A Phase 2 interventional study of CAN008 and Placebo in Newly-diagnosed Glioblastoma, sponsored by CANbridge Life Sciences Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-07-12.
Sponsored by CANbridge Life Sciences Ltd. · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria:
CAN008 IV infusion weekly
Drug: CAN008
Placebo IV infusion weekly
Drug: Placebo
Treatment in this study is divided into four periods. Period 1 (W1-W6) is the triple therapy period in which subjects in both groups will be given CAN008 + RT + TMZ. Period 2 (W7-W10) is the treatment-free (rest) period in which subjects do not receive any study drug/therapy. Period 3 (W11-W58) is the CAN008+TMZ maintenance therapy period in which subjects in both groups are given CAN008+TMZ. Period 4 (after W59) is the monotherapy period in which subjects are given CAN008 IV infusion weekly until disease progression.
Also known as: APG101
Treatment in this study is divided into four periods. Period 1 (W1-W6) is the triple therapy period in which subjects in both groups will be given placebo + RT + TMZ. Period 2 (W7-W10) is the treatment-free (rest) period in which subjects do not receive any study drug/therapy. Period 3 (W11-W58) is the placebo+TMZ maintenance therapy period in which subjects in both groups are given placebo+TMZ. Period 4 (after W59) is the monotherapy period in which subjects are given placebo IV infusion weekly until disease progression.
Progression-free survival (PFS)
To evaluate the efficacy of CAN008 plus temozolomide (TMZ) treatment in subjects with newly diagnosed glioblastoma (GBM) during and after radiation therapy
Time frame: Up to 3 years
Overall survival (OS)
Overall survival (OS)
Time frame: Up to 5 years
This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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CANbridge Life Sciences Ltd.