A Rollover Study of NBM-BMX in Combination With Temozolomide in Patients With Newly Diagnosed Gli… (NCT07569042) | Clinical Trial Compass
RecruitingPhase 1/2
A Rollover Study of NBM-BMX in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma
Taiwan15 participantsStarted 2026-04-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.
What they're measuring
1
Frequency, types, severity, and relationship to NBM-BMX of adverse events (AEs)
Timeframe: Through study completion, an average of 1 year.
2
Progression-free survival (PFS) and overall survival (OS)
Timeframe: Through study completion, an average of 1 year.