A Rollover Study of NBM-BMX in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma

May 1, 2026 updated by: Novelwise Pharmaceutical Corporation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Not yet recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Contact:
          • Ann-Shung Lieu, M.D.
          • Phone Number: +886 7 3121101
      • Taichung, Taiwan, 407
        • Not yet recruiting
        • Taichung Veterans General Hospital
        • Contact:
          • Wen-Yu Cheng, M.D.
          • Phone Number: +886 4 23592525
      • Taoyuan City, Taiwan, 333
        • Recruiting
        • Linkou Chang-Gung Memorial Hospital
        • Contact:
          • Kuo-Chen Wei, M.D.
          • Phone Number: +886 3 3281200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Participants must meet all of the following criteria to be eligible for the study:

  1. 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.
  2. Histologically confirmed glioblastoma.
  3. Can enroll into this rollover study within 35 days after completing the last dose of NBM-BMX in the parent study.
  4. Have signed and dated the informed consent form.
  5. Karnofsky performance status (KPS) ≥ 60 at enrollment in this study.

  6. Adequate organ functions as defined by the following criteria:

    1. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 × upper limit of normal (ULN)
    2. Total serum bilirubin ≤ 1.5 × ULN unless bilirubin elevation is related to Gilbert's Syndrome for which bilirubin ≤ 3 × ULN
    3. Absolute neutrophil count (ANC) ≥ 1,000/µL
    4. Platelets ≥ 75,000/µL
    5. Hemoglobin ≥ 8.0 g/dL
    6. Non-indexed estimated glomerular filtration rate (eGFR) ≥ 50 mL/min
  7. Women of childbearing potential must have a negative pregnancy test performed within 14 days before the first dose of this study.

  8. 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.

  9. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.

Exclusion Criteria:

Participants with any of the following will be excluded from the study:

  1. Currently receive or plan to receive anti-cancer treatments other than the study drugs including Gliadel wafer implant or tumor treating fields (TTFields).
  2. Permanently discontinued from the parent study due to unacceptable toxicity, non-compliance with study procedures, withdrawal of consent, or any other reason.
  3. 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.
  4. QTcF > 480 msec
  5. Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.
  6. Have known hypersensitivity reaction to temozolomide, dacarbazine or NBM-BMX.
  7. Have difficulty swallowing (including those require nasogastric tube) or with impaired absorption of oral medications.
  8. Female who are pregnant or breastfeeding.
  9. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Combination therapy in glioblastoma
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.
Drug: NBM-BMX Capsule
Each capsule contains 100 mg of the active ingredient.
Drug: Temozolomide
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.
Other Names:
  • TMZ

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year.
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.
Through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novelwise Pharmaceutical Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NBM-BMX-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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