A Phase 1/2, Open Label, Dose Escalation and Expansion Study of TAC-001 in Patients With Select Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
- 试验地点
- 12
- 主要终点
- Dose-Escalation Stage: RP2D for TAC-001
研究概览
简要总结
INCLINE-101 is an open label, multicenter Phase 1/2 study designed to evaluate safety, pharmacokinetics (PK), and preliminary anti-tumor activity of TAC-001 administered intravenously.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically-documented solid tumors.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or
- •Demonstrate adequate organ function.
排除标准
- •Prior history of or active malignant disease other than that being treated in this study.
- •Known brain metastases or cranial epidural disease.
- •A known hypersensitivity to the components of the study therapy or its' analogs.
研究组 & 干预措施
TAC-001 Single-Agent Dose-Escalation Cohorts
干预措施: TAC-001 (Drug)
结局指标
主要结局
Dose-Escalation Stage: RP2D for TAC-001
时间窗: 2-years
To identify the recommended dose phase 2 dose (RP2D) for further evaluation of TAC-001 when administered as monotherapy in subjects with advanced or metastatic solid tumors
Dose Expansion: Characterization of ORR for TAC-001
时间窗: 2 years
To evaluate preliminary efficacy of TAC-001 by estimating the overall response rate (ORR; combined complete response \[CR\] and partial response \[PR\]) as assessed by the Investigator per RECIST 1.1 and iRECIST
Dose Expansion: Characterization of duration of response for TAC-001
时间窗: 2 years
To evaluate preliminary efficacy of TAC-001 by estimating the duration of response as assessed by the Investigator per RECIST 1.1 and iRECIST
Dose Expansion: Characterization of clinical benefit rate for TAC-001
时间窗: 2 years
To evaluate preliminary efficacy of TAC-001 by estimating the clinical benefit rate as assessed by the Investigator per RECIST 1.1 and iRECIST
次要结局
- Maximum Plasma Concentration (Cmax)(2 years)
- Maximum Plasma Concentration (Tmax)(2 years)
- Area Under the Plasma Concentration-Time Curve (AUC)(2 years)
- Terminal Half-Life(2 years)
- Incidence and Severity of Nonserious Adverse Events (AEs) and Serious Adverse Events (SAEs)(2 years)
- Clearance of TAC-001(2 years)
- Evaluation of immunogenicity of TAC-001(2 years)