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.
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.
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
Single group
NBM-BMX Capsule
DrugEach capsule contains 100 mg of the active ingredient.
Temozolomide
DrugTemodal 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.
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.
Progression-free survival (PFS) and overall survival (OS)
To assess the preliminary long-term efficacy of the combination therapy.
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