A Phase 1b/2, Open Label, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacodynamics and Antitumor Activity of GX-I7 in Combination With Pembrolizumab in Subjects With Refractory or Relapsed (R/R) TNBC
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 12
- 主要终点
- Incidence, nature and severity of adverse events
研究概览
简要总结
To evaluate the safety and tolerability of escalating doses GX-I7 in combination with standard dose pembrolizumab, and to evaluate objective response rate (ORR) in subjects with refractory or relapsed TNBC
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Triple negative must be defined as guidelines of American Society of Clinical Oncology(ASCO)/ College of American Pathologist(CAP): Estrogen Receptor (ER) < 1% positive tumor nuclei, Progesterone Receptor (PR) < 1% positive tumor nuclei, and negative for HER2 by IHC 1+, 0 or negativity status confirmed by in situ hybridization (ISH).
- •Subject must have received anthracycline and taxane based chemotherapy for TNBC
- •Has measurable disease as defined by RECIST 1.1 as assessed by the the local site Investigator/radiology.
- •Female subjects, age ≥ 19 years at the time of consent.
排除标准
- •Known severe hypersensitivity (≥ Grade 3) to pembrolizumab, pembrolizumab formulation excipients or GX-I7 formulation excipients or cyclophosphamide formulation.
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (ie, CTLA-4, OX-40, CD137) or has previously participated in a Merck pembrolizumab (MK-3475) clinical trial.
研究组 & 干预措施
combination with CPA, GX-I7, and pembrolizumab
Experimental: combination
Assigned interventions: CPA, GX-I7 and pembrolizumab
干预措施: GX-I7 (Drug)
combination with CPA, GX-I7, and pembrolizumab
Experimental: combination
Assigned interventions: CPA, GX-I7 and pembrolizumab
干预措施: Pembrolizumab(KEYTRUDA®) (Drug)
combination with CPA, GX-I7, and pembrolizumab
Experimental: combination
Assigned interventions: CPA, GX-I7 and pembrolizumab
干预措施: Cyclophosphamide (Drug)
combination with GX-I7, and pembrolizumab
Experimental: combination
Assigned interventions: GX-I7 and pembrolizumab (without CPA)
干预措施: GX-I7 (Drug)
combination with GX-I7, and pembrolizumab
Experimental: combination
Assigned interventions: GX-I7 and pembrolizumab (without CPA)
干预措施: Pembrolizumab(KEYTRUDA®) (Drug)
结局指标
主要结局
Incidence, nature and severity of adverse events
时间窗: up to 24month
graded according to NCI CTCAE v5.0
Incidence and nature of DLTs
时间窗: during the first 5 weeks
To evaluate the safety and tolerability of GX-I7 in combination with standard dose pembrolizumab
Objective response rate (ORR)
时间窗: up to 24month
defined as percentage of subjects with a complete response (CR) or partial response (PR) per RECIST v.1.1
次要结局
未报告次要终点