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

Recurrent Glioblastoma Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05324501
• Other study ID #: MTX110-102
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: October 19, 2022
• Est. completion date: August 31, 2028

Study information

• Verified date: February 2024
• Source: Biodexa Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: August 31, 2028
• Est. primary completion date: August 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Glioblastoma
• Recurrence
• Recurrent Glioblastoma

Intervention

Drug:
• MTX110
Soluble panobinostat

Device:
• Programmable pump and catheter system
To allow Convection-Enhanced Delivery (CED)

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina
United States	Baptist MD Anderson	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Biodexa Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of MTX110 administered by CED	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.
Primary	To determine the recommended Phase 2 dose (RP2D) of MTX110		Through study completion, an expected average of 28 weeks
Secondary	Overall survival		12 months
Secondary	Progression-free survival	Progression based on mRANO criteria	6 months
Secondary	Best overall response rate	Based on mRANO criteria	6 months