NBM-BMX Administered Orally to Patients With Solid Tumors or Newly Diagnosed Glioblastoma (NCT06012695) | Clinical Trial Compass
RecruitingPhase 1/2
NBM-BMX Administered Orally to Patients With Solid Tumors or Newly Diagnosed Glioblastoma
Taiwan79 participantsStarted 2023-08-11
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.
✕. 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.
What they're measuring
1
[Arm A, Phase Ib] Frequency of dose-limiting toxicity (DLT) at each dose level
Timeframe: up to 28 days
2
[Arm B, Phase Ib] Frequency of dose-limiting toxicity (DLT) at each dose level
. 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.
✕. Men and women of childbearing potential who are unwilling to use highly effective contraceptive methods during the study period.