NG101m Adjuvant Therapy in Glioblastoma Patients

Part of paid clinical trials in Houston, Texas.

Sponsor
NeuGATE Theranostics
Study ID
NCT04373785
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Glioblastoma Multiforme

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.
  • NG101m — DRUG
    Oral NG101m capsule continuously twice daily.

Study Details

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.

Key Dates

Start date
Jan 1, 2027
Status verified
Oct 2025
Primary completion
Jul 30, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
52 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NG101m and standard treatment
    Concomittant therapy: Radiation therapy, oral temozolomide, and oral NG101m Adjuvant therapy: Oral temozolomide and oral NG101m

Primary Outcome Measure

Number of participants with treatment-emergent adverse events and serious adverse events [ Time Frame: 1 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yvonne Kew MD, PLLCHoustonTexas77030
Thien Tran, Pharm.D.
[email protected]
713-534-1300
Yvonne Kew, MD, PhD (PRINCIPAL_INVESTIGATOR)

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Yvonne Kew MD, PLLC· Houston, TX

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