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

NCT ID: NCT05324501

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-19
• Study Completion Date: 2024-09-10

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.

Conditions

Recurrent Glioblastoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort A: MTX-110

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

Group Type: EXPERIMENTAL

MTX110

Intervention Type: DRUG

Soluble panobinostat

Programmable pump and catheter system

Intervention Type: DEVICE

To allow Convection-Enhanced Delivery (CED)

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.

Group Type: EXPERIMENTAL

MTX110

Intervention Type: DRUG

Soluble panobinostat

Programmable pump and catheter system

Intervention Type: DEVICE

To allow Convection-Enhanced Delivery (CED)

Interventions

MTX110

Soluble panobinostat

Intervention Type: DRUG

Programmable pump and catheter system

To allow Convection-Enhanced Delivery (CED)

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biodexa Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary Shangold

Role: STUDY_DIRECTOR

Biodexa Pharmaceuticals

Locations

Baptist MD Anderson

Jacksonville, Florida, United States

Duke University Hospital

Durham, North Carolina, United States

Countries

United States

Other Identifiers

MTX110-102

Identifier Type: -

Identifier Source: org_study_id