NCT06806228

Phase I Pilot Study to Evaluate the Anti-glioblastoma Effect of S-Gboxin in Standard Treatment of Glioblastoma/Diffuse Midline Glioma and Response to Treatment (Regardless of Mutation Status)

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Petrov, Andrey · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The objective of this pilot study is to evaluate the efficacy of adding S-Gboxin to standard RT/TMZ treatment protocols in patients with glioblastoma multiforme (GBM) or midline glioma (DMG), regardless of their mutation status

Detailed description

This is a pilot study to evaluate the efficacy of adding the mitochondrial oxidative phosphorylation inhibitor S-Gboxin (OXPHOS) to standard treatment for glioblastoma multiforme or glioma. Subjects will start oral S-gboxin orally twice daily and will evaluate the patients and vital status if they tolerate this dose at 3, 7and 15 days after initiation. Patients will undergo MRI scans before treatment and then at multiple time points during their participation in this Clinical Trial to monitor early tumor response to treatment ( MRI dates will be scheduled by the clinical trial coordinator) Peripheral blood samples will be collected at baseline, days 1-7-15-28-36-72 to compare biological indicators of treatment response. In some cases, circulating tumor cells (CTCs) will be monitored by real-time qRT-PCR to correlate with clinical data. Patients will also be assessed for the side effects they experience. Disease-free and overall survival outcomes will be recorded. Patients will also have their depressive symptoms, quality of life, and neurocognitive function assessed at multiple time points during and after treatment. After completion of the study, patients will be followed up at 3 months.

Conditions

• Glioblastoma Multiforme
• Diffuse Midline Glioma, H3 K27M-Mutant
• Gliosarcoma
• Giant Cell Glioblastoma
• GBM

Interventions

Type	Name	Description
BIOLOGICAL	S-Gboxin	Gboxin specifically inhibits the growth of human glioblastoma cells but not normal cells. Gboxin rapidly and irreversibly impairs oxygen consumption in glioblastoma cells. Its positive charge for binding to mitochondrial oxidative phosphorylation complexes is dependent on the proton gradient of the inner mitochondrial membrane, and it inhibits F 0 F 1 ATP synthase activity in tumor cells. S-Gboxin crosses the blood-brain barrier at therapeutically effective concentrations.

Timeline

• Start date: 2026-03-20
• Primary completion: 2027-10-10
• Completion: 2027-12-10
• First posted: 2025-02-04
• Last updated: 2025-11-19

Locations

3 sites across 3 countries: Georgia, Kazakhstan, Ukraine