A Dose-escalation, Dose-finding, and Expansion Study of XL495 as a Single Agent and in Combination Therapy in Participants With Locally Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Exelixis
- 入组人数
- 9
- 试验地点
- 10
- 主要终点
- Dose-escalation and Dose-finding Stages: Number of Participants with Treatment-Emergent Adverse Events
研究概览
简要总结
The goal of this study is to obtain safety, tolerability, PK, and preliminary clinical antitumor activity for XL495 as a single agent and in combination with select cytotoxic agents in participants with locally advanced or metastatic tumors for whom life-prolonging therapies do not exist or available therapies are intolerable/no longer effective.
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
- 18 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
Dose Escalation XL495
Group(s) of participants with advanced metastatic tumors who will receive increasing doses of XL495.
干预措施: XL495 (Drug)
Dose Finding XL495 + ADC cytotoxic agents
Group(s) of participants with advanced metastatic tumors who will receive XL495 and Antibody drug conjugate (ADC) cytotoxic agents together at increasing doses.
干预措施: XL495 (Drug)
Dose Finding XL495 + ADC cytotoxic agents
Group(s) of participants with advanced metastatic tumors who will receive XL495 and Antibody drug conjugate (ADC) cytotoxic agents together at increasing doses.
干预措施: ADC cytotoxic agents (Drug)
Expansion XL495 + ADC cytotoxic agents
Group(s) of participants with urothelial cancer who will receive XL495 and ADC cytotoxic agents at the recommended dosage(s) of expansion (RDE [s]) determined during the dose-escalation and dose-finding stages.
干预措施: XL495 (Drug)
Expansion XL495 + ADC cytotoxic agents
Group(s) of participants with urothelial cancer who will receive XL495 and ADC cytotoxic agents at the recommended dosage(s) of expansion (RDE [s]) determined during the dose-escalation and dose-finding stages.
干预措施: ADC cytotoxic agents (Drug)
结局指标
主要结局
Dose-escalation and Dose-finding Stages: Number of Participants with Treatment-Emergent Adverse Events
时间窗: Up to 18 months
Dose-escalation and Dose-finding Stages: Number of Participants with Dose-limiting Toxicities
时间窗: Up to 18 months
Expansion Stage: Number of Participants with Treatment-Emergent Adverse Events
时间窗: Up to 19 months
Expansion Stage: Objective Response Rate (ORR) As Assessed by Investigator Per RECIST 1.1
时间窗: Until disease progression or death, up to approximately 19 months
ORR is defined as the percentage of participants with the best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), as assessed by the Investigator per RECIST 1.1.
次要结局
- Dose-escalation and Dose-finding Stages: Concentration of XL495 in Plasma(Pre-dose and multiple post-dose time points, up to 18 months)
- Dose-escalation and Dose-finding Stages: Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Time Curve (AUC) of XL495(Pre-dose and multiple post-dose time points, up to 18 months)
- Dose-escalation and Dose-finding Stages: PK Parameter Maximum Plasma Concentration of XL495 (Cmax)(Pre-dose and multiple post-dose time points, up to 18 months)
- Dose-escalation and Dose-finding Stages: PK Parameter Time to Cmax of XL495 (Tmax)(Pre-dose and multiple post-dose time points, up to 18 months)
- Dose-escalation and Dose-finding Stages: PK Parameter Apparent Clearance with Oral Administration of XL495 (CL/F)(Pre-dose and multiple post-dose time points, up to 18 months)
- Dose-escalation and Dose-finding Stages: PK Parameter Apparent Terminal Elimination Half-life of XL495 (t1/2)(Pre-dose and multiple post-dose time points, up to 18 months)
- Expansion Stage: Duration of Response (DOR) As Assessed by Investigator per RECIST 1.1(Until disease progression or death, up to approximately 19 months.)
- Expansion Stage: Progression-free Survival (PFS), as Assessed by Investigator per RECIST 1.1(Until disease progression or death, up to approximately 19 months.)
- Expansion Stage: Concentration of XL495 in Plasma(Pre-dose and multiple post-dose time points, up to 18 months)
- Expansion Stage: Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Time Curve (AUC) of XL495(Pre-dose and multiple post-dose time points, up to 18 months)
- Expansion Stage: PK Parameter Maximum Plasma Concentration of XL495 (Cmax)(Pre-dose and multiple post-dose time points, up to 18 months)
- Expansion Stage: PK Parameter Time to Cmax of XL495 (Tmax)(Pre-dose and multiple post-dose time points, up to 18 months)
- Expansion Stage: PK Parameter Apparent Clearance with Oral Administration of XL495 (CL/F)(Pre-dose and multiple post-dose time points, up to 18 months)
- Expansion Stage: PK Parameter Apparent Terminal Elimination Half-life of XL495 (t1/2)(Pre-dose and multiple post-dose time points, up to 18 months)