An Open Label, Dose-escalation Study to Evaluate Safety, Pharmacokinetics and Tumor Growth Control Rate of RO5083945, a Glycoengineered Antibody Against EGFR, in Patients With Metastatic and/or Locally Advanced Malignant EGFR+ Solid Tumors.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 102
- 主要终点
- Pharmacokinetic parameters, and maximum tolerated dose (Part 1)
研究概览
简要总结
This study will evaluate the pharmacokinetics, maximum tolerated dose and anti-tumor activity of RO5083945 in patients with metastatic and/or locally advanced malignant EGFR+ solid tumors. In the first part of the study, groups of patients will be sequentially enrolled to receive ascending doses of RO5083945 administered weekly, every 2 weeks or every 3 weeks. The starting dose of 50mg weekly will be escalated in subsequent groups of patients after a successful assessment of the safety, tolerability and pharmacokinetics of the previous dose. In Part 2 of the study, patients with EGFR+ and mutant KRAS colorectal cancer will be enrolled, and will receive RO5083945 at the recommended dose and regimen identified in Part 1. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
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
- •adult patients, >=18 years of age;
- •centrally confirmed EGFR expression in tumor tissue;
- •radiologically measurable or clinically evaluable disease;
- •last dose of systemic anti-neoplastic therapy or radiotherapy >=28 days prior to start of study;
- •histologically or cytologically confirmed advanced stage, primary or metastatic EGFR+ solid tumors (Part 1);
- •histologically or cytologically confirmed advanced stage, primary or metastatic EGFR+ and mutant KRAS colorectal cancer (Part 2);
- •not more than 2 previous cytotoxic regimens for metastatic disease (Part 2).
排除标准
- •history of grade 3-4 toxicity resulting from previous anti-EGFR treatment;
- •known or suspected CNS metastases;
- •wild type KRAS colorectal cancer (Part 2).
研究组 & 干预措施
1
干预措施: RO5083945 (Drug)
结局指标
主要结局
Pharmacokinetic parameters, and maximum tolerated dose (Part 1)
时间窗: Throughout study
Tumor growth control rate (CR, PR, SD) (Part 2)
时间窗: Event driven
次要结局
- AEs and laboratory parameters, pharmacodynamic parameters (Parts 1 and 2)(Throughout study)
- Anti-tumor activity (ORR, DR, PFS) (Part 2)(Event driven)