Phase 2 Study of CAN008 in Subjects With GBM
- Registration Number
- NCT05447195
- Lead Sponsor
- CANbridge Life Sciences Ltd.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 117
- Age 18 to 70.
- Newly diagnosed glioblastoma.
- Tumor excision rate ≥80%.
- Karnofsky performance score ≥70.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CAN008 CAN008 CAN008 IV infusion weekly placebo Placebo Placebo IV infusion weekly
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) 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 Outcome Measures
Name Time Method Overall survival (OS) Up to 5 years Overall survival (OS)
Trial Locations
- Locations (1)
Beijing Tiantan Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China