RecruitingPhase 1Phase 2NCT06012695

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

A Phase Ib/II, Open-label Study of NBM-BMX as Monotherapy or in Combination With Radiotherapy and Temozolomide in Subjects With Solid Tumors or Newly Diagnosed Glioblastoma


Sponsor

Novelwise Pharmaceutical Corporation

Enrollment

79 participants

Start Date

Aug 11, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing an oral drug called NBM-BMX for two groups: people with advanced solid tumors that no longer respond to standard treatments, and people who have been newly diagnosed with glioblastoma (an aggressive brain tumor). The study is in an early phase to assess safety and determine the right dose. **You may be eligible if...** - You are over 18 - Group A: You have advanced solid tumors that have stopped responding to standard therapies, or no standard therapy is available - Group B: You have newly diagnosed glioblastoma (brain tumor) - You have at least one measurable tumor on imaging - You are in reasonably good health (ECOG 0–2) - Your liver, kidney, and blood function are within acceptable limits - Your heart rhythm is normal (QTcF ≤480ms) **You may NOT be eligible if...** - Your organ function is significantly impaired - You recently received blood transfusions to meet eligibility criteria - You are unable to comply with study visit requirements - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNBM-BMX Capsule

Each capsule contains 100 mg of the active ingredient.

DRUGTemozolomide

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.

RADIATIONStandard radiotherapy

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


Locations(4)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Taiwan

Linkou Chang-Gung Memorial Hospital

Taoyuan City, Taiwan

View Full Details on ClinicalTrials.gov

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NCT06012695


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