jRCT2080222258已完成1 期
A Japanese Phase I Open-label Dose-escalation Trial of Sym004 Administered as Monotherapy in Japanese Subjects With Advanced Solid Tumors
Merck Serono Co., Ltd., Japan1 个研究点目标入组 24 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicity
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •(1)Japanese male or female subjects aged greater than or equal to 20 years at the time of informed
- •(2)consent signature
- •(3)Histologically or cytologically confirmed cancer
- •(4)Refractory or recurrent advanced late stage solid tumors without available therapeutic options which are likely to provide patient benefit (failure and/or intolerance to standard anti-cancer therapy)
- •(5)Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •(6)Life expectancy of at least 3 months
- •(7)Written informed consent given before any trial-related activities are carried out
排除标准
- •(1)Subjects with symptomatic brain metastases
- •(2)Subjects who received total resection or irradiation of the target lesion
- •(3)Received any of the following medications within 4 weeks before the first administration of Sym004 at Week 1: cytotoxic or cytostatic anti-cancer therapy, antibody therapy, tyrosine kinase inhibitors, and any investigational agent
- •(4)Received vaccine therapy as anticancer treatment within 12 weeks before the first administration of Sym004 at Week 1
- •(5)Diarrhea of greater than Grade 1 according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 (v4.03)
- •(6)Skin manifestation of greater than Grade 1 according to NCI-CTCAE (v4.03)
- •(7)Magnesium of less than 0.9 milligram per deciliter (mg/dL)
- •(8)Abnormal organ or bone marrow function as defined in the protocol
- •(9)Received immunosuppressive agents (including systemic corticosteroids used at doses above 20 milligram per day (mg/day) of prednisolone or equivalent) within 4 weeks before the first administration of Sym004 at Week 1
- •(10)Active severe infection, any other concurrent disease or medical conditions that are deemed to interfere with the conduct of the trial as judged by the Investigator
- •(11)Known human immunodeficiency virus (HIV) positive, active Hepatitis B or C, or uncontrolled allergic conditions or allergy to Sym004 or its components
- •(12)Clinically significant cardiac disease or concurrent, uncontrolled medical condition
- •(13)Known previous Grade 3 to 4 infusion-related reactions, according to NCI-CTCAE (v4.03), with chimeric monoclonal antibodies
- •(14)Other protocol defined exclusion criteria could apply
结局指标
主要结局
Dose Limiting Toxicity
时间窗: Up to Week 4
[Designated as safety issue: Yes]
Number of subjects with Adverse Events
时间窗: Up to 4 weeks after the last Sym004 administration
[Designated as safety issue: Yes]
次要结局
- Pharmacokinetic profile of Sym004(Up to 8 weeks after the last Sym004 administration)
研究者
研究点 (1)
Loading locations...
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