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

Prior treatment

• Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.
• Have difficulty swallowing (including those require nasogastric tube) or with impaired absorption of oral medications.

Other illness

• Currently receive or plan to receive anti-cancer treatments other than the study drugs including Gliadel wafer implant or tumor treating fields (TTFields).
• 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.
• Have known hypersensitivity reaction to temozolomide, dacarbazine or NBM-BMX.

Lab values

• 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.

Other

• Participants with any of the following will be excluded from the study:
• Permanently discontinued from the parent study due to unacceptable toxicity, non-compliance with study procedures, withdrawal of consent, or any other reason.
• QTcF \> 480 msec
• Female who are pregnant or breastfeeding.

• 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.