A Phase I, Multicenter, Open-Label, Dose-Escalation, Multidose Study of MDX-1203 in Subjects With Advanced/Recurrent Clear Cell Renal Cell Carcinoma or Relapsed/Refractory B-Cell Non Hodgkin's Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 5
- 主要终点
- Safety profile of MDX-1203 and determine the maximum tolerated dose (MTD)
研究概览
简要总结
The purpose of this study is to determine if MDX-1203 is safe for the treatment of renal cell carcinoma or non-hodgkin's lymphoma.
详细描述
Multicenter, open-label, dose-escalation, multidose study of MDX-1203, a fully human monoclonal antibody drug conjugate targeting the CD70 transmembrane cell-surface protein which is highly expressed in ccRCC and B-NHL. MDX-1203 is composed of a human anti-CD70 monoclonal antibody covalently linked to a prodrug form of a cytotoxic deoxyribonucleic acid (DNA) minor-groove binding agent (MGBA).
The study will consist of 3 periods: Screening (up to 28 days), Treatment (up to 17 cycles or 2 years), and Follow-up (up to 6 months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- •Criteria specific to each tumor type:
- •For Clear cell renal cell carcinoma (ccRCC): advanced or recurrent disease. Must have failed at least 1 prior systemic therapy
- •For B-cell non-Hodgkin's lymphoma (B-NHL): Must have failed at least 1 prior systemic therapy
- •Measurable disease criteria by tumor type:
- •For ccRCC: At least 1 unidimensional measurable lesion
- •For B-NHL: At least 1 bidimensionally measurable lesion
- •Prior therapies for advanced/recurrent ccRCC or relapsed/refractory B-NHL or have become intolerant to a systemic therapy
- •Provide archived or fresh tumor tissue for CD70 status. Subjects must be CD70+
- •Provision of fresh tissue (pre-treatment and on-treatment) for exploratory analysis is mandatory for at least 5 and a maximum of 10 B-NHL subjects
排除标准
- •Prior therapy with an anti-CD70 antibody
- •History of severe hypersensitivity reactions to other monoclonal antibodies
- •Active or untreated central nervous system lymphoma
- •Active infection (viral, bacterial, or fungal)
- •Evidence of bleeding diathesis or coagulopathy
- •Active autoimmune disease requiring immunosuppressive therapy
- •Known current drug or alcohol abuse
研究组 & 干预措施
MDX-1203
Accelerated titration design (ATD)of 6 dose levels. Subjects will be assigned to a dose level in the order they enter the study
干预措施: MDX-1203 (Biological)
结局指标
主要结局
Safety profile of MDX-1203 and determine the maximum tolerated dose (MTD)
时间窗: up to 17 cycles
次要结局
- Biomarker: Incidence of CD70+ tumors in target population(Screening)