NBM-BMX is an orally available new chemical entity to inhibit HDAC8 activity specifically, being developed as a potential anti-cancer therapeutic by NatureWise. The objectives of this study are to evaluate the safety, pharmacokinetics, and preliminary efficacy of NBM-BMX as monotherapy in subjects with advanced solid tumors (Arm A) or in combination with the standard of care treatment (i.e., concomitant RT/TMZ followed by adjuvant TMZ) in subjects with newly diagnosed glioblastoma (Arm B).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Patients will initially receive NBM-BMX orally once a day at 100 mg per day.
National Cheng Kung University Hospital
Tainan, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Dose limiting toxicity (DLT) of NBM-BMX [Safety and Tolerability]
Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
Time frame: up to 28 days
Maximum tolerated dose (MTD) of NBM-BMX [Safety and Tolerability]
The MTD will be defined as the dose level at which at most one of six patients experiences a DLT after 28 days of treatment have occurred, with the next higher dose having at least 2/3 or 2/6 patients experiencing a DLT.
Time frame: up to 28 days
Preliminary assessment of anti-tumor activity by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) [Efficacy]
Time frame: at least 8 weeks
AUC(0-last) of NBM-BMX [Pharmacokinetics]
AUC(0-last): area under the plasma concentration versus time curve to the time of the last measurable concentration
Time frame: Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days)
Cmax of NBM-BMX [Pharmacokinetics]
Cmax: maximum plasma concentration
Time frame: Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days)
Tmax of NBM-BMX [Pharmacokinetics]
Tmax: time to maximum plasma concentration
Time frame: Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days)
T(1/2) of NBM-BMX [Pharmacokinetics]
T(1/2): terminal elimination half-life
Time frame: Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days)
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