Back to search results

NG101m Adjuvant Therapy for Glioblastoma

This study is testing a new treatment called NG101m for people newly diagnosed with glioblastoma multiforme, a type of brain cancer. You would receive NG101m capsules along with the standard treatments: Intensity-modulated radiation therapy (IMRT) and the drug Temozolomide. Researchers want to see how safe NG101m is by tracking any side effects, and they also want to measure how many participants are still alive after two years. To join, you must be at least 18 years old, have newly diagnosed glioblastoma, and meet certain blood test requirements. The current status of this study is unclear, and it plans to enroll 52 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 52 participants, and all will receive NG101m along with standard therapy.
What's involved
You would receive Intensity-modulated radiation therapy (IMRT) for 3 weeks, along with oral Temozolomide. One month later, you would restart oral Temozolomide for 12 cycles, and take oral NG101m capsules continuously twice daily.
Compensation
Not stated in the trial record.
Follow-up
The study will measure side effects after 1 month and assess overall survival after 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04373785

NG101m Adjuvant Therapy in Glioblastoma Patients

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
NeuGATE Theranostics
~52 participants
Updated 2025-10-21 on ClinicalTrials.gov
What's tested:Intensity-modulated radiation therapyTemozolomideNG101m

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with treatment-emergent adverse events and serious adverse events
Measured over 1 month
+1 more outcome measured

Conditions

Glioblastoma Multiforme

Explore related trials

Glioblastoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Yvonne Kew, MD, PhD · STUDY_DIRECTOR · NeuGATE Theranostics

Who to contact

Thien Tran, PharmD
[email protected]
713-534-1300
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of participants with treatment-emergent adverse events and serious adverse events1 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.