NBM-BMX Administered Orally to Patients With Solid Tumors or Newly Diagnosed Glioblastoma

Exclusion Criteria

• •Arm A (advanced solid tumors)
• •1. Systemic anti-cancer treatment (investigational or approved) within 28 days or 5 half-lives of that drug (whichever is shorter) of the first dose of NBM-BMX.
• •2. Curative radiation therapy within 28 days or palliative RT within 7 days of the first dose of NBM-BMX.
• •3. Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.
• •4. Any of the following within 6 months of the first dose of NBM-BMX: pulmonary embolism events, deep vein thrombosis (DVT) events, myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack.
• •5. 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.
• •6. Known history of human immunodeficiency virus (HIV) infection.
• •7. Men and women of childbearing potential who are unwilling to use highly effective contraceptive methods during the study period.
• •Highly effective contraceptive methods include implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical sterilization or a partner who is sterile.
• •8. Females 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.
• •Arm B (newly diagnosed GBM)
• •1. Prior systemic therapy (including Gliadel wafer implant), immunotherapy, investigational agents, or radiotherapy for glioblastoma.
• •2. Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.
• •3. Corticosteroid use of \> 8 mg/day dexamethasone or equivalent within 5 days before the first dose of NBM-BMX.
• •4. A history of hypersensitivity reaction to temozolomide or dacarbazine.
• •5. Any of the following within 6 months of the first dose of NBM-BMX: pulmonary embolism events, deep vein thrombosis (DVT) events, myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack.
• •6. 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.
• •7. Known history of human immunodeficiency virus (HIV) infection. Note: HIV testing is not required.
• •8. Men and women of childbearing potential who are unwilling to use highly effective contraceptive methods during the study period and for at least 6 months after the final dose of temozolomide.
• •Highly effective contraceptive methods include implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical sterilization or a partner who is sterile.
• •9. Female who are pregnant or breastfeeding.
• •10. 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.