Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04264143 | CED of MTX110 Newly Diagnosed Diffuse Midline Gliomas | PHASE1 | COMPLETED | 9 | — | — | Mar 10, 2020 | Nov 22, 2023 | Dec 18, 2023 | 1 | United States |
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 ...