NG101m Adjuvant Therapy in Glioblastoma Patients

NCT ID: NCT04373785

Last Updated: 2025-10-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2027-01-01
• Study Completion Date: 2030-12-31

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.

Detailed Description

Glioblastoma multiforme (GBM) is the most lethal form of malignant brain cancer, with about 12,000 new cases diagnosed each in the the United States. The current standard treatment consists of maximal, safe resection, followed by radiation therapy of 60 Gray (Gy) with concomitant oral temozolomide (TMZ) for 6 weeks, then continue with six cycles of high-dose temozolomide. The median survival rate for newly diagnosed GBM patients is 14.6 months with a 2-year overall survival (OS) rate of 27.2%. This clinical trial evaluates the 2-year OS of oral NG101m as an adjuvant therapy to chemoradiotherapy in newly diagnosed GBM subjects.

Conditions

Glioblastoma Multiforme

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NG101m and standard treatment

Concomittant therapy:

Radiation therapy, oral temozolomide, and oral NG101m

Adjuvant therapy:

Oral temozolomide and oral NG101m

Group Type: EXPERIMENTAL

Intensity-modulated radiation therapy

Intervention Type: 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.

Temozolomide

Intervention Type: 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.

NG101m

Intervention Type: DRUG

Oral NG101m capsule continuously twice daily.

Interventions

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.

Intervention Type: RADIATION

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.

Intervention Type: DRUG

NG101m

Oral NG101m capsule continuously twice daily.

Intervention Type: DRUG

Other Intervention Names

radiation therapy; Temodar; NG101m regimen

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NeuGATE Theranostics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yvonne Kew, MD, PhD

Role: STUDY_DIRECTOR

NeuGATE Theranostics

Locations

Yvonne Kew MD, PLLC

Houston, Texas, United States

Countries

United States

Central Contacts

Thien Tran, PharmD

Role: CONTACT

TTran@NeuGATE.org

713-534-1300

Facility Contacts

Thien Tran, Pharm.D.

Role: primary

Thien@DrKew.com

713-534-1300

Other Identifiers

NG101m

Identifier Type: -

Identifier Source: org_study_id