Recurrent GlioblastomaPhase 1MAGIC-G1NCT05324501
A Study of Intra-tumoral Administered MTX110 in Patients With Recurrent Glioblastoma
A Phase 1 study testing MTX110 and Programmable pump and catheter system in people with Recurrent Glioblastoma, run by Biodexa Pharmaceuticals at 2 sites in United States.
Trial summary
A study designed to assess the safety of MTX110 in patients suffering with recurrent glioblastoma. MTX110 will be administered directly to the site of the tumour via a catheter which is inserted during a surgical procedure at the beginning of the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Glioblastoma
- What is being tested?
- MTX110 and Programmable pump and catheter system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Oct 2022to 10 Sep 2024
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recurrent glioblastoma.
- Patients must be healthy enough to tolerate surgery and general anesthesia.
- Estimated life expectancy of greater than 3 months.
Who cannot join
- Patients scheduled to undergo or are undergoing re-irradiation for the recurrent tumour.
- Patients with a history of glioblastoma treatment with carmustine or Gliadel® wafers.
- Patients who cannot undergo MRI.
- Patients may not have received chemotherapy or bevacizumab ≤ 4 weeks, or metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide (1 week) prior to starting the study drug.
- Patients may not have received treatment with tumor treating fields ≤ 1 week prior to starting the study drug.
- Patients may not be less than 12 weeks from completion of radiation therapy for the primary tumor.
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- Patients with neoplastic lesions in the brainstem, cerebellum, or spinal cord; radiological evidence of active; multifocal disease; extensive subependymal disease (tumor touching subependymal space is allowed); tumor crossing the midline or leptomeningeal disease.
- Posterior fossa location of the tumor, regardless of its morphology.
- Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin (treatment with tamoxifen or aromatase inhibitors or other hormonal therapy that may be indicated in prevention of prior cancer disease recurrence, are not considered current active treatment).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Hospital
Durham, North Carolina, 27710
Baptist MD Anderson
Jacksonville, Florida, 32207
About this study
Official title: Phase I Open Label Ascending Dose Study to Assess the Feasibility and Safety of Intermittent Infusions of MTX110 Administered by Convection-Enhanced Delivery (CED) in Patients With Recurrent Glioblastoma (rGBM) (MAGIC-G1)
A study designed to assess the safety of MTX110 in patients suffering with recurrent glioblastoma. MTX110 will be administered directly to the site of the tumour via a catheter which is inserted during a surgical procedure at the beginning of the study.
Read the detailed description
A two cohort, ascending dose study of intra-tumoral MTX110 in patients with recurrent glioblastoma. With the aim to assess the safety and also the recommended phase 2 dose of MTX110.
The patient will undergo a surgical procedure to insert a programmable pump and catheter system to allow administration of MTX110 directly to the tumour using Convection Enhanced Delivery (CED).
Cohort A patients will receive one of three potential dose levels of MTX110 as a weekly infusion in order to establish recommended phase 2 dose. This will be based on an accelerated dose titration/3+3 design.
Cohort B patients will follow the 3+3 study design with the starting concentration established in Cohort A. They too will receive MTX110 as a weekly infusion and may undergo catheter repositioning and continued treatment following progression.
- Conditions
- Recurrent Glioblastoma
- Being tested
- MTX110, Programmable pump and catheter system
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTX110Drug
Soluble panobinostat
Programmable pump and catheter systemDevice
To allow Convection-Enhanced Delivery (CED)
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: MTX-110 | Experimental | Weekly dosing of MTX110 via CED until progression/ unacceptable toxicity. Receives: Drug: MTX110; Device: Programmable pump and catheter system |
| Cohort B: MTX-110 with optional catheter repositioning | Experimental | Weekly dosing of MTX110 via CED until progression. At progression, optional catheter repositioning may occur, followed by continued weekly dosing of MTX110 until next progression/ unacceptable toxicity. Receives: Drug: MTX110; Device: Programmable pump and catheter system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of MTX110 administered by CED
The frequency and nature of adverse events, serious adverse events and dose limiting toxicities (DLTs).
Measured: Through study completion, an expected average of 28 weeks. DLT period 28 days from first dose.
To determine the recommended Phase 2 dose (RP2D) of MTX110
Measured: Through study completion, an expected average of 28 weeks
Secondary outcomes (3)
Overall survival
Measured: 12 months
Progression-free survival
Progression based on mRANO criteria
Measured: 6 months
Best overall response rate
Based on mRANO criteria
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start19 Oct 2022
- Primary completion10 Sep 2024
- Study completion10 Sep 2024
Why it stopped: Strategic decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent GlioblastomaStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Two cohort 3+3 design. Between 4-18 patients per cohort.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biodexa Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Shangold, Study director, Biodexa Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324501
- Sponsor's protocol ID
- MTX110-102
- Acronym
- MAGIC-G1
- Status last verified
- Feb 2025
- First submitted
- 28 Mar 2022
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Open Label Ascending Dose Study to Assess the Feasibility and Safety of Intermittent Infusions of MTX110 Administered by Convection-Enhanced Delivery (CED) in Patients With Recurrent Glioblastoma (rGBM) (MAGIC-G1)
- ClinicalTrials.gov ID
- NCT05324501
- Acronym / sponsor ID
- MAGIC-G1 / MTX110-102
- Conditions
- Recurrent Glioblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic decision
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Biodexa PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 12 Apr 2022 (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.
A study designed to assess the safety of MTX110 in patients suffering with recurrent glioblastoma. MTX110 will be administered directly to the site of the tumour via a catheter which is inserted during a surgical procedure at the beginning of the study.
Detailed description
A two cohort, ascending dose study of intra-tumoral MTX110 in patients with recurrent glioblastoma. With the aim to assess the safety and also the recommended phase 2 dose of MTX110.
The patient will undergo a surgical procedure to insert a programmable pump and catheter system to allow administration of MTX110 directly to the tumour using Convection Enhanced Delivery (CED).
Cohort A patients will receive one of three potential dose levels of MTX110 as a weekly infusion in order to establish recommended phase 2 dose. This will be based on an accelerated dose titration/3+3 design.
Cohort B patients will follow the 3+3 study design with the starting concentration established in Cohort A. They too will receive MTX110 as a weekly infusion and may undergo catheter repositioning and continued treatment following progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two cohort 3+3 design. Between 4-18 patients per cohort.
| Arm | Type | Receives |
|---|---|---|
| Cohort A: MTX-110 | Experimental | Drug: MTX110, Device: Programmable pump and catheter systemWeekly dosing of MTX110 via CED until progression/ unacceptable toxicity. |
| Cohort B: MTX-110 with optional catheter repositioning | Experimental | Drug: MTX110, Device: Programmable pump and catheter systemWeekly dosing of MTX110 via CED until progression. At progression, optional catheter repositioning may occur, followed by continued weekly dosing of MTX110 until next progression/ unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recurrent glioblastoma.
- Patients must be healthy enough to tolerate surgery and general anesthesia.
- Estimated life expectancy of greater than 3 months.
Key exclusion criteria (9 listed)
- Patients scheduled to undergo or are undergoing re-irradiation for the recurrent tumour.
- Patients with a history of glioblastoma treatment with carmustine or Gliadel® wafers.
- Patients who cannot undergo MRI.
- Patients may not have received chemotherapy or bevacizumab ≤ 4 weeks, or metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide (1 week) prior to starting the study drug.
- Patients may not have received treatment with tumor treating fields ≤ 1 week prior to starting the study drug.
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 |
|---|---|---|
| MTX110Soluble panobinostat | Drug | Cohort A: MTX-110, Cohort B: MTX-110 with optional catheter repositioning |
| Programmable pump and catheter systemTo allow Convection-Enhanced Delivery (CED) | Device | Cohort A: MTX-110, Cohort B: MTX-110 with optional catheter repositioning |
Primary outcome
Safety of MTX110 administered by CED
Time frame: Through study completion, an expected average of 28 weeks. DLT period 28 days from first dose.
The frequency and nature of adverse events, serious adverse events and dose limiting toxicities (DLTs).
To determine the recommended Phase 2 dose (RP2D) of MTX110
Time frame: Through study completion, an expected average of 28 weeks
3 secondary outcomes
Overall survival
Time frame: 12 months
Progression-free survival
Time frame: 6 months
Best overall response rate
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Strategic decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
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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. This study is not recruiting at the moment.
Gary Shangold study director
Biodexa Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MTX110 and Programmable pump and catheter system in people with Recurrent Glioblastoma, run by Biodexa Pharmaceuticals at 2 sites 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 3 inclusion and 9 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 10 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 2 sites 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 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.
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: Strategic decision). 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?
Safety of MTX110 administered by CED (time frame: Through study completion, an expected average of 28 weeks. DLT period 28 days from first dose.). 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 10 Feb 2025.