Recurrent High-grade GliomaPhase 1/2NCT05737212
Studying the Safety, Efficacy, and Pharmacokinetic Characteristics of BNCT in Patients With Recurrent High-grade Gliomas
A Phase 1/2 study testing 500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 9Gy-Eq, 500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 11Gy-Eq and 500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 13Gy-Eq in people with Recurrent High-grade Glioma and Recurrent Glioblastoma, run by Dawonmedax Co., Ltd. at 1 site in South Korea.
Trial summary
This is a multi-centered, radiation dose escalation, open, exploratory, Phase 1/2a clinical trial on the safety, efficacy and pharmacokinetic characteristics of BNCT in patients with recurrent high-grade gliomas. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Recurrent High-grade Glioma, Recurrent Glioblastoma, Recurrent Anaplastic Astrocytoma
- What is being tested?
- 500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 9Gy-Eq, 500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 11Gy-Eq and 500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 13Gy-Eq
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Dec 2022to 11 Jun 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An adult at the age 19 or above to under 80 at the time of written consent
- Individual diagnosed with the following according to the WHO classification (2021)
- Astrocytoma, IDH-mutant, WHO grade 3, 4
- Oligodendroglioma, IDH-mutant, and 1p/19q-codeleted, WHO grade 3
- Glioblastoma, IDH wildtype, WHO grade 4
- Anaplastic Astrocytoma, NOS, WHO grade 3
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- Anaplastic Oligoastrocytoma, NOS, WHO grade 3
- Anaplastic Oligodendroglioma, NOS, WHO grade 3
- Glioblastoma, NOS, WHO grade 4
- Individual who received radiation therapy at the standard level (54 to 66 Gy/25 to 35 fractions) or lower
- Individual confirmed to have disease progression* according to the RANO criteria within 4 weeks from the screening visit (*) At least one lesion with contrast enhancement needs to exist on the contrast enhancement MRI. For a subject who shows no lesion with contrast enhancement, functional imaging such as 18F-FET or 18F-FDOPA PET/CT needs to confirm the existence of at least one clear recurrent lesion.
- However, in the event differentiation between recurrence and pseudoprogression is unclear, the subject cannot participate in the screening
- Individual who is able to lie or sit for 30 minutes to 1 hour using the fixing device of the treatment couch
- Individual with no metal implant such as a pacemaker
- Individual with KPS (Karnofsky performance score) ≥ 60
- Individual with an appropriate kidney function, lung function and bone marrow function based on the laboratory test at the screening visit
- Hemoglobin ≥ 10.0 g/dL
- WBC (white blood cell) ≥ 3,500/μL
- Platelets ≥ 100,000/μL
- Serum creatinine ≤ 1.5xULN
- AST (aspartate aminotransferase)/ALT (alanine aminotransferase) ≤ 3xULN
- Individual who receives sufficient explanation on the study, agrees to following the study procedures during the study period, and voluntarily decides to participate in the study and provides a written consent
- [Phase IIa study inclusion criteria]
- Individual histologically diagnosed with glioblastoma
- Individual with at least one measurable observed lesion according to the modified RANO criteria
Who cannot join
- Individual to which a traditional therapy such as reoperation or reirradiation is effectively applicable based on consultation with a brain tumor multidisciplinary committee or consultation among two or more medical departments, including neurosurgery and radiation oncology
- Individual who received cytotoxic anticancer therapy within 4 weeks from the screening visit (including previous interstitial anticancer therapy, local medication, and convection-enhanced delivery)
- Individual who received targeted anticancer therapy (e.g., bevacizumab) within 6 weeks from the screening visit
- Individual who received radiotherapy within 6 months from the screening visit
- Individual who received a radical surgery for high-grade glioma within 4 weeks from the screening visit
- Individual who received biopsy within 1 week from the screening visit
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- Individual confirmed to have a history of the following:
- Interstitial brachytherapy
- Stereotactic radiosurgery
- Reirradiation for a recurrent lesion
- Cancer immunotherapy
- Individual with uncontrollable brain edema* even with the use of corticosteroid (*) Uncontrollable brain edema: Uncontrolled serious headache, vomiting, dyspnea, consciousness disturbance of NCI CTCAE (Ver. 5.0) grade 3 or above. However, for a patient taking corticosteroid, the patient must at least be on a stable dose or dose reduction for 7 days prior to the MRI scan at the screening visit.
- Individual confirmed with meningeal dissemination
- Individual diagnosed with cancer in another site* in the past at the time of the screening visit and whose disease-free period is less than 3 years (*) Patients with the skin basal cell carcinoma and carcinoma in situ of uterine cervix who received radical treatment are excluded
- Individual with hypotonic dehydration or hereditary fructose intolerance
- Individual with current or a history of phenylketonuria
- Individual with serious infection (e.g., sepsis, HIV) in the opinion of the investigator
- Individual who has dysfunction as below or, in the investigator's opinion, who is confirmed to have clinically significant disease (e.g., unstable angina, myocardial infarction) within 6 months from the screening visit:
- Heart disease of Class II or above according to the New York Heart Association Functional Classification
- Chronic obstructive pulmonary disease of moderate or higher severity according to the Chronic obstructive pulmonary disease clinical practice, or Dyspnea of Grade II or above according to the American thoracic society dyspnea scale
- Hepatic dysfunction of Child-Pugh Classification B or C
- Individual with current or a history of hypersensitivity to boron or any component of the study drug
- Individual who received or applied other investigational product or device within 4 weeks from the screening visit
- Individual who has received prior BNCT
- Pregnant woman, breastfeeding woman, or individual who plans pregnancy or who does not agree to using and does not perform a medically reliable contraceptive method during the study period
- Women of childbearing potential*: Use of 'intrauterine device', 'tubal surgery or tubal ligation', 'chemical barrier method (spermicide) + physical barrier method' or 'subcutaneously implanted contraceptive device + physical barrier method' (*) Woman of any potential of pregnancy, except for those who are before their first period, who received surgical sterilization (hysterectomy or bilateral ovariectomy) or who reached menopause (absence of menstrual periods for 12 months without any specific reason)
- Male: Vasectomy or use of 'male condom + use of a medically reliable contraceptive method by the partner'
- Individual not eligible for MRI or PET/CT scan
- Individual the investigator otherwise considers ineligible for participating in the study [At the treatment planning visit, the following exclusion criteria will be checked:]
- Individual not eligible for BNCT implementation according to the treatment plan established with DM-BTPS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-centered, Radiation Dose Escalation, Open, Exploratory, Phase 1/2a Clinical Trial on the Safety, Efficacy and Pharmacokinetic Characteristics of BNCT(Boron Neutron Capture Therapy) in Patients With Recurrent High-grade Gliomas
This is a multi-centered, radiation dose escalation, open, exploratory, Phase 1/2a clinical trial on the safety, efficacy and pharmacokinetic characteristics of BNCT in patients with recurrent high-grade gliomas.
The Phase I clinical study is to explore the adequate radiation dose level of BNCT based on confirmation of the maximum tolerated dose (radiation dose) of BNCT in patients with recurrent high-grade gliomas and characterize the safety, efficacy and pharmacokinetics.
Read more
To evaluate the primary objective of tolerability, subject population with history of exposure to a similar treatment recurrent high-grade glioma who received prior standard radiotherapy will be recruited.
The Phase IIa is to confirm the efficacy and safety after irradiation of radiation dose confirmed in the Phase I clinical study. To evaluate the primary objective of efficacy, subject population with glioblastoma (The 2021 WHO Classification of Tumors of the Central Nervous System, Glioblastoma IDH-wild type, WHO Grade 4) will be recruited.
Read the detailed description
The subject receives the study drug administration and neutron irradiation in the BNCT clinic with all procedures performed under the control by the investigator affiliated to the study site. 500 mg/kg of the study drug is intravenously administered over 3 hours at a constant rate and neutron irradiation starts at 1 hour after the end of the study drug administration according to the previously established neutron irradiation plan.
All patients will be evaluated for response using magnetic resonance imaging (MRI) using RANO and modified RANO criteria.
- Conditions
- Recurrent High-grade Glioma, Recurrent Glioblastoma, Recurrent Anaplastic Astrocytoma, Recurrent Anaplastic Oligodendroglioma
- Being tested
- 500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 9Gy-Eq, 500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 11Gy-Eq, 500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 13Gy-Eq
- Keywords
- Boron neutron capture therapy, boronophenylalanine, neutron capture therapy
- Medical subject headings
- Glioma, Glioblastoma, Astrocytoma, Oligodendroglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 9Gy-EqRadiation
Patients will be infused DMX-101 intravenously at a dose of 500mg/kg/hr over 3 hours. Thereafter, patient will receive neutron irradiation simultaneously for a certain period of time based on his Boronophenylalanine (BPA) concentration in the blood.
500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 11Gy-EqRadiation
Patients will be infused DMX-101 intravenously at a dose of 500mg/kg/hr over 3 hours. Thereafter, patient will receive neutron irradiation simultaneously for a certain period of time based on his Boronophenylalanine (BPA) concentration in the blood.
500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 13Gy-EqRadiation
Patients will be infused DMX-101 intravenously at a dose of 500mg/kg/hr over 3 hours. Thereafter, patient will receive neutron irradiation simultaneously for a certain period of time based on his Boronophenylalanine (BPA) concentration in the blood.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Radiation dose: 9 Gy-Eq
* Investigational product, boronophenylalanine, DMX-101 500mg/kg/3hr
* Investigational Device, DM-BTPS, DM-BNCT - neutron irradiation to reach maximum BNCT dose in brain of 9 Gy-Eq Receives: Radiation: 500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 9Gy-Eq |
| Group 2 | Experimental | Radiation dose: 11 Gy-Eq
* Investigational product, boronophenylalanine, DMX-101 500mg/kg/3hr
* Investigational Device, DM-BTPS, DM-BNCT - neutron irradiation to reach maximum BNCT dose in brain of 11 Gy-Eq Receives: Radiation: 500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 11Gy-Eq |
| Group 3 | Experimental | Radiation dose: 13 Gy-Eq
* Investigational product, boronophenylalanine, DMX-101 500mg/kg/3hr
* Investigational Device, DM-BTPS, DM-BNCT - neutron irradiation to reach maximum BNCT dose in brain of 13Gy-Eq Receives: Radiation: 500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 13Gy-Eq |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: To explore the adequate radiation dose level of BNCT based on confirmation of the maximum tolerated dose of BNCT
To explore the adequate radiation dose level of BNCT based on confirmation of the maximum tolerated dose (radiation dose) of BNCT in patients with recurrent high-grade gliomas
Measured: During 90 days post-BNCT
Phase IIa: Proportion of 6-month PFS evaluated by central imaging according to the modified RANO criteria
Percentage of patients that are free from progressive disease for 6 months per modified RANO criteria
Measured: 6 months
Secondary outcomes (19)
Proportion of 6-month PFS evaluated by central imaging according to the RANO criteria
Percentage of patients that are free from progressive disease for 6 months per RANO criteria
Measured: Up to 6 months
Proportion of 6-month PFS evaluated by the investigator according to the modified RANO criteria
Percentage of patients that are free from progressive disease for 6 months per modified RANO criteria
Measured: Up to 6 months
Median PFS evaluated by central imaging according to the modified RANO criteria
Median duration of progression free survival according to modified RANO criteria
Measured: Up to 6 months
Median PFS evaluated by central imaging according to the RANO criteria
Median duration of progression free survival according to RANO criteria
Measured: Up to 6 months
Median PFS evaluated by the investigator according to the modified RANO criteria
Median duration of progression free survival according to modified RANO criteria
Measured: Up to 6 months
ORR evaluated by central imaging according to the modified RANO criteria
ORR will be defined as the percentage of patients with complete response (CR) or partial response (PR) according to the modified RANO criteria.
Measured: Up to 6 months
ORR evaluated by central imaging according to the RANO criteria
ORR will be defined as the percentage of patients with complete response (CR) or partial response (PR) according to the RANO criteria.
Measured: Up to 6 months
ORR evaluated by the investigator according to the modified RANO criteria
ORR will be defined as the percentage of patients with complete response (CR) or partial response (PR) according to the modified RANO criteria.
Measured: Up to 6 months
Median OS
Median duration of overall survival for patients that are alive
Measured: Up to 2 years
Proportion of 1-year OS
Percentage of patients that are alive for 1 year
Measured: Up to 2 years
Pharmacokinetic parameters(AUClast) of borono-phenylalanine in subjects with recurrent high-grade glioma
The analysis is conducted using the Noncompartmental Analysis Method, and the results are summarized for each group in terms of descriptive statistics including the mean, standard deviation, minimum, median, and maximum values.
Measured: Based on whole blood sample up to 48 hours after the end of infusion
Pharmacokinetic parameters(AUCinf) of borono-phenylalanine in subjects with recurrent high-grade glioma
The analysis is conducted using the Noncompartmental Analysis Method, and the results are summarized for each group in terms of descriptive statistics including the mean, standard deviation, minimum, median, and maximum values.
Measured: Based on whole blood sample up to 48 hours after the end of infusion
Pharmacokinetic parameters(Cmax) of borono-phenylalanine in subjects with recurrent high-grade glioma
The analysis is conducted using the Noncompartmental Analysis Method, and the results are summarized for each group in terms of descriptive statistics including the mean, standard deviation, minimum, median, and maximum values.
Measured: Based on whole blood sample up to 48 hours after the end of infusion
Pharmacokinetic parameters(Tmax) of borono-phenylalanine in subjects with recurrent high-grade glioma
The analysis is conducted using the Noncompartmental Analysis Method, and the results are summarized for each group in terms of descriptive statistics including the mean, standard deviation, minimum, median, and maximum values.
Measured: sampling up to 48 hours after the end of infusion
Pharmacokinetic parameters(CL) of borono-phenylalanine in subjects with recurrent high-grade glioma
The analysis is conducted using the Noncompartmental Analysis Method, and the results are summarized for each group in terms of descriptive statistics including the mean, standard deviation, minimum, median, and maximum values.
Measured: Based on whole blood sample up to 48 hours after the end of infusion
Pharmacokinetic parameters(Vz) of borono-phenylalanine in subjects with recurrent high-grade glioma
The analysis is conducted using the Noncompartmental Analysis Method, and the results are summarized for each group in terms of descriptive statistics including the mean, standard deviation, minimum, median, and maximum values.
Measured: Based on whole blood sample up to 48 hours after the end of infusion
Pharmacokinetic parameters(Vss) of borono-phenylalanine in subjects with recurrent high-grade glioma
The analysis is conducted using the Noncompartmental Analysis Method, and the results are summarized for each group in terms of descriptive statistics including the mean, standard deviation, minimum, median, and maximum values.
Measured: Based on whole blood sample up to 48 hours after the end of infusion
Pharmacokinetic parameters(t1/2β) of borono-phenylalanine in subjects with recurrent high-grade glioma
The analysis is conducted using the Noncompartmental Analysis Method, and the results are summarized for each group in terms of descriptive statistics including the mean, standard deviation, minimum, median, and maximum values.
Measured: Based on whole blood sample up to 48 hours after the end of infusion
Pharmacokinetic parameters(MRT) of borono-phenylalanine in subjects with recurrent high-grade glioma
The analysis is conducted using the Noncompartmental Analysis Method, and the results are summarized for each group in terms of descriptive statistics including the mean, standard deviation, minimum, median, and maximum values.
Measured: Based on whole blood sample up to 48 hours after the end of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start5 Dec 2022
- Primary completion11 Jun 2024
- Study completion11 Jun 2024
Why it stopped: The Phase 1 clinical trial was completed, and the study was stopped to initiate a Phase 2 trial with a revised protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent High-grade GliomaStudies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- In the Phase I clinical study, the 3+3 dose escalation design is applied to evaluate the dose limiting toxicity (DLT) and 3 study subjects are enrolled to each group (Group 1, Group 2, Group 3). Depending on whether or not DLT occurs, 3 subjects at minimum to 18 subjects at maximum are enrolled. However, in the event a subject assigned a subject number withdraws from the study before starting BNCT or within 90 days from starting BNCT for reasons other than safety, up to 3 additional subjects can be enrolled for each dose group, resulting in 27 subjects at maximum allowed for enrollment for the Phase I clinical study. In the Phase IIa clinical study, up to 12 subjects are enrolled. However, subjects who are included in a group that has received the radiation dose confirmed as the maximum tolerated dose (MTD) in the Phase 1 clinical study AND satisfy all inclusion/exclusion criteria of the Phase IIa are included in the number of subjects of Phase IIa.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dawonmedax Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Woo Kim, M.D., Ph.D., Study director, Dawonmedax Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737212
- Sponsor's protocol ID
- DM-BNCT-P001
- Status last verified
- Feb 2023
- First submitted
- 9 Feb 2023
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centered, Radiation Dose Escalation, Open, Exploratory, Phase 1/2a Clinical Trial on the Safety, Efficacy and Pharmacokinetic Characteristics of BNCT(Boron Neutron Capture Therapy) in Patients With Recurrent High-grade Gliomas
- ClinicalTrials.gov ID
- NCT05737212
- Acronym / sponsor ID
- DM-BNCT-P001
- Conditions
- Recurrent High-grade Glioma, Recurrent Glioblastoma, Recurrent Anaplastic Astrocytoma, Recurrent Anaplastic Oligodendroglioma
- Keywords
- Boron neutron capture therapy, boronophenylalanine, neutron capture therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Phase 1 clinical trial was completed, and the study was stopped to initiate a Phase 2 trial with a revised protocol.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Dawonmedax Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 11 Jun 2024 (actual)
- Study completion
- 11 Jun 2024 (actual)
- First posted
- 21 Feb 2023 (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.
This is a multi-centered, radiation dose escalation, open, exploratory, Phase 1/2a clinical trial on the safety, efficacy and pharmacokinetic characteristics of BNCT in patients with recurrent high-grade gliomas.
The Phase I clinical study is to explore the adequate radiation dose level of BNCT based on confirmation of the maximum tolerated dose (radiation dose) of BNCT in patients with recurrent high-grade gliomas and characterize the safety, efficacy and pharmacokinetics.
To evaluate the primary objective of tolerability, subject population with history of exposure to a similar treatment recurrent high-grade glioma who received prior standard radiotherapy will be recruited.
The Phase IIa is to confirm the efficacy and safety after irradiation of radiation dose confirmed in the Phase I clinical study. To evaluate the primary objective of efficacy, subject population with glioblastoma (The 2021 WHO Classification of Tumors of the Central Nervous System, Glioblastoma IDH-wild type, WHO Grade 4) will be recruited.
Detailed description
The subject receives the study drug administration and neutron irradiation in the BNCT clinic with all procedures performed under the control by the investigator affiliated to the study site. 500 mg/kg of the study drug is intravenously administered over 3 hours at a constant rate and neutron irradiation starts at 1 hour after the end of the study drug administration according to the previously established neutron irradiation plan.
All patients will be evaluated for response using magnetic resonance imaging (MRI) using RANO and modified RANO criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- In the Phase I clinical study, the 3+3 dose escalation design is applied to evaluate the dose limiting toxicity (DLT) and 3 study subjects are enrolled to each group (Group 1, Group 2, Group 3). Depending on whether or not DLT occurs, 3 subjects at minimum to 18 subjects at maximum are enrolled. However, in the event a subject assigned a subject number withdraws from the study before starting BNCT or within 90 days from starting BNCT for reasons other than safety, up to 3 additional subjects can be enrolled for each dose group, resulting in 27 subjects at maximum allowed for enrollment for the Phase I clinical study. In the Phase IIa clinical study, up to 12 subjects are enrolled. However, subjects who are included in a group that has received the radiation dose confirmed as the maximum tolerated dose (MTD) in the Phase 1 clinical study AND satisfy all inclusion/exclusion criteria of the Phase IIa are included in the number of subjects of Phase IIa.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Radiation: 500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 9Gy-EqRadiation dose: 9 Gy-Eq * Investigational product, boronophenylalanine, DMX-101 500mg/kg/3hr * Investigational Device, DM-BTPS, DM-BNCT - neutron irradiation to reach maximum BNCT dose in brain of 9 Gy-Eq |
| Group 2 | Experimental | Radiation: 500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 11Gy-EqRadiation dose: 11 Gy-Eq * Investigational product, boronophenylalanine, DMX-101 500mg/kg/3hr * Investigational Device, DM-BTPS, DM-BNCT - neutron irradiation to reach maximum BNCT dose in brain of 11 Gy-Eq |
| Group 3 | Experimental | Radiation: 500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 13Gy-EqRadiation dose: 13 Gy-Eq * Investigational product, boronophenylalanine, DMX-101 500mg/kg/3hr * Investigational Device, DM-BTPS, DM-BNCT - neutron irradiation to reach maximum BNCT dose in brain of 13Gy-Eq |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- An adult at the age 19 or above to under 80 at the time of written consent
- Individual diagnosed with the following according to the WHO classification (2021)
- Individual who received radiation therapy at the standard level (54 to 66 Gy/25 to 35 fractions) or lower
- Individual confirmed to have disease progression* according to the RANO criteria within 4 weeks from the screening visit (*) At least one lesion with contrast enhancement needs to exist on the contrast enhancement MRI. For a subject who shows no lesion with contrast enhancement, functional imaging such as 18F-FET or 18F-FDOPA PET/CT needs to confirm the existence of at least one clear recurrent lesion.
- However, in the event differentiation between recurrence and pseudoprogression is unclear, the subject cannot participate in the screening
Key exclusion criteria (30 listed)
- Individual to which a traditional therapy such as reoperation or reirradiation is effectively applicable based on consultation with a brain tumor multidisciplinary committee or consultation among two or more medical departments, including neurosurgery and radiation oncology
- Individual who received cytotoxic anticancer therapy within 4 weeks from the screening visit (including previous interstitial anticancer therapy, local medication, and convection-enhanced delivery)
- Individual who received targeted anticancer therapy (e.g., bevacizumab) within 6 weeks from the screening visit
- Individual who received radiotherapy within 6 months from the screening visit
- Individual who received a radical surgery for high-grade glioma within 4 weeks from the screening visit
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 |
|---|---|---|
| 500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 9Gy-EqPatients will be infused DMX-101 intravenously at a dose of 500mg/kg/hr over 3 hours. Thereafter, patient will receive neutron irradiation simultaneously for a certain period of time based on his Boronophenylalanine (BPA) concentration in the blood. | Radiation | Group 1 |
| 500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 11Gy-EqPatients will be infused DMX-101 intravenously at a dose of 500mg/kg/hr over 3 hours. Thereafter, patient will receive neutron irradiation simultaneously for a certain period of time based on his Boronophenylalanine (BPA) concentration in the blood. | Radiation | Group 2 |
| 500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 13Gy-EqPatients will be infused DMX-101 intravenously at a dose of 500mg/kg/hr over 3 hours. Thereafter, patient will receive neutron irradiation simultaneously for a certain period of time based on his Boronophenylalanine (BPA) concentration in the blood. | Radiation | Group 3 |
Primary outcome
Phase I: To explore the adequate radiation dose level of BNCT based on confirmation of the maximum tolerated dose of BNCT
Time frame: During 90 days post-BNCT
To explore the adequate radiation dose level of BNCT based on confirmation of the maximum tolerated dose (radiation dose) of BNCT in patients with recurrent high-grade gliomas
Phase IIa: Proportion of 6-month PFS evaluated by central imaging according to the modified RANO criteria
Time frame: 6 months
Percentage of patients that are free from progressive disease for 6 months per modified RANO criteria
19 secondary outcomes
Proportion of 6-month PFS evaluated by central imaging according to the RANO criteria
Time frame: Up to 6 months
Proportion of 6-month PFS evaluated by the investigator according to the modified RANO criteria
Time frame: Up to 6 months
Median PFS evaluated by central imaging according to the modified RANO criteria
Time frame: Up to 6 months
Median PFS evaluated by central imaging according to the RANO criteria
Time frame: Up to 6 months
Median PFS evaluated by the investigator according to the modified RANO criteria
Time frame: Up to 6 months
ORR evaluated by central imaging according to the modified RANO criteria
Time frame: Up to 6 months
ORR evaluated by central imaging according to the RANO criteria
Time frame: Up to 6 months
ORR evaluated by the investigator according to the modified RANO criteria
Time frame: Up to 6 months
Median OS
Time frame: Up to 2 years
Proportion of 1-year OS
Time frame: Up to 2 years
Pharmacokinetic parameters(AUClast) of borono-phenylalanine in subjects with recurrent high-grade glioma
Time frame: Based on whole blood sample up to 48 hours after the end of infusion
Pharmacokinetic parameters(AUCinf) of borono-phenylalanine in subjects with recurrent high-grade glioma
Time frame: Based on whole blood sample up to 48 hours after the end of infusion
Pharmacokinetic parameters(Cmax) of borono-phenylalanine in subjects with recurrent high-grade glioma
Time frame: Based on whole blood sample up to 48 hours after the end of infusion
Pharmacokinetic parameters(Tmax) of borono-phenylalanine in subjects with recurrent high-grade glioma
Time frame: sampling up to 48 hours after the end of infusion
Pharmacokinetic parameters(CL) of borono-phenylalanine in subjects with recurrent high-grade glioma
Time frame: Based on whole blood sample up to 48 hours after the end of infusion
Pharmacokinetic parameters(Vz) of borono-phenylalanine in subjects with recurrent high-grade glioma
Time frame: Based on whole blood sample up to 48 hours after the end of infusion
Pharmacokinetic parameters(Vss) of borono-phenylalanine in subjects with recurrent high-grade glioma
Time frame: Based on whole blood sample up to 48 hours after the end of infusion
Pharmacokinetic parameters(t1/2β) of borono-phenylalanine in subjects with recurrent high-grade glioma
Time frame: Based on whole blood sample up to 48 hours after the end of infusion
Pharmacokinetic parameters(MRT) of borono-phenylalanine in subjects with recurrent high-grade glioma
Time frame: Based on whole blood sample up to 48 hours after the end of infusion
Results and safety
The study was stopped early (reason given: The Phase 1 clinical trial was completed, and the study was stopped to initiate a Phase 2 trial with a revised protocol.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: No
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Recurrent Pulmonary Osteosarcoma, Recurrent High-grade Glioma
Not yet recruitingPhase 1
IL-8 Receptor-modified CD70 CAR T Cell Therapy in CD70+ Newly Diagnosed and Recurrent Pediatric High-grade Glioma (pHGG) and Newly Diagnosed Diffuse Intrinsic Pontine Glioma (ndDIPG)
High-grade Glioma, Diffuse Intrinsic Pontine Glioma
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. This study is not recruiting at the moment.
Woo Kim, M.D., Ph.D. study director
Dawonmedax Co., Ltd.
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 500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 9Gy-Eq, 500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 11Gy-Eq and 500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 13Gy-Eq in people with Recurrent High-grade Glioma and Recurrent Glioblastoma, run by Dawonmedax Co., Ltd. at 1 site in South Korea.
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 25 inclusion and 30 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: stopped early, as of the sponsor's last update on 21 Feb 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 South Korea. 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?
The study was stopped early (reason given: The Phase 1 clinical trial was completed, and the study was stopped to initiate a Phase 2 trial with a revised protocol.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: To explore the adequate radiation dose level of BNCT based on confirmation of the maximum tolerated dose of BNCT (time frame: During 90 days post-BNCT). 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 Feb 2025.