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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 therapy being developed by Biodexa Pharmaceuticals plc (BDRX) for diffuse intrinsic pontine glioma. It combines MTX110 with gadolinium and is delivered directly into the tumor via convection-enhanced delivery. It is in Phase 1 clinical development.
Infusate with MTX110 and gadolinium is being studied for the treatment of diffuse intrinsic pontine glioma, a rare and aggressive pediatric brain tumor. It is an investigational therapy and has not been approved for any indication. The Phase 1 trial enrolled 9 patients with newly diagnosed diffuse midline gliomas.
Infusate with MTX110 and gadolinium is being developed by Biodexa Pharmaceuticals plc, which trades under the ticker BDRX. The company is the sponsor of the clinical program evaluating this investigational therapy for diffuse intrinsic pontine glioma and other diffuse midline gliomas.
Infusate with MTX110 and gadolinium is in Phase 1 clinical development. The single Phase 1 trial, NCT04264143, has been completed. It was an uncontrolled, non-randomized study that enrolled 9 patients. The therapy remains investigational and has not been approved by the FDA.
Infusate with MTX110 and gadolinium has been evaluated in one Phase 1 clinical trial, NCT04264143, titled CED of MTX110 Newly Diagnosed Diffuse Midline Gliomas. The trial was completed and enrolled 9 patients in the United States. It studied patients with diffuse intrinsic pontine glioma and other diffuse midline gliomas.