A Study of Intra-tumoral Administered MTX110 in Patients With Recurrent Glioblastoma (MAGIC-G1)

February 6, 2025 updated by: Biodexa Pharmaceuticals

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist MD Anderson
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Recurrent glioblastoma.
  • Patients must be healthy enough to tolerate surgery and general anesthesia.
  • Estimated life expectancy of greater than 3 months.

Exclusion Criteria:

  • 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.
  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A: MTX-110
Weekly dosing of MTX110 via CED until progression/ unacceptable toxicity.
Drug: MTX110
Soluble panobinostat
Device: Programmable pump and catheter system
To allow Convection-Enhanced Delivery (CED)
Experimental: Cohort B: MTX-110 with optional catheter repositioning
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.
Drug: MTX110
Soluble panobinostat
Device: Programmable pump and catheter system
To allow Convection-Enhanced Delivery (CED)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
Time Frame: Through study completion, an expected average of 28 weeks
Through study completion, an expected average of 28 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 12 months
12 months
Progression-free survival
Time Frame: 6 months
Progression based on mRANO criteria
6 months
Best overall response rate
Time Frame: 6 months
Based on mRANO criteria
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biodexa Pharmaceuticals

Investigators

  • Study Director: Gary Shangold, Biodexa Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2022

Primary Completion (Actual)

September 10, 2024

Study Completion (Actual)

September 10, 2024

Study Registration Dates

First Submitted

March 28, 2022

First Submitted That Met QC Criteria

April 5, 2022

First Posted (Actual)

April 12, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTX110-102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Recurrent Glioblastoma

Clinical Trials on MTX110

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe