Two-Part, Open-Label, Multi-Center, Phase 1/2 Study of Anti-GM2 Ganglioside Monoclonal Antibody BIW-8962 as Monotherapy in Subjects With Previously Treated Advanced/Recurrent Lung Cancer or Mesothelioma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Phase 1 - To determine Maximum Tolerated Dose(MTD)
研究概览
简要总结
This Phase 1/2 study is designed to assess the following: safety and tolerability of BIW-8962, Dose Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD), Recommended Phase 2 Dose (RP2D) in Phase 1 in subjects with advanced/recurrent lung cancers or mesothelioma and preliminary efficacy in Phase 2 in subjects with advanced/recurrent Small Cell Lung Cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Phase 1: histopathological-documented, measurable or non-measurable unresectable, advanced primary or recurrent SCLC, NSCLC or mesothelioma
- •Phase 2: measurable, unresectable advanced or recurrent SCLC
- •A life expectancy > 3 months
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 at study entry
- •Echocardiogram or multigated acquisition (MUGA) scan with left ventricular ejection fraction (LVEF) ≥ 50%, or ≥ institution's established lower limit of normal
- •Adequate hematologic, hepatic, renal and lung function
排除标准
- •Subject received cytotoxic anti-cancer chemotherapy, orally available signaling pathway-targeted therapy, hormonal therapy, radiotherapy, immunotherapy, or investigational agents within 3 weeks prior to the first dose
- •Subject received monoclonal antibodies within 4 weeks of the first dose
- •Major surgery within 4 weeks prior to the first dose
- •Known symptomatic brain metastases
- •Clinically significant cardiovascular disease
- •Leptomeningeal disease
- •Uncontrolled intercurrent illness including ongoing or active infection, uncontrolled diabetes, etc
- •Known HIV disease or acquired immunodeficiency syndrome-related illness
- •A psychiatric illness, disability or social situation
- •Hypersensitivity reaction to monoclonal antibodies, other therapeutic proteins
- •A history of primary brain/CNS malignancy
- •Neurological paraneoplastic syndrome
研究组 & 干预措施
BIW-8962
Phase 1 - Dose escalation based on the BIW-8962 tolerability and safety data obtained from three subjects enrolled in a cohort (first cycle of treatment), enrollment at the next dose level or additional subjects into the ongoing cohort will occur
Phase 2 - Recommended dose determined in Phase 1
干预措施: BIW-8962 (Drug)
结局指标
主要结局
Phase 1 - To determine Maximum Tolerated Dose(MTD)
时间窗: First 3-week cycle of treatment
Phase 1 -Adverse Event collection and assessment will be done for all potentially treated subjects to assess the safety, tolerability, and determine the DLTs, maximum tolerated dose (MTD).
Phase 2 - To assess the objective response rate(Partial Response and Complete Response)
时间窗: Until Progressive Disease (PD) determined
Phase 2 - Tumor response and progression will be evaluated every 6 weeks using RECIST v 1.1. Partial Response (PR) or Complete Response (CR) will be confirmed 4 weeks after first detection of response.
次要结局
- Phase 1 - To evaluate preliminary efficacy(Until Progressive Disease (PD) determined)
- Phase 1 - To determine the q3w pharmacokinetic profile of BIW-8962(Pre-dose, and Day 1, 2, 3, 5, 8, 12 and 15 in Cycle 1 and 3, Pre-dose in Cycle 2, 4, 5,and up to Cycle 6)
- Phase 2 - To assess safety and tolerance(Every 3 weeks, until 45days after the last dose or within 7 days prior to the initiation of subsequent anti-cancer treatment)