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A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of CAN008 Plus TMZ During and After Radiation Therapy in Subjects With Newly Diagnosed Glioblastoma
This is a multi-center, randomized, double-blind, placebo-controlled Phase 2 study whose objectives are to evaluate the clinical efficacy and safety of CAN008 plus TMZ during and after radiation therapy in newly-diagnosed subjects with glioblastoma who have undergone surgical excision.
This study plans to enroll approximately 117 subjects. Subjects determined as having met inclusion criteria through screening will be randomized into treatment groups (CAN008 + RT + TMZ, 78 subjects) and the control group (placebo + RT + TMZ, 39 subjects) in a ratio of 2:1.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Start Date
October 10, 2021
Primary Completion Date
January 31, 2024
Completion Date
August 31, 2024
Last Updated
July 12, 2022
117
ESTIMATED participants
CAN008
DRUG
Placebo
DRUG
Lead Sponsor
CANbridge Life Sciences Ltd.
Data Source & Attribution
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