Open-Label Multicenter 2-Arm Phase I Study of RO5429083 With Dose-Escalation and Extension Cohorts, and Imaging Cohorts With RO5429083 and 89Zr-labeled RO5429083, in Patients With Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 65
- 主要终点
- Arm A: Safety (Incidence of adverse events related to study drug)
研究概览
简要总结
This open-label 2-arm study will assess the pharmacokinetics, pharmacodynamics, safety and efficacy of RO5429083 in patients with metastatic and/or locally advanced CD44-expressing malignant solid tumors. In Part A, cohorts of patients will receive RO5429083 intravenously at escalating doses. In Part B, patients will receive 89Zr-labelled RO5429083 in Cycles 1 and/or 2, followed by RO5429083. For all patients there will be an option to continue treatment with RO5429083 until disease progression or unacceptable toxicity occurs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Adult patients, >/= 18 years of age
- •Metastatic and/or locally advanced malignant CD44-expressing solid tumors
- •Patients with disease progression on standard therapy, or have tumors that are not curable by standard therapy
- •Life expectancy of over 12 weeks
排除标准
- •Concurrent therapy with any other investigational drug
- •Known or suspected CNS metastases including leptomeningeal metastases
- •Active bleeding, bleeding diathesis or history of coagulation disorder
- •Uncontrolled diabetes mellitus
- •Active or uncontrolled infections
- •Patients with HIV infections
研究组 & 干预措施
A
干预措施: RO5429083 (Drug)
B
干预措施: RO5429083 (Drug)
结局指标
主要结局
Arm A: Safety (Incidence of adverse events related to study drug)
时间窗: Until disease progression or unacceptable toxicity (approximately 2 years)
Arm A: Maximum tolerated dose of RO5429083
时间窗: Until disease progression or unacceptable toxicity (approximately 2 years)
Arm B: Tissue distribution of RO5429083 assessed by positron emission tomography (PET)
时间窗: Until disease progression or unacceptable toxicity (approximately 2 years)
Arm A: Tumor Growth Control Rate
时间窗: Until disease progression or unacceptable toxicity (approximately 2 years)
Arm A: Pharmacokinetics (serum levels of RO5429083)
时间窗: Until disease progression or unacceptable toxicity (approximately 2 years)
次要结局
- Arm A: Recommended dose of RO5429083 for the extension cohort(Until disease progression or unacceptable toxicity (approximately 2 years))
- Arm A: Anti-tumor activity of RO5429083(Until disease progression or unacceptable toxicity (approximately 2 years))
- Arm B: Target saturation of 89Zr-labelled RO5429083(Until disease progression or unacceptable toxicity (approximately 2 years))