Malignant Neoplasm of BrainPhase 1/2NCT07569042
A Rollover Study of NBM-BMX in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma
A Phase 1/2 study testing NBM-BMX Capsule and Temozolomide in people with Malignant Neoplasm of Brain, run by Novelwise Pharmaceutical Corporation at 3 sites in Taiwan.
Trial summary
This clinical trial is a rollover study designed to provide continued access to NBM-BMX and temozolomide (TMZ) for eligible participants with newly diagnosed glioblastoma who have completed the designated treatment in Study NBM-BMX-003 (the parent study), and to evaluate the long-term safety and efficacy of NBM-BMX… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm of Brain
- What is being tested?
- NBM-BMX Capsule and Temozolomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesTaiwan
- Study dates
- 20 Apr 2026to 31 Dec 2030
- Phase
- Phase 1/2
- 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
- Participants must meet all of the following criteria to be eligible for the study:
- Have completed or currently enrolled in Arm B of Study NBM-BMX-003 (the parent study), and in the opinion of the Investigator, may derive clinical benefit from continued treatment with study drugs.
- Histologically confirmed glioblastoma.
- Can enroll into this rollover study within 35 days after completing the last dose of NBM-BMX in the parent study.
- Have signed and dated the informed consent form.
- Karnofsky performance status (KPS) ≥ 60 at enrollment in this study.
Show all 17Show fewer
- Adequate organ functions as defined by the following criteria:
- Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 × upper limit of normal (ULN)
- Total serum bilirubin ≤ 1.5 × ULN unless bilirubin elevation is related to Gilbert's Syndrome for which bilirubin ≤ 3 × ULN
- Absolute neutrophil count (ANC) ≥ 1,000/µL
- Platelets ≥ 75,000/µL
- Hemoglobin ≥ 8.0 g/dL
- Non-indexed estimated glomerular filtration rate (eGFR) ≥ 50 mL/min
- Women of childbearing potential must have a negative pregnancy test performed within 14 days before the first dose of this study.
- Men and women of childbearing potential must agree to use acceptable contraceptive methods throughout the study period and for at least 6 months after the final dose of temozolomide.
- Acceptable contraceptive methods include implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical sterilization or a partner who is sterile.
- Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
Who cannot join
- Participants with any of the following will be excluded from the study:
- Currently receive or plan to receive anti-cancer treatments other than the study drugs including Gliadel wafer implant or tumor treating fields (TTFields).
- Permanently discontinued from the parent study due to unacceptable toxicity, non-compliance with study procedures, withdrawal of consent, or any other reason.
- A positive test for hepatitis B (HBsAg) and/or hepatitis C (anti-HCV antibody), unless the HBV DNA level and/or HCV RNA level is below the limit of detection.
- QTcF > 480 msec
- Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.
Show all 10Show fewer
- Have known hypersensitivity reaction to temozolomide, dacarbazine or NBM-BMX.
- Have difficulty swallowing (including those require nasogastric tube) or with impaired absorption of oral medications.
- Female who are pregnant or breastfeeding.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would impart, in the judgement of the Investigator and/or sponsor, excess risks associated with study participation or study drug administration.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan3 sites, 3 recruiting
- Not yet recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Ann-Shung Lieu, M.D., +886 7 3121101
- Not yet recruiting
Taichung Veterans General Hospital
Taichung, 407
Wen-Yu Cheng, M.D., +886 4 23592525
- Recruiting
Linkou Chang-Gung Memorial Hospital
Taoyuan City, 333
Kuo-Chen Wei, M.D., +886 3 3281200
About this study
Official title: A Rollover Study to Evaluate the Long-Term Safety and Efficacy of NBM-BMX in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma Who Completed Study NBM-BMX-003 (the Parent Study)
This clinical trial is a rollover study designed to provide continued access to NBM-BMX and temozolomide (TMZ) for eligible participants with newly diagnosed glioblastoma who have completed the designated treatment in Study NBM-BMX-003 (the parent study), and to evaluate the long-term safety and efficacy of NBM-BMX administered in combination with TMZ.
Read the detailed description
This is a multi-center, open-label, single-arm, rollover study designed to provide participants with newly diagnosed glioblastoma who have completed Study NBM-BMX-003 (the parent study) with continued access to study treatment. Eligible participants will transition into this study to continue receiving study drugs (NBM-BMX and temozolomide) at the same doses and schedules as in the parent study.
For participants enrolled in the dose-escalation cohorts of the parent study who received lower doses of NBM-BMX, escalation to a higher dose demonstrated to be safe in the parent study may be permitted with Sponsor approval.
Participants may continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or up to 12 cycles of treatment, whichever occurs first.
- Conditions
- Malignant Neoplasm of Brain
- Being tested
- NBM-BMX Capsule, Temozolomide
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBM-BMX CapsuleDrug
Each capsule contains 100 mg of the active ingredient.
TemozolomideDrug
Also called TMZ
Temodal will be administered orally at a 75 mg/m2 dose daily during concomitant therapy. In the maintenance period, days 1-5 of each cycle will be administered 150-200 mg/m2.
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy in glioblastoma | Experimental | Subjects with newly diagnosed glioblastoma who have completed Study NBM-BMX-003 will transition into this study to continue receiving study drugs (NBM-BMX and temozolomide) at the same doses and schedules as in the parent study. Receives: Drug: NBM-BMX Capsule; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency, types, severity, and relationship to NBM-BMX of adverse events (AEs)
To evaluate the long-term safety and tolerability of NBM-BMX in combination with temozolomide.
Measured: Through study completion, an average of 1 year.
Progression-free survival (PFS) and overall survival (OS)
To assess the preliminary long-term efficacy of the combination therapy.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start20 Apr 2026
- Primary completion30 Sep 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasm of BrainStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novelwise Pharmaceutical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569042
- Sponsor's protocol ID
- NBM-BMX-005
- Status last verified
- May 2026
- First submitted
- 24 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Rollover Study to Evaluate the Long-Term Safety and Efficacy of NBM-BMX in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma Who Completed Study NBM-BMX-003 (the Parent Study)
- ClinicalTrials.gov ID
- NCT07569042
- Acronym / sponsor ID
- NBM-BMX-005
- Conditions
- Malignant Neoplasm of Brain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Novelwise Pharmaceutical CorporationIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 6 May 2026 (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 clinical trial is a rollover study designed to provide continued access to NBM-BMX and temozolomide (TMZ) for eligible participants with newly diagnosed glioblastoma who have completed the designated treatment in Study NBM-BMX-003 (the parent study), and to evaluate the long-term safety and efficacy of NBM-BMX administered in combination with TMZ.
Detailed description
This is a multi-center, open-label, single-arm, rollover study designed to provide participants with newly diagnosed glioblastoma who have completed Study NBM-BMX-003 (the parent study) with continued access to study treatment. Eligible participants will transition into this study to continue receiving study drugs (NBM-BMX and temozolomide) at the same doses and schedules as in the parent study.
For participants enrolled in the dose-escalation cohorts of the parent study who received lower doses of NBM-BMX, escalation to a higher dose demonstrated to be safe in the parent study may be permitted with Sponsor approval.
Participants may continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or up to 12 cycles of treatment, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination therapy in glioblastoma | Experimental | Drug: NBM-BMX Capsule, Drug: TemozolomideSubjects with newly diagnosed glioblastoma who have completed Study NBM-BMX-003 will transition into this study to continue receiving study drugs (NBM-BMX and temozolomide) at the same doses and schedules as in the parent study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Have completed or currently enrolled in Arm B of Study NBM-BMX-003 (the parent study), and in the opinion of the Investigator, may derive clinical benefit from continued treatment with study drugs.
- Histologically confirmed glioblastoma.
- Can enroll into this rollover study within 35 days after completing the last dose of NBM-BMX in the parent study.
- Have signed and dated the informed consent form.
- Karnofsky performance status (KPS) ≥ 60 at enrollment in this study.
Key exclusion criteria (10 listed)
- Currently receive or plan to receive anti-cancer treatments other than the study drugs including Gliadel wafer implant or tumor treating fields (TTFields).
- Permanently discontinued from the parent study due to unacceptable toxicity, non-compliance with study procedures, withdrawal of consent, or any other reason.
- A positive test for hepatitis B (HBsAg) and/or hepatitis C (anti-HCV antibody), unless the HBV DNA level and/or HCV RNA level is below the limit of detection.
- QTcF > 480 msec
- Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.
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 |
|---|---|---|
| NBM-BMX CapsuleEach capsule contains 100 mg of the active ingredient. | Drug | Combination therapy in glioblastoma |
| TemozolomideAlso: TMZTemodal will be administered orally at a 75 mg/m2 dose daily during concomitant therapy. In the maintenance period, days 1-5 of each cycle will be administered 150-200 mg/m2. | Drug | Combination therapy in glioblastoma |
Primary outcome
Frequency, types, severity, and relationship to NBM-BMX of adverse events (AEs)
Time frame: Through study completion, an average of 1 year.
To evaluate the long-term safety and tolerability of NBM-BMX in combination with temozolomide.
Progression-free survival (PFS) and overall survival (OS)
Time frame: Through study completion, an average of 1 year.
To assess the preliminary long-term efficacy of the combination therapy.
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 6 May 2026.
Related trials for Malignant Neoplasm of Brain
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
Active, not recruitingPhase 2
Genetic Testing in Guiding Treatment for Patients With Brain Metastases
CDK Gene Mutation, Metastatic Malignant Neoplasm in the Brain
RecruitingPhase 1
A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM)
Adult Glioblastoma, High Grade Glioma
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NBM-BMX Capsule and Temozolomide in people with Malignant Neoplasm of Brain, run by Novelwise Pharmaceutical Corporation at 3 sites in Taiwan.
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 17 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 6 May 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 Taiwan. 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 combined 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.
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?
Contact Chia-Chung Hou, Ph.D. (886 2 26559109 ext. 101, alison.hou@novelwisepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency, types, severity, and relationship to NBM-BMX of adverse events (AEs) (time frame: Through study completion, an average of 1 year.). The study lists 2 primary outcomes in all. 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 6 May 2026.