OncoMatch/Clinical Trials/NCT06012695
NBM-BMX Administered Orally to Patients with Solid Tumors or Newly Diagnosed Glioblastoma
Is NCT06012695 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including NBM-BMX Capsule and Temozolomide for malignant neoplasm.
Treatment: NBM-BMX Capsule · Temozolomide — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Tumor Agnostic
Glioblastoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic anti-cancer treatment
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.
Cannot have received: radiation therapy
Curative radiation therapy within 28 days or palliative RT within 7 days of the first dose of NBM-BMX.
Cannot have received: systemic therapy (Gliadel wafer implant)
Prior systemic therapy (including Gliadel wafer implant), immunotherapy, investigational agents, or radiotherapy for glioblastoma.
Cannot have received: immunotherapy
Prior systemic therapy (including Gliadel wafer implant), immunotherapy, investigational agents, or radiotherapy for glioblastoma.
Cannot have received: investigational agent
Prior systemic therapy (including Gliadel wafer implant), immunotherapy, investigational agents, or radiotherapy for glioblastoma.
Cannot have received: radiation therapy
Prior systemic therapy (including Gliadel wafer implant), immunotherapy, investigational agents, or radiotherapy for glioblastoma.
Lab requirements
Blood counts
ANC ≥ 1,000/μL (Arm A), ≥ 1,500/μL (Arm B); platelets ≥ 75,000/μL (Arm A), ≥ 100,000/μL (Arm B); hemoglobin ≥ 8.0 g/dL
Kidney function
eGFR ≥ 50 mL/min/1.73 m2 × BSA (Arm A); eGFR ≥ 60 mL/min/1.73 m2 × BSA (Arm B)
Liver function
AST and ALT ≤ 3 × ULN, unless liver metastases present, then ≤ 5 × ULN; total bilirubin ≤ 1.5 × ULN unless Gilbert's Syndrome, then ≤ 3 × ULN
Cardiac function
QTcF ≤ 480 msec
Adequate organ function as defined by the following criteria: AST and ALT ≤ 3 × ULN, unless liver metastases present, then ≤ 5 × ULN; total bilirubin ≤ 1.5 × ULN unless Gilbert's Syndrome, then ≤ 3 × ULN; ANC ≥ 1,000/μL (Arm A), ≥ 1,500/μL (Arm B); platelets ≥ 75,000/μL (Arm A), ≥ 100,000/μL (Arm B); hemoglobin ≥ 8.0 g/dL; eGFR ≥ 50 mL/min/1.73 m2 × BSA (Arm A), ≥ 60 mL/min/1.73 m2 × BSA (Arm B); QTcF ≤ 480 msec
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06012695 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic anti-cancer treatment, radiation therapy, systemic therapy disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages