MedTrace Logo

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

NCT06012695 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2026-04-29

No results posted yet for this study

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.

Conditions

  • Malignant Neoplasm
  • Malignant Neoplasm of Brain

Interventions

DRUG

NBM-BMX Capsule

Each capsule contains 100 mg of the active ingredient.

DRUG

Temozolomide

TMZ will be administered orally at a 75 mg/m2 dose daily during concomitant therapy. In the maintenance period, days 1-5 of each cycle will be administered 150-200 mg/m2.

RADIATION

Standard radiotherapy

A total dose of 60 Gy will be administered in 6 weeks.

Sponsors & Collaborators

  • Novelwise Pharmaceutical Corporation

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-11
Primary Completion
2028-05-30
Completion
2029-09-30
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06012695 on ClinicalTrials.gov