NG101m Adjuvant Therapy in Glioblastoma Patients

NCT04373785 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: NG101m
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (2)

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

  Safety and tolerability of NG101m as adjuvant therapy to chemoradiation therapy

  1 month

• Efficacy of NG101m adjuvant chemoradiation therapy assessed by measuring 2-year overall survival rate.

  Efficacy of NG101m adjuvant therapy will be assessed by measuring 2-year overall survival rate.

  24 months

Secondary Outcomes (2)

• Progression-free survival (PFS)

  24 months

• Response assessment in neuro-oncology (RANO) criteria

  24 months

Other Outcomes (1)

• Identify and quantify immune/effector cells

  24 months

Study Arms (1)

NG101m and standard treatment

EXPERIMENTAL

Concomittant therapy: Radiation therapy, oral temozolomide, and oral NG101m Adjuvant therapy: Oral temozolomide and oral NG101m

Radiation: Intensity-modulated radiation therapy; Drug: Temozolomide; Drug: NG101m

Interventions

Intensity-modulated radiation therapy RADIATION

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.

Also known as: radiation therapy

NG101m and standard treatment

Temozolomide DRUG

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.

Also known as: Temodar

NG101m and standard treatment

NG101m DRUG

Oral NG101m capsule continuously twice daily.

Also known as: NG101m regimen

NG101m and standard treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NeuGATE Theranostics: lead

Study Sites (1)

Yvonne Kew MD, PLLC

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Radiotherapy, Intensity-Modulated; Radiotherapy; Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Therapeutics; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yvonne Kew, MD, PhD

  NeuGATE Theranostics

  STUDY DIRECTOR

Central Study Contacts

Thien Tran, PharmD

CONTACT

713-534-1300; TTran@NeuGATE.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Radiation: Radiotherapy Drug: Temozolomide Drug: NG101m

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 4, 2020
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): July 30, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)