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Virus Therapy
Intra-tumoral MTX110 for Glioblastoma (MAGIC-G1 Trial)
Phase 1
Waitlist Available
Research Sponsored by Biodexa Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Recurrent glioblastoma
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
MAGIC-G1 Trial Summary
This trialstudies a new drug to treat glioblastoma, by putting it directly into the tumor. Surgery is needed to start the trial.
Who is the study for?
This trial is for patients with recurrent glioblastoma who are healthy enough for surgery and general anesthesia, have a life expectancy over 3 months, and haven't had certain recent treatments. Excluded are those with specific brain lesions, prior nitrosoureas treatment, inability to undergo MRI, or active treatment for another cancer.Check my eligibility
What is being tested?
The study tests the safety of MTX110 when directly administered into the tumor site using a catheter system inserted surgically. The focus is on individuals whose glioblastoma has returned after previous treatments.See study design
What are the potential side effects?
Potential side effects may include complications from surgery or catheter placement, reactions to MTX110 at the tumor site such as inflammation or infection, and general side effects like fatigue or nausea.
MAGIC-G1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My brain cancer has come back after treatment.
MAGIC-G1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety of MTX110 administered by CED
To determine the recommended Phase 2 dose (RP2D) of MTX110
Secondary outcome measures
Best overall response rate
Overall survival
Progression-free survival
MAGIC-G1 Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort B: MTX-110 with optional catheter repositioningExperimental Treatment2 Interventions
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.
Group II: Cohort A: MTX-110Experimental Treatment2 Interventions
Weekly dosing of MTX110 via CED until progression/ unacceptable toxicity.
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Who is running the clinical trial?
Biodexa PharmaceuticalsLead Sponsor
Midatech LtdLead Sponsor
Dmitry ZamoryakhinStudy DirectorBiodexa Pharmaceuticals
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had chemotherapy or certain cancer drugs in the last 4 weeks.I am scheduled for or currently receiving a second round of radiation for a returning tumor.You are unable to have an MRI scan.I have been treated for glioblastoma with nitrosoureas.You are expected to live for at least 3 more months.It has been more than 12 weeks since I completed radiation therapy for my primary tumor.My tumor is located in the back part of my brain.I am not currently receiving treatment for any cancer other than possibly skin cancer or cervical carcinoma in situ.My cancer has not spread to my brainstem, cerebellum, or spinal cord and is not actively growing in these areas.My brain cancer has come back after treatment.I am healthy enough to undergo surgery and anesthesia.I haven't had tumor treating fields therapy in the last week.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A: MTX-110
- Group 2: Cohort B: MTX-110 with optional catheter repositioning
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the combination of MTX-110 and lomustine considered secure for patients?
"Our team at Power ranked the safety of MTX-110 in combination with lomustine a 1, as it is currently going through Phase 1 trials which provide limited information on its efficacy and security."
Answered by AI
Is this experimental protocol currently recruiting participants?
"According to clinicaltrials.gov, the recruitment process for this medical trial is ongoing. This experiment was launched on October 19th 2022 and has been refreshed with new information most recently on October 24th 2022."
Answered by AI
What is the current enrollment count for this experiment?
"Affirmative. According to the information located on clinicaltrials.gov, this examination is presently recruiting individuals who meet its criteria. The trial was first published on October 19th 2022 and last updated five days later. 8 participants need to be recruited from two sites in total."
Answered by AI
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