A Phase 1 Study of the Clinical and Immunologic Effects of ALT-803, a Novel Recombinant IL-15 Complex in Patients With Advanced Solid Tumors: Melanoma, Renal Cell, Non-Small Cell Lung and Squamous Cell Head and Neck Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 5
- 主要终点
- Dose Limiting Toxicity
研究概览
简要总结
The proposed clinical trial is a phase I, open-label, multi-center, dose-escalation study of ALT-803 in patients with surgically incurable advanced solid tumors: melanoma, renal cell, non-small cell lung and squamous cell head and neck cancer
详细描述
This trial will investigate the safety and immunogenicity, immunomodulatory properties, and clinical benefits of treatment with weekly doses of ALT-803 in patients with advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
N-803 IV 0.3/0.5 ug/kg
干预措施: ALT-803 (Biological)
N-803 IV 1.0 ug/kg
干预措施: ALT-803 (Biological)
N-803 IV 3.0 ug/kg
干预措施: ALT-803 (Biological)
N-803 IV 6.0 ug/kg
干预措施: ALT-803 (Biological)
N-803 Subcutaneous 6.0 ug/kg
干预措施: ALT-803 (Biological)
N-803 Subcutaneous 10.0 ug/kg
干预措施: ALT-803 (Biological)
N-803 Subcutaneous 15.0 ug/kg
干预措施: ALT-803 (Biological)
N-803 Subcutaneous 20.0 ug/kg
干预措施: ALT-803 (Biological)
N-803 Intratumoral 10.0 ug/kg followed by N-803 15.0 ug/kg subcutaneous
干预措施: ALT-803 (Biological)
结局指标
主要结局
Dose Limiting Toxicity
时间窗: 9 months
The safety endpoint is the MTD of ALT-803, defined as the dose level below that at which ≥2 of 6 patients experience a DLT.
次要结局
- Number of Participants Who Developed Anti-drug Antibodies to ALT-803(14 days post final dose, up to 135 days)
- To Evaluate the Effect of Escalating Doses of ALT-803: Pharmacokinetics (Half Life and Tmax)(24 hours post dose)
- To Evaluate the Effect of Escalating Doses of ALT-803: Pharmacokinetics (Cmax)(24 hours after first dose)
- To Evaluate the Effect of Escalating Doses of ALT-803: Pharmacokinetics (AUC 0-t, AUC0-24, AUC0-infinity)(24 hours after first dose)
- To Evaluate the Effect of Escalating Doses of ALT-803: Interferon Gamma (IFN-γ)(Cycle 1 Week 1, pre-dose; Cycle 1 Week 1, 30 minutes post dose; Cycle 1 Week 1, 2 hours post dose; Cycle 1 Week 1, 4 hours post dose; Cycle 1 Week 1, 8 hours post dose; Cycle 1 Week 1, 24 hours post dose)
- Objective Response Rate(Up to 6 months)