NBM-BMX Administered Orally to Patients with Solid Tumors or Newly Diagnosed Glioblastoma
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: Arm A (advanced solid tumors) 1. Having signed and dated the informed consent form. 2. Females or males \> 18 years old. 3. Histologically or cytologically confirmed advanced solid tumors refractory to standard of care therapy, or for which no standard of care therapy is available. 4. 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). 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. 6. Adequate organ function as defined by the following criteria: 1. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 × upper limits of normal (ULN), unless liver metastases present, then ≤ 5 × ULN 2. Total serum bilirubin ≤ 1.5 × ULN unless bilirubin elevation is related to Gilbert's Syndrome for which bilirubin ≤ 3 × ULN 3. Absolute neutrophil count (ANC) ≥ 1,000/μL 4. Platelets ≥ 75,000/μL 5. Hemoglobi