A Rollover Study of NBM-BMX in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma
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)
Novelwise Pharmaceutical Corporation
15 participants
Apr 20, 2026
INTERVENTIONAL
Conditions
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 administered in combination with TMZ.
Eligibility
Inclusion Criteria17
- 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.
- 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.
Exclusion Criteria10
- 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.
- 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.
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Interventions
Each capsule contains 100 mg of the active ingredient.
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.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07569042