Phase 2 Study of CAN008 in Subjects With GBM

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.

Inclusion Criteria:

• Age 18 to 70.
• Newly diagnosed glioblastoma.
• Tumor excision rate ≥80%.
• Karnofsky performance score ≥70.

Exclusion Criteria:

• Medical history of brain radiation therapy or electric field treatment of tumor.
• Primary infratentorial glioblastoma, multifocal glioma (≥ 2), or leptomeningeal metastasis.
• Any malignant tumor (excluding WHO grade I-II low-grade astrocytomas, basal cell carcinoma, and carcinoma in situ).
• Receiving high-dose hormone therapy.