Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
D2C7-IT · 1 trial · 1 indication
An unacceptable adverse event includes any Grade 3 or any Grade 4 toxicity that is not reversible within 2 weeks, any life-threatening event, or any treatment-related death. Also included are any grade 2 or higher serious autoimmune toxicities, particularly those affecting vital organs (e.g. cardiac, renal, CNS) if it occurs within 2 weeks of any protocol treatment.
| Arm | Type | Description |
|---|---|---|
| D2C7-IT (6920 ng/mL) + Atezolizumab | EXPERIMENTAL | Single D2C7-IT convection-enhanced delivery (CED) infusion (6920 ng/mL) plus atezolizumab (1200 mg) intravenous (IV) infusions every three weeks for up to two years |
| D2C7-IT (4613.2 ng/mL) + Atezolizumab | EXPERIMENTAL | Single D2C7-IT convection-enhanced delivery (CED) infusion (4613.2 ng/mL) plus atezolizumab (1200 mg) intravenous (IV) infusions every three weeks for up to two years |
| Name | Type | Description |
|---|---|---|
| D2C7-IT (6920 ng/mL via convection-enhanced delivery) | DRUG | dual-specific mAB |
| Atezolizumab (1200 mg every three weeks) | DRUG | programmed cell death ligand 1 (PD-L1) blocking antibody |
| D2C7-IT (4613.2 ng/mL via convection-enhanced delivery) | DRUG | dual-specific mAB |
Inclusion Criteria: * Patients must have a recurrent supratentorial WHO grade IV malignant glioma based on imaging studies * Prior histopathology confirmed recurrent supratentorial WHO grade IV malignant glioma * Patient or partner(s) meets one of the following criteria: 1. Non-childbearing pote...