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TerminatedNCT05324501MAGIC-G1Updated Feb 10, 2025

A Study of Intra-tumoral Administered MTX110 in Patients With Recurrent Glioblastoma

A Phase 1 interventional study of MTX110 and Programmable pump and catheter system in Recurrent Glioblastoma, sponsored by Biodexa Pharmaceuticals. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-10.

Sponsored by Biodexa Pharmaceuticals · Phase 1, Interventional, and Treatment

Why this study was terminated
Strategic decision
Phase
Phase 1
Study type
Interventional
Enrollment
4
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Recurrent Glioblastoma
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    Cohort A: MTX-110

    Weekly dosing of MTX110 via CED until progression/ unacceptable toxicity.

    Drug: MTX110 · Device: Programmable pump and catheter system

  • 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 · Device: Programmable pump and catheter system

Interventions

  • DrugMTX110

    Soluble panobinostat

  • DeviceProgrammable pump and catheter system

    To allow Convection-Enhanced Delivery (CED)

05

What researchers measure

Primary outcomes

  1. Safety of MTX110 administered by CED

    The frequency and nature of adverse events, serious adverse events and dose limiting toxicities (DLTs).

    Time frame: Through study completion, an expected average of 28 weeks. DLT period 28 days from first dose.

  2. To determine the recommended Phase 2 dose (RP2D) of MTX110

    Time frame: Through study completion, an expected average of 28 weeks

Secondary outcomes

  1. Overall survival

    Time frame: 12 months

  2. Progression-free survival

    Progression based on mRANO criteria

    Time frame: 6 months

  3. Best overall response rate

    Based on mRANO criteria

    Time frame: 6 months

06

Study locations

2 sites
  • Baptist MD Anderson
    Jacksonville, Florida 32207, United States
  • Duke University Hospital
    Durham, North Carolina 27710, United States
07

Registry details

Key details

Study ID
NCT05324501
Lead sponsor
Biodexa Pharmaceuticals
Responsible party
Sponsor
First posted
Apr 12, 2022
Start date
Oct 19, 2022
Primary completion
Sep 10, 2024
Completion
Sep 10, 2024
Last update
Feb 10, 2025

Study contacts

Gary Shangold
study director · Biodexa Pharmaceuticals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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