Phase 2 Study of CAN008 in Subjects With GBM

CANbridge Life Sciences

Status and phase: Enrolling; Phase 2

Conditions: Newly-diagnosed Glioblastoma

Treatments: Drug: CAN008; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05447195

CAN008-G-202

CTR20211888 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 117 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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117 participants in 2 patient groups, including a placebo group

CAN008

Experimental group

Description:

CAN008 IV infusion weekly

Treatment:

Drug: CAN008

placebo

Placebo Comparator group

Description:

Placebo IV infusion weekly

Treatment:

Drug: Placebo