Glioblastoma MultiformePhase 1/2NCT04373785
NG101m Adjuvant Therapy in Glioblastoma Patients
A Phase 1/2 study testing Intensity-modulated radiation therapy, Temozolomide and NG101m in people with Glioblastoma Multiforme, run by NeuGATE Theranostics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Intensity-modulated radiation therapy, Temozolomide and NG101m
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 31 Dec 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Yvonne Kew MD, PLLC
Houston, Texas, 77030
Thien Tran, Pharm.D., 713-534-1300, Thien@DrKew.com
Yvonne Kew, MD, PhD
About this study
Official title: A Multi-Center Pilot/Phase I and Phase II Clinical Trial of NG101m Adjuvant Therapy in Newly Diagnosed Glioblastoma Patients
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.
Read the 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
- Being tested
- Intensity-modulated radiation therapy, Temozolomide, NG101m
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity-modulated radiation therapyRadiation
Also called 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.
TemozolomideDrug
Also called Temodar
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.
NG101mDrug
Also called NG101m regimen
Oral NG101m capsule continuously twice daily.
| Study group | Role | What they receive |
|---|---|---|
| NG101m and standard treatment | Experimental | Concomittant therapy:
Radiation therapy, oral temozolomide, and oral NG101m
Adjuvant therapy:
Oral temozolomide and oral NG101m Receives: Radiation: Intensity-modulated radiation therapy; Drug: Temozolomide; Drug: NG101m |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events and serious adverse events
Safety and tolerability of NG101m as adjuvant therapy to chemoradiation therapy
Measured: 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.
Measured: 24 months
Secondary outcomes (2)
Progression-free survival (PFS)
Assess the duration of PFS
Measured: 24 months
Response assessment in neuro-oncology (RANO) criteria
Radiological response to adjuvant NG101m therapy
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start1 Jan 2027 (estimated)
- Primary completion30 Jul 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Radiation: Radiotherapy Drug: Temozolomide Drug: NG101m
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuGATE Theranostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yvonne Kew, MD, PhD, Study director, NeuGATE Theranostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373785
- Sponsor's protocol ID
- NG101m
- Status last verified
- Oct 2025
- First submitted
- 30 Apr 2020
- Last updated
- 21 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Pilot/Phase I and Phase II Clinical Trial of NG101m Adjuvant Therapy in Newly Diagnosed Glioblastoma Patients
- ClinicalTrials.gov ID
- NCT04373785
- Acronym / sponsor ID
- NG101m
- Conditions
- Glioblastoma Multiforme
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- NeuGATE TheranosticsIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Jul 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Radiation: Radiotherapy Drug: Temozolomide Drug: NG101m
| Arm | Type | Receives |
|---|---|---|
| NG101m and standard treatment | Experimental | Radiation: Intensity-modulated radiation therapy, Drug: Temozolomide, Drug: NG101mConcomittant therapy: Radiation therapy, oral temozolomide, and oral NG101m Adjuvant therapy: Oral temozolomide and oral NG101m |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensity-modulated radiation therapyAlso: radiation therapyIntensity-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. | Radiation | NG101m and standard treatment |
| TemozolomideAlso: TemodarOral 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 and standard treatment |
| NG101mAlso: NG101m regimenOral NG101m capsule continuously twice daily. | Drug | NG101m and standard treatment |
Primary outcome
Number of participants with treatment-emergent adverse events and serious adverse events
Time frame: 1 month
Safety and tolerability of NG101m as adjuvant therapy to chemoradiation therapy
Efficacy of NG101m adjuvant chemoradiation therapy assessed by measuring 2-year overall survival rate.
Time frame: 24 months
Efficacy of NG101m adjuvant therapy will be assessed by measuring 2-year overall survival rate.
2 secondary outcomes
Progression-free survival (PFS)
Time frame: 24 months
Response assessment in neuro-oncology (RANO) criteria
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yvonne Kew, MD, PhD study director
NeuGATE Theranostics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intensity-modulated radiation therapy, Temozolomide and NG101m in people with Glioblastoma Multiforme, run by NeuGATE Theranostics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thien Tran, PharmD (713-534-1300, TTran@NeuGATE.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-emergent adverse events and serious adverse events (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025.