NCT02301130已完成1 期
Phase 1 Study of Mogamulizumab (KW-0761) in Combination With MEDI4736 (Durvalumab) and Mogamulizumab in Combination With Tremelimumab in Subjects With Advanced Solid Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 13
- 主要终点
- Number of subjects reporting serious adverse events
研究概览
简要总结
Mogamulizumab in Combination with MEDI4736 (Durvalumab) and Mogamulizumab in Combination with Tremelimumab in Subjects with Advanced Solid Tumors
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age ≥ 18 years;
- •Locally advanced or metastatic solid tumors;
- •Histologically or cytologically confirmed disease;
- •Failed or were intolerant to at least one prior systemic treatment regimen with oral or IV medications and have no additional therapy options known to prolong survival with the exception of PD-1 or PD-L1 blockade therapy for subjects who will be enrolled in treatment arm A. Subjects with non-small cell lung cancer must have received at least one platinum doublet regimen. Subjects with known epidermal growth factor receptor tyrosine kinase inhibitor activating mutations or anaplastic lymphoma kinase rearrangement must have also exhausted approved targeted therapy options;
- •The subject has a tumor suitable for biopsy and is willing to undergo tumor biopsy, preferably of the primary tumor, within 28 days prior to Cycle 1/Visit Day 1;
排除标准
- •Any concurrent chemotherapy, biologic, hormonal, radiation, or investigative therapy for cancer treatment within 21 days prior prior or within 6 weeks prior to Cycle 1/Visit Day 1 for nitrosoureas or mitomycin C;
- •Concurrent or prior use of immunosuppressive medication within 28 days;
- •Active or prior documented autoimmune, or inflammatory bowel disease, or inflammatory bowel disease. or systemic treatment for psoriasis within the past 5 years.;
- •Prior hypersensitivity reaction to monoclonal antibodies, other therapeutic proteins, or immunotherapy.
结局指标
主要结局
Number of subjects reporting serious adverse events
时间窗: Screening through 90 days after the last dose of study medication
Number of subjects experiencing dose-limiting toxicity
时间窗: First dose of study medications through 4 weeks after the last dose of study medication
Percentage of subjects reporting serious adverse events
时间窗: Screening through 90 days after the last dose of study medication
Number of subjects reporting adverse events
时间窗: Screening through 90 days after the last dose of study medication
Percentage of subjects reporting adverse events
时间窗: Screening through 90 days after the last dose of study medication
次要结局
未报告次要终点
研究者
研究点 (13)
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