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

Primary Purpose

Recurrent Glioblastoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MTX110
Programmable pump and catheter system
Sponsored by
Biodexa Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 nitrosoureas
  • 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 (growing) disease (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);

Sites / Locations

  • Baptist MD AndersonRecruiting
  • Duke University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort A: MTX-110

Cohort B: MTX-110 with optional catheter repositioning

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Safety of MTX110 administered by CED
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

Secondary Outcome Measures

Overall survival
Progression-free survival
Progression based on mRANO criteria
Best overall response rate
Based on mRANO criteria

Full Information

First Posted
March 28, 2022
Last Updated
October 18, 2023
Sponsor
Biodexa Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05324501
Brief Title
A Study of Intra-tumoral Administered MTX110 in Patients With Recurrent Glioblastoma
Acronym
MAGIC-G1
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2022 (Actual)
Primary Completion Date
August 31, 2028 (Anticipated)
Study Completion Date
August 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biodexa Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Glioblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Two cohort 3+3 design. Between 4-18 patients per cohort.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A: MTX-110
Arm Type
Experimental
Arm Description
Weekly dosing of MTX110 via CED until progression/ unacceptable toxicity.
Arm Title
Cohort B: MTX-110 with optional catheter repositioning
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
MTX110
Intervention Description
Soluble panobinostat
Intervention Type
Device
Intervention Name(s)
Programmable pump and catheter system
Intervention Description
To allow Convection-Enhanced Delivery (CED)
Primary Outcome Measure Information:
Title
Safety of MTX110 administered by CED
Description
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.
Title
To determine the recommended Phase 2 dose (RP2D) of MTX110
Time Frame
Through study completion, an expected average of 28 weeks
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
12 months
Title
Progression-free survival
Description
Progression based on mRANO criteria
Time Frame
6 months
Title
Best overall response rate
Description
Based on mRANO criteria
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fiona Forsyth
Phone
+44(0)2920 480 180
Email
fiona.forsyth@biodexapharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nicola Tuckwell
Phone
+44(0)2920 480 180
Email
nicola.tuckwell@biodexapharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dmitry Zamoryakhin
Organizational Affiliation
Biodexa Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Baptist MD Anderson
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darlene Brabant
Email
darlene.brabant@bmcjax.com
First Name & Middle Initial & Last Name & Degree
Aubrey Coyle
Email
aubrey.coyle@bmcjax.com
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Central Team
Email
dukebrain1@dm.duke.edu

12. IPD Sharing Statement

Learn more about this trial

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

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