A Phase 1 Study of SGN-CD228A in Select Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Seagen Inc.
- 入组人数
- 88
- 试验地点
- 14
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
This trial will study SGN-CD228A to find out whether it is an effective treatment for different kinds of cancer. It will also look at what side effects (unwanted effects) may occur. The study will have two parts. Part 1 of the study will find out how much SGN-CD228A should be given for treatment and how often. Part 2 of the study will use the dose found in Part 1 and look at how safe and effective the treatment is.
详细描述
This study is designed to evaluate the safety, tolerability, PK, and antitumor activity of SGN-CD228A in select advanced solid tumors. The study will include dose escalation and dose expansion, with multiple disease-specific expansion cohorts.
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
SGN-CD228A
SGN-CD228A monotherapy
干预措施: SGN-CD228A (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: Up to approximately 3.5 years
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Number of participants with laboratory abnormalities
时间窗: Up to approximately 3.5 years
Number of participants with dose limiting toxicities
时间窗: Up to approximately 3.5 years
次要结局
- Best response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1(Up to approximately 3.5 years)
- Best response per modified RECIST (mRECIST) (participants with pleural mesothelioma only)(Up to approximately 3.5 years)
- Duration of complete response(Up to approximately 3.5 years)
- Maximum concentration (Cmax) of antibody-conjugated monomethylauristatin E (acMMAE)(Up to approximately 3.5 years)
- Ctrough of total antibody(Up to approximately 3.5 years)
- Objective response rate (ORR)(Up to approximately 3.5 years)
- Progression-free survival (PFS)(Up to approximately 3.5 years)
- Overall survival (OS)(Up to approximately 3.5 years)
- Duration of objective response (DOR)(Up to approximately 3.5 years)
- Cmax of free MMAE(Up to approximately 3.5 years)
- Cmax of total antibody(Up to approximately 3.5 years)
- Time to maximum concentration (Tmax) of acMMAE(Up to approximately 3.5 years)
- Tmax of free MMAE(Up to approximately 3.5 years)
- Area under the plasma concentration-time curve from time 0 to the last available [AUC (0-last)] of acMMAE(Up to approximately 3.5 years)
- AUC(0-last) of total antibody(Up to approximately 3.5 years)
- Incidence of anti-drug antibodies (ADA)(Up to approximately 3.5 years)
- Tmax of total antibody(Up to approximately 3.5 years)
- Trough concentration (Ctrough) of acMMAE(Up to approximately 3.5 years)
- Ctrough of free MMAE(Up to approximately 3.5 years)
- AUC(0-last) of free MMAE(Up to approximately 3.5 years)