JPRN-UMIN000026961已完成1 期
An Open label Phase I Study to Evaluate the Safety and Efficacy of OBP-301 with Pembrolizumab in Patients with advanced solid tumors. - OBP+Pem
ational Cancer Center Hospital East0 个研究点目标入组 22 人开始时间: 2017年7月31日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of study Day 1. 2)Has an active autoimmune disease that has required systemic treatment in past 2 years. 3)Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study Day 1. 4)Has known active central nervous system metastases and/or carcinomatous meningitis. 5)Has had prior anti-cancer monoclonal antibody chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or immunotherapy targeted to PD-1, PD-L1, PD-L2 within 4 weeks prior to Day 1 or OBP-301 study, who has not recovered from adverse events due to a previously administered agent. 6)Has a known additional malignancy that is progressing or requires active treatment. 7)Has received a live vaccine within 30 days of planned start of study therapy. 8)Has a known history of Human Immunodeficiency Virus. 9)Has known active Hepatitis B or Hepatitis C. 10)Has known history of, or any evidence of active, non-infectious pneumonitis. 11)Has an active infection requiring systemic therapy. 12)Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 13)Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment. 14)Previous severe hypersensitivity to another monoclonal antibody 15)Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial,interfere with the subject's participation for the full duration of the trial,or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
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