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)

NCT06806228 | Suspended Phase 1

• 1 other identifier: STM 0125-2G
• Study Type: interventional
• Target: 10
• Locations: 3 countries
• Sites: 3

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Brain tumor metabolism as measured by PET and MRI

  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

  Up to 6 month

Secondary Outcomes (2)

• Overall survival (OS)

  Up to 12 month

• 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

Study Arms (1)

Patients will be offered 4 courses of Gboxin during (or without) standard treatment.

EXPERIMENTAL

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.

Biological: S-Gboxin

Interventions

S-Gboxin BIOLOGICAL

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.

Also known as: oxidative phosphorylation inhibitor, OXPHOS inhibitor, suppression of oxidative phosphorylation

Patients will be offered 4 courses of Gboxin during (or without) standard treatment.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Petrov, Andrey: lead
• Lytvin,Ruslan: collaborator

Study Sites (3)

Tbilisi Cancer Centre

Tbilisi, 0198, Georgia

Location

Kazakh Institute of Oncology and Radiology

Almaty, 490 078, Kazakhstan

Location

National Cancer Institute

Kyiv, 33/43, Ukraine

Location

Related Links

• Gboxin is an oxidative phosphorylation inhibitor that targets glioblastoma
• Cancer cell-mitochondria hybrid membrane coated Gboxin loaded nanomedicines for glioblastoma treatment
• Nanomedicine and Immunotherapy for recurrent glioblastoma

MeSH Terms

Conditions

Glioblastoma; Gliosarcoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2025
• First Posted: February 4, 2025
• Study Start: March 20, 2026
• Primary Completion (Estimated): October 10, 2027
• Study Completion (Estimated): December 10, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: documents will be available 3 months after completion of the research
• Access Criteria: free access

Locations

UA (1); KA (1); GE (1)