OncoMatch/Clinical Trials/NCT06012695
NBM-BMX Administered Orally to Patients with Solid Tumors or Newly Diagnosed Glioblastoma
Is NCT06012695 recruiting? Yes, currently enrolling (May 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
Cancer type
Tumor Agnostic
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.
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