The trial, due to be conducted in China, received the approval based on investigational new drug (IND) application submitted by CANbridge to CFDA.
The placebo-controlled study is designed to examine the efficacy and safety of weekly CAN008 + re-radiation therapy (rRT) in GBM patients.
Its primary endpoint is overall survival (OS) as determined from randomisation.
For the biomarker-guided study, CANbridge plans to dose the first patient later this year.
CANbridge Life Sciences chairman and CEO James Xue said: “CAN008, our lead candidate, is the first innovative drug in Class I we have advanced to a clinical trial programme in mainland China.
“We hope it will provide new and effective treatment for glioblastoma multiforme, which is a severely underserved medical condition in Asia.”
GBM is an aggressive and highly malignant brain cancer, with few available treatment options in China.
It is caused by malignant tumours that develop in the supportive tissue of the brain (astrocyte cells).
The CAN008 is a fully human fusion protein that inhibits the CD95 ligand, a member of the tumour necrosis factor (TNF) family.
By blocking CD95 ligand, CAN008 restores the immune system’s anti-tumour response and inhibits invasive tumour cell growth.
In November last year, CANbridge unveiled interim safety results from the ongoing CAN008 GBM Phase I trial in Taiwan.
So far the trial, which has completed enrolment with ten patients, has not reported any CAN008-related serious adverse events (SAEs).