

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026