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Glioma

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Panobinostat

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.

MTX110

To allow Convection-Enhanced Delivery (CED)

Programmable pump and catheter system

Dmitry Zamoryakhin

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.

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.

Two cohort 3+3 design. Between 4-18 patients per cohort.

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

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)

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Intra-tumoral Administered MTX110 in Patients With Recurrent Glioblastoma	NCT05324501	Recurrent Gliob...	MTX110 Programmable pu...	18 Years -	Biodexa Pharmaceuticals
A Study of Intra-tumoral Administered MTX110 in Patients With Recurrent Glioblastoma	NCT05324501	Recurrent Gliob...	MTX110 Programmable pu...	18 Years -	Biodexa Pharmaceuticals

Spots Global Cancer Trial Database for programmable pump and catheter system