A Phase I, Multicenter, Open-label Study of LFA102 Administered Intravenously in Japanese Patients With Castration-resistant Prostate Cancer or Advanced Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicities (DLT)
研究概览
简要总结
This study will evaluate safety and tolerability to determine the MTD/RD.
详细描述
This is a phase I open-label, multi-center, dose escalation study in Japanese patients with CRPC or advanced BC. LFA102 will be administered intravenously once every 4 weeks during the study. All patients will remain on treatment until they meet the criteria for study discontinuation (e.g. disease progression, unacceptable toxicity, patient withdrawal) or study closure.
This study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of LFA102. Each cohort will enroll a minimum of 3 patients. A two-parameter Bayesian logistic regression model employing the escalation with overdose control principle will be used during the escalation phase for dose level selection and for determination of the MTD or RD.
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
- •Histologically confirmed diagnosis of prostate cancer
- •Histologically or cytologically confirmed locally advanced or metastatic breast cancer
排除标准
- •Patients with untreated and/or symptomatic metastatic CNS disease
- •Prior anaphylactic or other severe infusion reaction
- •Treatment with agent which affect prolactin levels
- •Active autoimmune disease
- •Other protcol-defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
LFA102
干预措施: LFA102 (Drug)
结局指标
主要结局
Dose Limiting Toxicities (DLT)
时间窗: 1st treatment cycle (28 days)
Frequency and severity of dose limiting toxicities (DLTs)
次要结局
- Objective Response Rate(every 8 week or 12 weeks, until disase progression)
- Frequency, duration and severity of Adverse Events (AEs)(at informed consent, until 28 days after treatment discontinuation)
- Antibodies against LFA102(day 1 of each treatment cycle until disease progression)
- Serum Concentration(cycle 1 day 1 until disease progression)
- Progression Free Survival(every 8 or 12 weeks until disease progression)
- PK parameters(cycle 1 day 1 until disease progression)