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NOT YET RECRUITING
NCT04373785
PHASE1/PHASE2

NG101m Adjuvant Therapy in Glioblastoma Patients

Sponsor: NeuGATE Theranostics

View on ClinicalTrials.gov

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.

Official title: A Multi-Center Pilot/Phase I and Phase II Clinical Trial of NG101m Adjuvant Therapy in Newly Diagnosed Glioblastoma Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2027-01-01

Completion Date

2030-12-31

Last Updated

2025-10-21

Healthy Volunteers

No

Interventions

RADIATION

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.

DRUG

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.

DRUG

NG101m

Oral NG101m capsule continuously twice daily.

Locations (1)

Yvonne Kew MD, PLLC

Houston, Texas, United States