A Multicentre, Open Label, Dose Escalation, Phase 1 Study in Patients With Unresectable or Metastatic Melanoma Receiving IMP321 (LAG-3Ig Fusion Protein-eftilagimod Alpha) as an Adjunctive Therapy to Anti-PD-1 Therapy With Pembrolizumab
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 7
- 主要终点
- To asses frequency of adverse events
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability and recommended phase 2 dose of a new drug, known as IMP321, in combination with pembrolizumab when given to patients with unresectable or metastatic melanoma.
研究设计
- 研究类型
- Interventional
- 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
IMP321 dose escalation
IMP321 administered fortnightly in addition to SOC pembrolizumab.
干预措施: IMP321 (eftilagimod alpha) (Drug)
IMP321 dose escalation
IMP321 administered fortnightly in addition to SOC pembrolizumab.
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
To asses frequency of adverse events
时间窗: From the time of inform consent form signature until 30 days after end of treatment
To assess the recommended phase 2 dose
时间窗: From the time of inform consent form signature until 30 days after end of treatment
To asses severity of adverse events
时间窗: From the time of inform consent form signature until 30 days after end of treatment
To asses duration of adverse events
时间窗: From the time of inform consent form signature until 30 days after end of treatment
次要结局
- Progression-free survival(Up to 12 months)
- Time to next treatment (TTNT)(Up to 12 months)
- Best overall response rate (ORR) to irRC and RECIST 1.1(From the time of inform consent form signature until 30 days after end of treatment.)
- Overall survival (part B only)(Up to 12 months)