Actively Recruiting
NBM-BMX Administered Orally to Patients With Solid Tumors or Newly Diagnosed Glioblastoma
Led by Novelwise Pharmaceutical Corporation · Updated on 2026-04-29
79
Participants Needed
4
Research Sites
320 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NBM-BMX Administered Orally to Patients With Solid Tumors or Newly Diagnosed Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Age over 18 years
- For Arm A: Histologically or cytologically confirmed advanced solid tumors not responding to standard treatment or lacking standard options
- For Arm A: Measurable or evaluable disease per RECIST v1.1 or RANO criteria (for CNS tumors)
- For Arm A: ECOG performance status 0 to 2
- For Arm A: Adequate organ function including liver enzymes, bilirubin, blood counts, and kidney function meeting specified limits without transfusion
- For Arm A: QTcF less than or equal to 480 msec
- For Arm A: Willingness and ability to follow study visits, treatments, and tests
- For Arm B: Newly diagnosed, histologically confirmed glioblastoma (non-resectable, partially resected, or resected)
- For Arm B: Karnofsky performance status of 60 or higher at screening and before starting combination therapy
- For Arm B: Measurable or evaluable disease per RANO criteria
- For Arm B: Adequate organ function including liver enzymes, bilirubin, blood counts, and kidney function meeting specified limits without transfusion
- For Arm B: QTcF less than or equal to 480 msec
- For Arm B: Willingness and ability to follow study visits, treatments, and tests
You will not qualify if you...
- For Arm A: Systemic anti-cancer treatment within 28 days or 5 half-lives before first NBM-BMX dose
- For Arm A: Curative radiation therapy within 28 days or palliative radiation therapy within 7 days before first NBM-BMX dose
- For Arm A: Current use of strong CYP2C8 inhibitors or inducers
- For Arm A: Serious cardiovascular or thromboembolic events within 6 months before first NBM-BMX dose
- For Arm A: Positive hepatitis B or C test unless viral levels are undetectable
- For Arm A: Known HIV infection
- For Arm A: Unwillingness to use highly effective contraception if of childbearing potential
- For Arm A: Pregnant or breastfeeding women
- For Arm A: Other severe medical or psychiatric conditions posing excess risk
- For Arm B: Prior systemic therapy, immunotherapy, investigational agents, or radiotherapy for glioblastoma
- For Arm B: Current use of strong CYP2C8 inhibitors or inducers
- For Arm B: Use of corticosteroids over 8 mg/day dexamethasone equivalent within 5 days before first NBM-BMX dose
- For Arm B: Hypersensitivity to temozolomide or dacarbazine
- For Arm B: Serious cardiovascular or thromboembolic events within 6 months before first NBM-BMX dose
- For Arm B: Positive hepatitis B or C test unless viral levels are undetectable
- For Arm B: Known HIV infection (testing not required)
- For Arm B: Unwillingness to use highly effective contraception during study and for 6 months after last temozolomide dose if of childbearing potential
- For Arm B: Pregnant or breastfeeding women
- For Arm B: Other severe medical or psychiatric conditions posing excess risk
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807
Not Yet Recruiting
2
Taichung Veterans General Hospital
Taichung, Taiwan, 407
Actively Recruiting
3
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Taiwan, 112
Actively Recruiting
4
Linkou Chang-Gung Memorial Hospital
Taoyuan City, Taiwan, 333
Actively Recruiting
Research Team
C
Chia-Chung Hou, Ph.D.
CONTACT
K
Karis Chiang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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