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
Overview
- Phase
- Phase 2
- Intervention
- CAN008
- Conditions
- Newly-diagnosed Glioblastoma
- Sponsor
- CANbridge Life Sciences Ltd.
- Enrollment
- 117
- Locations
- 1
- Primary Endpoint
- Progression-free survival (PFS)
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 to
- •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.
Arms & Interventions
CAN008
CAN008 IV infusion weekly
Intervention: CAN008
placebo
Placebo IV infusion weekly
Intervention: Placebo
Outcomes
Primary Outcomes
Progression-free survival (PFS)
Time Frame: Up to 3 years
To evaluate the efficacy of CAN008 plus temozolomide (TMZ) treatment in subjects with newly diagnosed glioblastoma (GBM) during and after radiation therapy
Secondary Outcomes
- Overall survival (OS)(Up to 5 years)