JPRN-jRCT2080221527已完成1 期
A Phase I study of WT4869 in patients with advanced solid malignancies
Chugai Pharmaceutical Co., Ltd., Dainippon Sumitomo Pharma. Co., Ltd.0 个研究点目标入组 25 人开始时间: 2011年7月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
研究概览
简要总结
This study was conducted to evaluate the safety of WT4869 in patients with advanced solid tumors and to evaluate the MTD of WT4869. In addition, efficacy and biomarkers were exploratory examined. No DLT occurred during the DLT evaluation in both the intradermal and subcutaneous cohorts, suggesting that neither the intradermal cohort nor the subcutaneous cohort reached MTD at the doses studied in this study. Drug was well tolerated in both the intradermal and subcutaneous cohorts.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •- Histologically or cytologically confirmed solid malignancies
- •- HLA-A*2402
- •- Advanced cancer patient who is refractory to standard therapy or no established treatment exists
排除标准
- •- Concomitant infection requiring systemic administration of antibiotics or antiviral drugs
- •- Positive for either HIV antibody, HBs antigen or HCV antibody testing within 90 days before entry
- •- Brain metastasis which is symptomatic or requiring treatment, excluding primary malignant brain tumor
研究者
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