NG101m Adjuvant Therapy in Glioblastoma Patients

NCT04373785 · tracked via the Priya Life Science USA tracker

Sponsor

NeuGATE Theranostics

Phase

Phase 1/2

Started

2027-01-01

Last updated

2025-10-21

Condition(s) studied

Glioblastoma Multiforme

Investigational drug(s) / intervention(s)

Intensity-modulated radiation therapyTemozolomide →NG101m

Intensity-modulated radiation therapy: Intensity-modulated radiation therapy (IMRT) in daily fractions of 2.67 Gy given 5 days per week for 3 weeks, for a total of 40.05 Gy.

Temozolomide: Oral temozolomide (75 mg/m2), given 5 days per week, for 3 weeks during radiotherapy. 1 month after the discontinuation of radiotherapy, oral temozolomide is restarted at 150 to 200 mg/m2 for 5 days during each 28-day cycle for 12 cycles.

NG101m: Oral NG101m capsule continuously twice daily.

Study summary

The purpose of this clinical trial is to evaluate the addition of NG101m adjuvant therapy to standard of care treatment of glioblastoma multiforme. All subjects will receive NG101m capsules along with the standard treatment of temozolomide and radiation.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Male or female subjects ≥ 18 years of age * Must be newly diagnosed with GBM * Primary treatment must consist of a chemoradiation therapy (CRT) regimen * Hemoglobin \> 9 g/dL * White blood count 3,600 - 11,000/mm3 * Absolute neutrophil count (ANC) ≥ 1,500/mm3 * Absolute lymphocyte count (ALC) ≥ 1,000/mm3 * Platelet count 100,000/mm3 * BUN ≤ 1.5 times upper limit of normal * Creatinine clearance rate \> 40 mL/min * ALT ≤ 3 times upper limit of normal * AST ≤ 3 times upper limit of normal * Alkaline phosphatase ≤ 3 times upper limit of normal * Total bilirubin ≤ 2.0 mg/dL * Karnofsky Performance Status ≥ 70 * Must not be on any other alternative therapies * Not pregnant Exclusion Criteria: * Known hypersensitivity to meloxicam, famotidine, and/or caffeine or any of their derivatives or components * Known allergy to vitamin A, vitamin D3, and/or L-citrulline * Pregnant women * Breastfeeding women * Corticosteroid therapy that cannot be tapered down to a dose of 1 - 2 mg/day of dexamethasone or its equivalent * History of immunodeficiency diseases or autoimmune diseases * History of peptic ulcer disease or gastrointestinal perforation

Primary outcome measure(s)

Number of participants with treatment-emergent adverse events and serious adverse events — 1 month
Safety and tolerability of NG101m as adjuvant therapy to chemoradiation therapy
Efficacy of NG101m adjuvant chemoradiation therapy assessed by measuring 2-year overall survival rate. — 24 months
Efficacy of NG101m adjuvant therapy will be assessed by measuring 2-year overall survival rate.

Trial sites (1)

Facility	City	Region	Status
Yvonne Kew MD, PLLC	Houston	Texas

Other trials for the same condition

A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM Recruiting

A Study of NanO2™ Combined With Radiation and Temozolomide in Patients With Newly Diagnosed GBM Active, not recruiting

Study of DSP-0390 in Patients With Recurrent High-Grade Glioma Active, not recruiting

A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB) Active, not recruiting

A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects With Recurrent Glioblastoma Multiforme (GBM) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04373785 on ClinicalTrials.gov ↗ ← All trials in the USA