NCT02853565

A Study of CAN008 for Newly Diagnosed Glioblastoma Multiforme

A Phase I Study of CAN008 Plus Concomitant Temozolomide During and After Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: CANbridge Life Sciences Ltd. · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate CAN008 safety, tolerability, and pharmacokinetics (PK) of CAN008 when administered concurrent Plus Concomitant Temozolomide During and After Radiation Therapy in Patients with Newly Diagnosed Glioblastoma Multiforme.

Detailed description

CAN008 is a glycosylated fusion protein consisting of the extracellular domain of human CD95 (APO-1/Fas) and the Fc domain of human IgG1. CAN008 blocks the interaction between CD95 and its cognate ligand CD95L. The target of CAN008 is the inhibition of CD95L. CD95L is expressed in glioblastoma whose cells are resistant to CD95-mediated apoptosis. CD95L was shown to be a crucial trigger in invasion and migration of tumor cells and neutralizing CD95L abolishes the invasive capacity of glioblastoma cells. The purpose of the study is: 1. To describe the toxicity associated with this regimen in adult patients with newly diagnosed glioblastoma multiforme. 2. To determine the duration of disease free survival and overall survival associated with this therapy.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	CAN008	The dose escalation in the phase I study including 200mg in the first cohort and 400mg in the second cohort to Recommended for Phase 2 Dose (RP2D)

Timeline

• Start date: 2016-08-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2016-08-03
• Last updated: 2018-11-08

Locations

2 sites across 1 country: Taiwan