Overview
Phase 2 Study of CAN008 in Newly Diagnosed GBM
Status:
Recruiting
Recruiting
Trial end date:
2024-08-31
2024-08-31
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
CANbridge Life Sciences Ltd.
Criteria
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.