Tests NBM-BMX capsules in people with solid tumors or new glioblastoma

Trial details

Who runs it

Novelwise Pharmaceutical Corporation

Trial code

NCT06012695

Record updated

29 April 2026

Original description

NBM-BMX is an orally available new chemical entity to inhibit histone deacetylases 8 (HDAC8) activity specifically, being developed as a potential anti-cancer therapeutic by NatureWise. This study aims to evaluate the safety, pharmacokinetics, and preliminary efficacy of NBM-BMX as monotherapy in subjects with advanced solid tumors or combination with the standard of care treatment in subjects with newly diagnosed glioblastoma.Read full original descriptionShow less

A Phase Ib/II, Open-label Study of NBM-BMX as Monotherapy or in Combination With Radiotherapy and Temozolomide in Subjects With Solid Tumors or Newly Diagnosed Glioblastoma

NBM-BMX is an orally available new chemical entity to inhibit histone deacetylases 8 (HDAC8) activity specifically, being developed as a potential anti-cancer therapeutic by NatureWise. This study aims to evaluate the safety, pharmacokinetics, and preliminary efficacy of NBM-BMX as monotherapy in subjects with advanced solid tumors or combination with the standard of care treatment in subjects with newly diagnosed glioblastoma.

Inclusion: Arm A (advanced solid tumors); Having signed and dated the informed consent form; Females or males > 18 years old; Histologically or cytologically confirmed advanced solid tumors refractory to standard of care therapy, or for which no standard of care therapy is available; Disease that is measurable or evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Response Assessment in Neuro-Oncology (RANO) criteria (for CNS tumors); Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2; Adequate organ function as defined by the following criteria:; Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 × upper limits of normal (ULN), unless liver metastases present, then ≤ 5 × 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/1.73 m2 × BSA (m2)/1.73; Transfusion is not allowed to meet entry criteria; QTcF ≤ 480 msec; Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures; Arm B (newly diagnosed GBM); Having signed and dated the informed consent form; Females or males > 18 years old; Newly diagnosed, histologically confirmed glioblastoma, non-resectable, partially resected or resected; Karnofsky performance status (KPS) ≥ 60 at screening and before the initiation (Day 1) of concomitant therapy; Disease that is measurable or evaluable as defined by Response Assessment in Neuro-Oncology (RANO) criteria; Adequate organ function as defined by the following criteria:; Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 × upper limit of normal (ULN), unless liver metastases present, then ≤ 5 × 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) ≥ 1,500/μL; Platelets ≥ 100,000/μL; Hemoglobin ≥ 8.0 g/dL; Non-indexed estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2 × BSA (m2)/1.73; Transfusion is not allowed to meet entry criteria; QTcF ≤ 480 msec; Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.

Exclusion: Curative radiation therapy within 28 days or palliative RT within 7 days of the first dose of NBM-BMX; Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8; 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; Prior systemic therapy (including Gliadel wafer implant), immunotherapy, investigational agents, or radiotherapy for glioblastoma; Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8; Corticosteroid use of > 8 mg/day dexamethasone or equivalent within 5 days before the first dose of NBM-BMX; 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; 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; 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; 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; Known history of human immunodeficiency virus (HIV) infection; A history of hypersensitivity reaction to temozolomide or dacarbazine; 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; 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; Known history of human immunodeficiency virus (HIV) infection. Note: HIV testing is not required; 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); 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 A (advanced solid tumors); Females who are pregnant or breastfeeding; Female who are pregnant or breastfeeding.

ClinicalTrials.gov NCT06012695