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)

Phase 1

• Conditions: Gliosarcoma; Glioblastoma Multiforme; Diffuse Midline Glioma, H3 K27M-Mutant; Giant Cell Glioblastoma; GBM
• Interventions: Biological: S-Gboxin

• Registration Number: NCT06806228
• Lead Sponsor: Petrov, Andrey

Brief 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.

Study Timeline

• Study First Submitted: 2025-01-26
• Study First Submitted QC: 2025-01-31
• Study First Posted: 2025-02-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-02
• Last Update Posted: 2025-03-04
• Study Start: 2025-04-11
• Primary Completion: 2025-11-09
• Study Completion: 2025-12-19

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• confirmed diagnosis of Glioblastoma according to RANO criteria by contrast-enhanced MRI or PET-CT (including diffuse midline glioma, gliosarcoma or giant cell glioblastoma), relapse or disease progression
• patient is able to understand and give consent to participate in the study
• Karnofsky performance score ≥ 60
• women of childbearing potential must have a negative pregnancy test result no later than 7 days before registration

Exclusion Criteria

• pregnant
• known allergies
• active treatment on annotner clinical trial
• inability to complete with protocol or studio procedures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients will be offered 4 courses of Gboxin during (or without) standard treatment.	S-Gboxin	Patients will be offered 4 courses of S-Gboxin during standard treatment. Each course (18 days) consists of twice daily intake of S-Gboxin for 14 days and four days of rest. Each dose of S-Gboxin is packed in a gelatin capsule with a bandage and applied markings.

Primary Outcome Measures

Name	Time	Method
Brain tumor metabolism as measured by PET and MRI	Up to 6 month	The standardized uptake value (SUV) of HGG will be measured. SUV is a standard PET measurement. MRI with contrast will evaluate the change in tumor size before and after therapy S-Gboxin

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	Up to 12 month	Kaplan-Meier survival estimates for OS will be presented with using Greenwood's formula at 12 months.
Incidence of adverse events graded according to the Common Toxicity Criteria for Adverse Events (CTCAE) version (v)4.03	Up to 1 month after last dose of S-Gboxin	The data will be organized by major organ system and MedDRA severity after completion of the Clinical Study.

Trial Locations

Locations (3)

Tbilisi Cancer Centre; 🇬🇪 Tbilisi, Georgia

Kazakh Institute of Oncology and Radiology; 🇰🇿 Almaty, Kazakhstan

National Cancer Institute; 🇺🇦 Kyiv, Ukraine