A Phase 1b Study of GX-I7 in Combination With Cyclophosphamide in Patients With Metastatic or Recurrent Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Incidence of DLT
研究概览
简要总结
This is a Phase 1b study to explore the safety and efficacy of GX-I7 in combination with CPA in patients with metastatic or recurrent solid tumors.
详细描述
This is a Phase 1b study to explore the safety and efficacy of GX-I7 in combination with CPA in patients with metastatic or recurrent solid tumors.
This is 4 dose levels and increase dose level after confirm DLT of the previous dose.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological confirmation of solid tumor, for which no standard therapy exists or is available any longer.
- •Aged ≥19 years(Korean age).
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Life expectancy ≥12 weeks.
- •Adequate hematological and end organ function defined by the following
- •laboratory results obtained within 14 days prior to Cycle 1 Day 1 (C1D1)
- •Female subjects of childbearing potential (including a female who has undergone tubal ligation) requires a negative serum pregnancy test performed within 14 days prior to C1D
- •Have an evaluable lesion(s) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- •Subjects to be enrolled in the Phase 2a stage must be able to provide pre-treatment tissue biopsy or archival tissue and must have a tumor lesion.
- •Providing the signed informed consent form (ICF).
排除标准
- •Unable to adhere to the study procedures and follow-up procedures.
- •Pregnant or lactating subjects.
- •Have alcoholic or other hepatitis, liver cirrhosis, or genetic liver disease.
- •Have uncontrolled type 2 diabetes mellitus.
- •Have history of a major surgery within 28 days prior to C1D1 or are anticipated to require a major surgery during the study.
- •Have an evidence of severe or uncontrolled systemic disease, uncontrolled hypertension.
- •Have received any other investigational or approved anticancer therapy within 3 weeks prior to C1D
- •With a positive result of human immunodeficiency virus (HIV) infection.
研究组 & 干预措施
Cyclophosphamide and GX-I7
Cyclophosphamide and determined dose of GX-I7 of each cycle
干预措施: GX-I7 (Drug)
Cyclophosphamide and GX-I7
Cyclophosphamide and determined dose of GX-I7 of each cycle
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Incidence of DLT
时间窗: within cycle 1(28days)
Incidence of nature of DLTs
Incidence and characteristics of AE
时间窗: up to 24 months
Incidence, nature and severity of adverse events graded according to NCI CTCAEv4.03
ORR
时间窗: up to 6 months
ORR defined as complete response (CR) or partial response (PR) per RECIST v1.1
次要结局
- concentration of GX-I7(up to cycle 3 day 1(approximately 8 weeks))
- Incidence of ADAs(up to 24 months)