NCT03746288

To Evaluate the Efficacy and Safety of CAN008 Combined With Re-irradiation (rRT) for Treating Patients With Recurrent Glioblastoma (GBM)

A Multicenter, Randomized, Open-label, Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of CAN008 Combined With Re-irradiation (rRT) for Treating Patients With Recurrent Glioblastoma (GBM)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: CANbridge Life Sciences Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, controlled study, aiming to evaluate the efficacy and safety of CAN008 administered once-weekly with rRT for treating first tumor recurrence in patients with GBM.

Detailed description

This is a multi-center, randomized, controlled clinical trial to evaluate the efficacy and safety of CAN008 administered once-weekly with re-radiation therapy (rRT) in patients with an initial relapse of GBM. The subjects will be randomized into the treatment group (CAN008 + rRT) or the control group (rRT). The investigational treatment can be continued as long as the subjects have experienced lasting clinical benefits (complete response \[CR\], partial response \[PR\] or stable disease \[SD\]). This study will be carried out in GBM subjects with an initial or second relapse. The subjects must have received standard care, including combination of radiotherapy and TMZ after surgical resection, and must be candidates for re-radiation therapy (rRT).

Conditions

• GBM

Interventions

Type	Name	Description
DRUG	CAN008	CAN008 400 mg weekly over no less than 30 minutes via intravenous drip, followed by rRT that same day

Timeline

• Start date: 2018-11-20
• Primary completion: 2021-07-01
• Completion: 2021-12-31
• First posted: 2018-11-19
• Last updated: 2018-11-19