A Phase 1 Study of SEA-TGT (SGN-TGT) in Subjects With Advanced Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Seagen Inc.
- 入组人数
- 133
- 试验地点
- 36
- 主要终点
- Number of participants with a dose-limiting toxicity (DLT) at each dose level
研究概览
简要总结
This trial will look at a drug called SEA-TGT (also known as SGN-TGT) to find out whether it is safe for patients with solid tumors and lymphomas. It will study SEA-TGT to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether SEA-TGT works to treat solid tumors and lymphomas.
The study will have four parts. Part A of the study will find out how much SEA-TGT should be given to patients. Part B will use the dose found in Part A to find out how safe SEA-TGT is and if it works to treat solid tumors and lymphomas. Part C will study how well SEA-TGT with sasanlimab works to treat solid tumors. Part D will study how well SEA-TGT with brentuximab vedotin works to treat classical Hodgkin lymphoma (cHL).
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
- 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
SEA-TGT Monotherapy (Parts A and B)
SEA-TGT
干预措施: SEA-TGT (Drug)
SEA-TGT + sasanlimab Combination Therapy (Part C)
SEA-TGT + sasanlimab
干预措施: SEA-TGT (Drug)
SEA-TGT + sasanlimab Combination Therapy (Part C)
SEA-TGT + sasanlimab
干预措施: sasanlimab (Drug)
SEA-TGT + brentuximab vedotin Combination Therapy (Part D)
SEA-TGT + brentuximab vedotin
干预措施: SEA-TGT (Drug)
SEA-TGT + brentuximab vedotin Combination Therapy (Part D)
SEA-TGT + brentuximab vedotin
干预措施: brentuximab vedotin (Drug)
结局指标
主要结局
Number of participants with a dose-limiting toxicity (DLT) at each dose level
时间窗: Up to 21 days
To be summarized using descriptive statistics
Number of participants with adverse events (AEs)
时间窗: Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years
An AE is any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Number of participants with laboratory abnormalities by grade
时间窗: Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years
To be summarized using descriptive statistics
次要结局
- Objective Response Rate (ORR)(Up to approximately 3 years)
- Area under the concentration-time curve (AUC)(Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years)
- Time to maximum concentration (tmax)(Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years)
- Complete response (CR) rate(Up to approximately 3 years)
- Duration of objective response(Up to approximately 3 years)
- Maximum concentration (Cmax)(Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years)
- Trough concentration (Ctrough)(Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years)
- Duration of CR(Up to approximately 3 years)
- Duration of progression-free survival(Up to approximately 3 years)
- Duration of overall survival(Up to approximately 3 years)
- Number of participants with antidrug antibodies (ADA)(Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years)