A Phase 1b, Dose-escalation Study to Evaluate the Safety, Tolerability, and the Lymphocyte Increasing Effects of GX-I7 Intramuscular Administration in Patients With Glioblastoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Incidence, nature and severity of Adverse events
研究概览
简要总结
Patients will be enrolled in two stages:
- Dose-escalation stage: Approximately 12-24 patients will be enrolled.
详细描述
Detailed Description:
• Dose-escalation stage : designed as classical 3+3 to determine MTD(Maximum tolerable dose), RP2D(Recommended Phase 2 Dose) and DLT(Dose-limiting toxicity)s to evaluate approximately four dose levels of GX-I7
- pre-determined dose(Level I)~ pre-determined dose(Level IV)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1
Patients will receive treatment with GX-I7 at a pre-determined dose (Level I) on Day1 of each cycle.
干预措施: GX-I7 (Drug)
Cohort 2
Patients will receive treatment with GX-I7 at a pre-determined dose (Level II) on Day1 of each cycle.
干预措施: GX-I7 (Drug)
Cohort 3
Patients will receive treatment with GX-I7 at a pre-determined dose (Level III) on Day1 of each cycle.
干预措施: GX-I7 (Drug)
Cohort 4
Patients will receive treatment with GX-I7 at a pre-determined dose (Level IV) on Day1 of each cycle.
干预措施: GX-I7 (Drug)
Cohort 5(Dose-expansion)
Optimal fixed dose of GX-I7 from Dose-escalation stage on Day1 of each cycle (Maximum tolerable dose or Maximum efficacious dose or Maximum administered dose level or consecutive lower or upper dose level which does not exceed Maximum tolerable dose based on Safety Monitoring Committee(SMC) decision)
干预措施: GX-I7 (Drug)
结局指标
主要结局
Incidence, nature and severity of Adverse events
时间窗: Through study completion, an average of 2 years
Incidence, nature and severity of adverse events graded according to NCI CTCAE v4.0
DLT(Dose-Limiting Toxicity) Assessment
时间窗: Through study completion, an average of 2 years
Incidence and nature of DLT(Dose-Limiting Toxicity)s
次要结局
- Exploratory Biomarker [serum Interleukin-7](Through study completion, an average of 2 years)
- PD(pharmacodynamic) profile [ALC result](Through study completion, an average of 2 years)
- Anti-tumor Activity [OS](Through study completion, an average of 2 years)
- Anti-tumor Activity [PFS](Through study completion, an average of 2 years)
- Immunogenicity[ ADA and neutralizing antibody](Through study completion, an average of 2 years)