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NG101m Adjuvant Therapy in Glioblastoma Patients
Sponsor: NeuGATE Theranostics
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
Conditions
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.
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.
Locations (1)
Yvonne Kew MD, PLLC
Houston, Texas, United States