GlioblastomaPhase 2NCT04752813
A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)
A Phase 2 study testing BPM31510, Vitamin K1 and Temozolomide (TMZ) in people with Glioblastoma and Glioblastoma Multiforme, run by BPGbio at 11 sites in United States.
Trial summary
This is a single-arm, non-randomized, open-label Phase 2 therapeutic study that will assess the effects of adding BPM31510 onto a conventional treatment framework of RT and concurrent TMZ chemotherapy for subjects with newly diagnosed glioblastoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Glioblastoma Multiforme
- What is being tested?
- BPM31510, Vitamin K1 and Temozolomide (TMZ)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 11 sitesUnited States
- Study dates
- 22 Aug 2022to 26 Aug 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with newly diagnosed pathologically verified GB.
- No prior RT, chemotherapy, immunotherapy, or targeted agents administered specifically for the lesion being treated.
- Age ≥18 y.
- Life expectancy ≥3 months.
- Karnofsky performance score ≥60.
- Adequate organ and marrow function as per protocol.
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- Ability for subject to understand and the willingness to sign a written ICF.
- Subjects of childbearing potential must agree to use hormonal or barrier birth control with spermicidal gel to avoid pregnancy during the study.
- Be at least 15 d out and not more than 50 d from surgery.
Who cannot join
- History of clinically significant tumor-related cerebral hemorrhage.
- Patients with multicentric disease defined by tumors which have multiple discrete areas of contrast-enhancing tumor without connecting T2/FLAIR signal abnormality.
- Patients with diffuse leptomeningeal disease.
- Patients who are not eligible for definitive surgical resection.
- Patients on decadron daily dosing more than 2 mg.
- Any serious cardiac history as per protocol.
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- Uncontrolled or severe coagulopathies or a history of clinically significant bleeding within the past 6 months.
- Known predisposition for bleeding such as von Willebrand's disease or other such condition(s).
- Uncontrolled concurrent illness.
- Prior malignancy except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 3 y prior to first dose of study drug.
- Receiving any of the following medications:
- Therapeutic doses of any anticoagulant, including low-molecular weight heparin. Concomitant use of warfarin, even at prophylactic doses, is prohibited.
- Digoxin, digitoxin, lanatoside C, or any type of digitalis alkaloids.
- Antiangiogenic drugs (ie, Avastin) either in the past 2 wk or if anticipated within the next 2 wk of informed consent.
- Theophylline
- Known allergy to CoQ10.
- Known allergy or adverse reaction to Vitamin K1.
- Pregnant or lactating.
- Known to be positive for the human immunodeficiency virus (HIV). Note: HIV testing is not required for eligibility, but if performed previously and was positive, the subject is ineligible.
- Patients with a contraindication to radiation.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Texas Oncology
Austin, Texas, 78705
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Inova
Fairfax, Virginia, 22037
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Mount Sinai Hospital
New York, New York, 10029
Virginia Oncology Associates
Norfolk, Virginia, 23502
Stanford University Cancer Center
Palo Alto, California, 94305
Valley Health
Ridgewood, New Jersey, 07450
UT Health San Antonio Mays Cancer Center
San Antonio, Texas, 78229
Sansum Clinic
Santa Barbara, California, 93105
About this study
This is a single-arm, non-randomized, open-label Phase 2 therapeutic study that will assess the effects of adding BPM31510 onto a conventional treatment framework of RT and concurrent TMZ chemotherapy for subjects with newly diagnosed glioblastoma.
Read the detailed description
The study will start with a dose-confirmation phase to establish safety of BPM31510 in combination with RT and TMZ. This phase will follow a standard 3+3 dose design with the starting dose of BPM31510 at 110 mg/kg/week (wk), with 1 potential dose de-escalation to 66 mg/kg/wk in the event a DLT is experienced at the 110 mg/kg dose. Toxicity at this dose level will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (CTCAE v5). Subjects will be monitored for DLTs associated with combination therapy for 30 days (d) (± 5 d) after the end of RT (DLT assessment period). Subjects will continue to be monitored for late radiation-related DLTs during follow up, every 8 wk (± 2 wk) during the first 12 months (mo), and then every 12 wk (± 2 wk) for a total of 5 years (y). Safety oversight will be provided by the independent Data and Safety Monitoring Committee (DSMC). The DSMC will review and confirm all DLT data, make recommendations for dose modifications, if necessary, and continue to monitor safety throughout the study. The efficacy phase of the study will begin after the recommended Phase 2 dose (RP2D) has been confirmed.
- Conditions
- Glioblastoma, Glioblastoma Multiforme
- Being tested
- BPM31510, Vitamin K1, Temozolomide (TMZ), Radiation
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPM31510Drug
Subjects will receive a weekly, 96-h infusion of BPM31510 for a duration of 8 weeks.
Vitamin K1Other
Subjects will receive prophylactic Vitamin K1 at a recommended dose of 10 mg subcutaneously prior to the beginning of each week of BPM31510 therapy.
Temozolomide (TMZ)Drug
After 2 wk of treatment with BPM31510 (ie, on Day 15), subjects will start concurrent TMZ 75 mg/m2 once daily (qd) × 42 days. Subjects will receive the standard TMZ treatment for up to 12 cycles post BPM31510 treatment.
RadiationRadiation
After 2 wk of treatment with BPM31510 (ie, on Day 15), subjects will start concurrent standard RT for 42 days.
| Study group | Role | What they receive |
|---|---|---|
| BPM31510, Vitamin K1, RT and TMZ | Experimental | Subjects will receive a BPM31510 96hr infusion once weekly for 8 wk. Prophylactic Vitamin K1 at a recommended dose of 10 mg will be given subcutaneously to all subjects prior to the beginning of each week of therapy.
After 2 wk of treatment with BPM31510, subjects will start concurrent standard RT and TMZ 75 mg/m2 once daily (qd) × 42 days. Subjects will receive the standard TMZ treatment for up to 12 cycles post BPM31510 treatment. Receives: Drug: BPM31510; Other: Vitamin K1; Drug: Temozolomide (TMZ); Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy will be assessed by subject progression free survival
Progression free survival will be determined by measuring the proportion of subjects who have met RANO criteria for complete response, partial response , or stable disease at 6 mo and 12 mo following initiation of BPM31510.
Measured: 6 months and 12 months
Secondary outcomes (2)
Efficacy will be assessed by subject Overall survival
Overall survival as determined by measuring from start date of BPM31510 to the date of death or date of last follow-up (for subjects who have not died).
Measured: 5 years
Safety and tolerability of BPM31510 and Vitamin K1 will be assessed by incidence of dose limiting toxicities (DLTs) and adverse events (AEs).
A DLT is defined as an event possibly related to BPM31510 and clearly not due to an underlying disease or extraneous causes. An AE is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Measured: 30 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start22 Aug 2022
- Primary completion25 Aug 2026 (estimated)
- Study completion26 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BPGbio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752813
- Sponsor's protocol ID
- BPM31510IV-11
- Status last verified
- Sep 2025
- First submitted
- 1 Feb 2021
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)
- ClinicalTrials.gov ID
- NCT04752813
- Acronym / sponsor ID
- BPM31510IV-11
- Conditions
- Glioblastoma, Glioblastoma Multiforme
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- BPGbioIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 25 Aug 2026 (estimated)
- Study completion
- 26 Aug 2030 (estimated)
- First posted
- 12 Feb 2021 (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.
This is a single-arm, non-randomized, open-label Phase 2 therapeutic study that will assess the effects of adding BPM31510 onto a conventional treatment framework of RT and concurrent TMZ chemotherapy for subjects with newly diagnosed glioblastoma.
Detailed description
The study will start with a dose-confirmation phase to establish safety of BPM31510 in combination with RT and TMZ. This phase will follow a standard 3+3 dose design with the starting dose of BPM31510 at 110 mg/kg/week (wk), with 1 potential dose de-escalation to 66 mg/kg/wk in the event a DLT is experienced at the 110 mg/kg dose. Toxicity at this dose level will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (CTCAE v5). Subjects will be monitored for DLTs associated with combination therapy for 30 days (d) (± 5 d) after the end of RT (DLT assessment period). Subjects will continue to be monitored for late radiation-related DLTs during follow up, every 8 wk (± 2 wk) during the first 12 months (mo), and then every 12 wk (± 2 wk) for a total of 5 years (y). Safety oversight will be provided by the independent Data and Safety Monitoring Committee (DSMC). The DSMC will review and confirm all DLT data, make recommendations for dose modifications, if necessary, and continue to monitor safety throughout the study. The efficacy phase of the study will begin after the recommended Phase 2 dose (RP2D) has been confirmed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BPM31510, Vitamin K1, RT and TMZ | Experimental | Drug: BPM31510, Other: Vitamin K1, Drug: Temozolomide (TMZ), Radiation: RadiationSubjects will receive a BPM31510 96hr infusion once weekly for 8 wk. Prophylactic Vitamin K1 at a recommended dose of 10 mg will be given subcutaneously to all subjects prior to the beginning of each week of therapy. After 2 wk of treatment with BPM31510, subjects will start concurrent standard RT and TMZ 75 mg/m2 once daily (qd) × 42 days. Subjects will receive the standard TMZ treatment for up to 12 cycles post BPM31510 treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects with newly diagnosed pathologically verified GB.
- No prior RT, chemotherapy, immunotherapy, or targeted agents administered specifically for the lesion being treated.
- Age ≥18 y.
- Life expectancy ≥3 months.
- Karnofsky performance score ≥60.
Key exclusion criteria (20 listed)
- History of clinically significant tumor-related cerebral hemorrhage.
- Patients with multicentric disease defined by tumors which have multiple discrete areas of contrast-enhancing tumor without connecting T2/FLAIR signal abnormality.
- Patients with diffuse leptomeningeal disease.
- Patients who are not eligible for definitive surgical resection.
- Patients on decadron daily dosing more than 2 mg.
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 |
|---|---|---|
| BPM31510Subjects will receive a weekly, 96-h infusion of BPM31510 for a duration of 8 weeks. | Drug | BPM31510, Vitamin K1, RT and TMZ |
| Vitamin K1Subjects will receive prophylactic Vitamin K1 at a recommended dose of 10 mg subcutaneously prior to the beginning of each week of BPM31510 therapy. | Other | BPM31510, Vitamin K1, RT and TMZ |
| Temozolomide (TMZ)After 2 wk of treatment with BPM31510 (ie, on Day 15), subjects will start concurrent TMZ 75 mg/m2 once daily (qd) × 42 days. Subjects will receive the standard TMZ treatment for up to 12 cycles post BPM31510 treatment. | Drug | BPM31510, Vitamin K1, RT and TMZ |
| RadiationAfter 2 wk of treatment with BPM31510 (ie, on Day 15), subjects will start concurrent standard RT for 42 days. | Radiation | BPM31510, Vitamin K1, RT and TMZ |
Primary outcome
Efficacy will be assessed by subject progression free survival
Time frame: 6 months and 12 months
Progression free survival will be determined by measuring the proportion of subjects who have met RANO criteria for complete response, partial response , or stable disease at 6 mo and 12 mo following initiation of BPM31510.
2 secondary outcomes
Efficacy will be assessed by subject Overall survival
Time frame: 5 years
Safety and tolerability of BPM31510 and Vitamin K1 will be assessed by incidence of dose limiting toxicities (DLTs) and adverse events (AEs).
Time frame: 30 days post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
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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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BPM31510, Vitamin K1 and Temozolomide (TMZ) in people with Glioblastoma and Glioblastoma Multiforme, run by BPGbio at 11 sites in United States.
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 9 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Efficacy will be assessed by subject progression free survival (time frame: 6 months and 12 months). 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 26 Jan 2026.