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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study is double-blinded. Except for the non-blinded team, no other participants associated with this study should attempt to learn the treatment group assignment or which study treatment they are receiving.The unblinding of all subjects must be carried out after the database is locked.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to
- •Newly diagnosed glioblastoma.
- •Tumor excision rate ≥80%.
- •Karnofsky performance score ≥70.
排除标准
- •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.
研究组 & 干预措施
CAN008
CAN008 IV infusion weekly
干预措施: CAN008 (Drug)
placebo
Placebo IV infusion weekly
干预措施: Placebo (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 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
次要结局
- Overall survival (OS)(Up to 5 years)