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
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.
Exclusion Criteria:
Weekly dosing of MTX110 via CED until progression/ unacceptable toxicity.
Drug: MTX110 · Device: Programmable pump and catheter system
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
Soluble panobinostat
To allow Convection-Enhanced Delivery (CED)
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.
To determine the recommended Phase 2 dose (RP2D) of MTX110
Time frame: Through study completion, an expected average of 28 weeks
Overall survival
Time frame: 12 months
Progression-free survival
Progression based on mRANO criteria
Time frame: 6 months
Best overall response rate
Based on mRANO criteria
Time frame: 6 months
This study is terminated, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Biodexa Pharmaceuticals