A Phase 1 Study of the Safety and Tolerability of BMS 986148 in Subjects With Advanced and/or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Incidence of SAEs (Serious Adverse Events)
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of Mesothelin-ADC in subjects with advanced and/or metastatic solid tumors.
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
- •Must have histological confirmation of advanced and/or metastatic solid
- •tumors which are expected to express mesothelin
- •Must have received and either progressed or been intolerant to the standard treatment regimen in the advanced or metastatic setting, if such a therapy exists
- •Must have measurable tumor per Response Evaluation Criteria in Solid Tumors (RECIST) or modified RECIST for malignant pleural mesothelioma
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
排除标准
- •Cancer metastases in the brain
- •Uncontrolled or significant cardiovascular disease
- •Moderate eye disorders
- •Moderate peripheral neuropathy
- •Known past or active hepatitis B or C infection
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
BMS-986148 intravenous infusion
干预措施: BMS-986148 (Drug)
结局指标
主要结局
Incidence of SAEs (Serious Adverse Events)
时间窗: Day 1 to 30 days after the last dose of BMS-986148
SAEs leading to discontinuation, Death and Frequency of laboratory test toxicity grade shifting from baseline
Grade of SAEs
时间窗: Day 1 to 30 days after the last dose of BMS-986148
SAEs leading to discontinuation, Death and Frequency of laboratory test toxicity grade shifting from baseline
Incidence of AEs (Adverse Events)
时间窗: Day 1 to 30 days after the last dose of BMS-986148
AEs leading to discontinuation, Death and Frequency of laboratory test toxicity grade shifting from baseline
Grade of AEs
时间窗: Day 1 to 30 days after the last dose of BMS-986148
AE leading to discontinuation, Death and Frequency of laboratory test toxicity grade shifting from baseline
次要结局
- Cmax Accumulation Index; ratio of Cmax at steady state to Cmax after the first dose (AI_Cmax)(Day 1 to day 84)
- Ctau Accumulation Index; ratio of Ctau at steady state to Ctau after the first dose (AI_Ctau)(Day 1 to day 84)
- Response Evaluation Criteria in Solid Tumors (RECIST)(Day 1 to 30 days after the last dose of BMS-986148)
- Maximum observed concentration (Cmax)(Day 1 to day 84)
- Time of maximum observed concentration (Tmax)(Day 1 to day 84)
- Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)](Day 1 to day 84)
- Area under the concentration-time curve in one dosing interval [AUC(TAU)](Day 1 to day 84)
- Average concentration (Cavg)(Day 1 to day 84)
- Half life (T-half)(Day 1 to day 84)
- Trough observed plasma concentration (Ctrough)(Day 1 to day 84)
- Concentration in a dosing interval (Ctau)(Day 1 to day 84)
- Total body clearance (CLT)(Day 1 to day 84)
- Apparent volume of distribution at steady state (Vss)(Day 1 to day 84)
- Volume of distribution of terminal phase (Vz)(Day 1 to day 84)
- AUC Accumulation Index; ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI_AUC)(Day 1 to day 84)