A Phase I/II, Dose Escalation Study To Assess The Safety and Tolerability of VAL201 In Patients With Advanced or Metastatic Prostate Cancer and Other Advanced Solid Tumours
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- ValiRx Plc
- 入组人数
- 12
- 主要终点
- Dose-Limiting Toxicity
研究概览
简要总结
Dose finding safety study of VAL201 in cancer patients.
详细描述
A Phase I/II, dose escalation study to assess the safety and tolerability of VAL201 in patients with locally advanced or metastatic prostate cancer and other advanced solid tumours.
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
- Male
- 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
Cohort 3: 2 mg/kg
VAL201-001 Sub-cutaneous injection. 2.0 mg/kg
干预措施: VAL201 (Drug)
Cohort 1: 0.5 mg/kg
VAL201-001 Sub-cutaneous injection. 0.5 mg/kg
干预措施: VAL201 (Drug)
Cohort 2: 1 mg/kg
VAL201-001 Sub-cutaneous injection. 1.0 mg/kg
干预措施: VAL201 (Drug)
Cohort 4: 4 mg/kg
VAL201-001 Sub-cutaneous injection. 4.0 mg/kg
干预措施: VAL201 (Drug)
Cohort 5: up to 8 mg/kg
VAL201-001 Sub-cutaneous injection. 8.0 mg/kg; potential to escalate to 16 mg/kg after 3 cycles according to clinician decision Flexibility of dosing enabled under protocol.
干预措施: VAL201 (Drug)
结局指标
主要结局
Dose-Limiting Toxicity
时间窗: The average timeframe is 18-26 weeks per subject
The number of Dose-Limiting Toxicity events is used to determine whether a maximum tolerated dose (MTD) is obtained.
次要结局
- Pharmacokinetics of VAL201. (Cmax)(The average timeframe is 18-26 weeks per subject)
- Pharmacokinetics of VAL201 (AUC 0-inf)(The average timeframe is 18-26 weeks per subject)