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Infusate with MTX110 and gadolinium · 1 trial · 3 indications
Safety of repeated convection-enhanced delivery (CED) of MTX110 will be reported by summarizing the incidence rate of adverse events observed or reported. Adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
The MTD will be determined based on the number of dose limiting toxicities (DLT) observed in each of the titrated doses.
| Arm | Type | Description |
|---|---|---|
| MTX110 and CED | EXPERIMENTAL | All patients enrolled in the study will receive infusion of MTX110 and Gadolinium delivered by the CED delivery system directly into the tumor over 9-11 days. |
| Name | Type | Description |
|---|---|---|
| Infusate with MTX110 and gadolinium | DRUG | Pulses 1 and 2 will be prepared with 30, 60 or 90 uM concentration of MTX110. The infusate consists of gadolinium and MTX110 (30, 60, or 90 uM) at approximately 1:100 ratio. |
| Convection-Enhanced Delivery (CED) | DEVICE | CED is the method by which the drug are delivered to the brain under controlled pressure to the brain by targeted micro-catheters. |
Inclusion Criteria: * Aged more than 3 years up to the 18th birthday * Radiological diagnosis of DIPG with tumor confined to the region of the pons or * thalami without cystic changes or hematoma obstructing the planned catheter trajectories * Radiological diagnosis of thalamic gliomas confined to ...
Infusate with MTX110 and gadolinium is an investigational small molecule being studied for the treatment of Diffuse Intrinsic Pontine Glioma (DIPG), a type of brain tumor. It is administered as an infusate and is currently in Phase 1 clinical development.
Infusate with MTX110 and gadolinium is being developed by Biodexa Pharmaceuticals plc, a biopharmaceutical company. The company's stock is traded under the ticker symbol BDRX.
Infusate with MTX110 and gadolinium is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed.
Infusate with MTX110 and gadolinium has been studied in one clinical trial, identified as NCT04264143. This Phase 1 trial, titled 'CED of MTX110 Newly Diagnosed Diffuse Midline Gliomas,' was completed and enrolled 9 participants with conditions including Diffuse Intrinsic Pontine Glioma.
Yes, Infusate with MTX110 and gadolinium contains MTX110 as the active pharmaceutical ingredient, combined with gadolinium. The drug is referred to as an infusate because it is administered via convection-enhanced delivery directly into the tumor.