Glioblastoma MultiformePhase 1NCT06806228
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)
A Phase 1 study testing S-Gboxin in people with Glioblastoma Multiforme and Diffuse Midline Glioma, H3 K27M-Mutant, run by Petrov, Andrey at 3 sites in 3 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Glioblastoma Multiforme, Diffuse Midline Glioma, H3 K27M-Mutant, Gliosarcoma
- What is being tested?
- S-Gboxin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 20 May 2026to 10 Dec 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnant
- known allergies
- active treatment on annotner clinical trial
- inability to complete with protocol or studio procedures.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Kazakhstan1 site
Kazakh Institute of Oncology and Radiology
Almaty, 490 078
About this study
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
Read the 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
- Being tested
- S-Gboxin
- Medical subject headings
- Glioblastoma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-GboxinBiological
Also called oxidative phosphorylation inhibitor, OXPHOS inhibitor, suppression of oxidative phosphorylation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: S-Gboxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 6 month
Secondary outcomes (2)
Overall survival (OS)
Kaplan-Meier survival estimates for OS will be presented with using Greenwood's formula at 12 months.
Measured: Up to 12 month
Incidence of adverse events graded according to the Common Toxicity Criteria for Adverse Events (CTCAE) version (v)4.03
The data will be organized by major organ system and MedDRA severity after completion of the Clinical Study.
Measured: Up to 1 month after last dose of S-Gboxin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start20 May 2026
- Primary completion10 Oct 2027 (estimated)
- Study completion10 Dec 2027 (estimated)
Why it stopped: The study protocol will be changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Petrov, Andrey
- Sponsor type
- University, hospital or other
- Collaborators
- Lytvin,Ruslan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806228
- Sponsor's protocol ID
- STM 0125-2G
- Status last verified
- May 2026
- First submitted
- 26 Jan 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes