Overview

Phase 2 Study of CAN008 in Newly Diagnosed GBM

Status:
Recruiting
Trial end date:
2024-08-31
Target enrollment:
0
Participant gender:
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 2
Accepts Healthy Volunteers?
No
Details
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.