drugset / Trial / NCT06012695

NBM-BMX Administered Orally to Patients With Solid Tumors or Newly Diagnosed Glioblastoma

NCT06012695

Phase 1/2 Recruiting 79 enrolled Novelwise Pharmaceutical Corporation
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-08-11
Primary completion
2028-05-30
Completion
2029-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject NBM-BMX Small molecule 100 mg Oral
Background Temozolomide Small molecule 75 mg/m2 Oral
Background Temozolomide Small molecule 150 mg/m2 Oral
Background Temozolomide Small molecule 200 mg/m2 Oral

Indications