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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06806228
- Acronym / sponsor ID
- STM 0125-2G
- Conditions
- Glioblastoma Multiforme, Diffuse Midline Glioma, H3 K27M-Mutant, Gliosarcoma, Giant Cell Glioblastoma, GBM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The study protocol will be changed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Petrov, AndreyUniversity, hospital or other
- Collaborators
- Lytvin,Ruslan
- Study start
- 20 May 2026 (actual)
- Primary completion
- 10 Oct 2027 (estimated)
- Study completion
- 10 Dec 2027 (estimated)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients will be offered 4 courses of Gboxin during (or without) standard treatment. | Experimental | Biological: S-GboxinPatients 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- pregnant
- known allergies
- active treatment on annotner clinical trial
- inability to complete with protocol or studio procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-GboxinAlso: oxidative phosphorylation inhibitor, OXPHOS inhibitor, suppression of oxidative phosphorylationGboxin 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. | Biological | Patients will be offered 4 courses of Gboxin during (or without) standard treatment. |
Primary outcome
Brain tumor metabolism as measured by PET and MRI
Time frame: 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
2 secondary outcomes
Overall survival (OS)
Time frame: Up to 12 month
Incidence of adverse events graded according to the Common Toxicity Criteria for Adverse Events (CTCAE) version (v)4.03
Time frame: Up to 1 month after last dose of S-Gboxin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Gboxin is an oxidative phosphorylation inhibitor that targets glioblastomaLink provided by the sponsor.
- Cancer cell-mitochondria hybrid membrane coated Gboxin loaded nanomedicines for glioblastoma treatmentLink provided by the sponsor.
- Nanomedicine and Immunotherapy for recurrent glioblastomaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Georgia, Kazakhstan, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain tumor metabolism as measured by PET and MRI (time frame: Up to 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.