An Open-label, Safety and Tolerability Phase 1b Trial of CAN04, a Fully Humanized Anti-IL1RAP Monoclonal Antibody, and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Cantargia AB
- 入组人数
- 19
- 试验地点
- 3
- 主要终点
- Frequency of TEAEs (treatment-emergent adverse events) (Part 1)
研究概览
简要总结
This study will consider the safety and effectiveness of a study drug, CAN04, in combination with pembrolizumab, in the treatment of incurable or metastatic non-small-cell lung cancer (NSCLC), head and neck squamous cell carcinoma, urothelial cancer, or malignant melanoma. The study aims to establish a recommended dose of CAN04 in combination with the standard dose of pembrolizumab (Part 1), and in combination with pembrolizumab standard dose, and Standard of Care carboplatin and pemetrexed (Part 2 - subjects with stage IV, non-squamous metastatic NSCLC). CAN04, pembrolizumab. carboplatin and pemetrexed will be 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
CAN04 and pembrolizumab (Part 1)
Subjects will receive weekly doses of CAN04 in combination with pembrolizumab given as standard regimen
干预措施: CAN04 (Drug)
CAN04 and pembrolizumab (Part 1)
Subjects will receive weekly doses of CAN04 in combination with pembrolizumab given as standard regimen
干预措施: Pembrolizumab (Drug)
CAN04 + pembrolizumab + carboplatin + pemetrexed (Part 2)
Subjects will receive doses of CAN04 on Days 1 and 8 (Cycles 1 thru 4), and on Day 1 (Cycle 5 onwards) in combination with pembrolizumab given as standard regimen and carboplatin and pemetrexed standard of care
干预措施: CAN04 (Drug)
CAN04 + pembrolizumab + carboplatin + pemetrexed (Part 2)
Subjects will receive doses of CAN04 on Days 1 and 8 (Cycles 1 thru 4), and on Day 1 (Cycle 5 onwards) in combination with pembrolizumab given as standard regimen and carboplatin and pemetrexed standard of care
干预措施: Pembrolizumab (Drug)
CAN04 + pembrolizumab + carboplatin + pemetrexed (Part 2)
Subjects will receive doses of CAN04 on Days 1 and 8 (Cycles 1 thru 4), and on Day 1 (Cycle 5 onwards) in combination with pembrolizumab given as standard regimen and carboplatin and pemetrexed standard of care
干预措施: Carboplatin (Drug)
CAN04 + pembrolizumab + carboplatin + pemetrexed (Part 2)
Subjects will receive doses of CAN04 on Days 1 and 8 (Cycles 1 thru 4), and on Day 1 (Cycle 5 onwards) in combination with pembrolizumab given as standard regimen and carboplatin and pemetrexed standard of care
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Frequency of TEAEs (treatment-emergent adverse events) (Part 1)
时间窗: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
Frequency of TEAEs (treatment-emergent adverse events) (Part 2)
时间窗: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
Number of participants with DLTs (dose-limiting toxicities) (Part 1)
时间窗: Up to day 28
Number of participants with DLTs (dose-limiting toxicities) (Part 2)
时间窗: Up to day 28
Number of subjects with grade ≥3 TEAEs (Part 1)
时间窗: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
Number of subjects with grade ≥3 TEAEs (Part 2)
时间窗: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
Percentage of subjects with grade ≥3 TEAEs (Part 1)
时间窗: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
Percentage of subjects with grade ≥3 TEAEs (Part 2)
时间窗: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
Number of subjects with 1 or more SAEs (serious adverse events) (Part 1)
时间窗: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
Number of subjects with 1 or more SAEs (serious adverse events) (Part 2)
时间窗: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
Percentage of subjects with 1 or more SAEs (Part 1)
时间窗: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
Percentage of subjects with 1 or more SAEs (Part 2)
时间窗: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
Number of subjects with 1 or more TEAEs leading to dose modifications (Part 1)
时间窗: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
Number of subjects with 1 or more TEAEs leading to dose modifications (Part 2)
时间窗: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
Number of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 1)
时间窗: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
Number of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 2)
时间窗: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
Percentage of subjects with 1 or more TEAEs leading to dose modifications (Part 1)
时间窗: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
Percentage of subjects with 1 or more TEAEs leading to dose modifications (Part 2)
时间窗: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
Percentage of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 2)
时间窗: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
Percentage of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 1)
时间窗: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
次要结局
- Serum concentrations of CAN04 and pembrolizumab (Part 1)(From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first)
- Serum concentrations of CAN04 and pembrolizumab (Part 2)(From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first)
- Antidrug antibodies (ADAs) against CAN04(From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first)
- Change in serum IL-6 (interleukin-6) concentration (Part 1)(From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first)
- Change in serum CRP (C-reactive protein) concentration (Part 1)(From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first)
- Progression free survival (Part 1)(From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first)
- Progression free survival (Part 2)(From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first)
- Overall survival (Part 1)(Up to 36 months after 1st dose of last subject (or death))
- Overall survival (Part 2)(Up to 36 months after 1st dose of last subject (or death))
- Change in serum IL-6 (interleukin-6) concentration (Part 2)(From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first)
- Change in serum CRP (C-reactive protein) concentration (Part 2)(From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first)
- Overall response rate (ORR) (Part 1)(From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first)
- Overall response rate (ORR) (Part 2)(From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first)