NCT01383733已完成1 期
A Phase I Multiple Ascending Dose (MAD) Study of RO5458640, a Humanized Monoclonal Antibody Against the TNF-like Weak Inducer of Apoptosis (TWEAK) Ligand, in Patients With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 主要终点
- Safety: Incidence of adverse events
研究概览
简要总结
This multicenter, open-label, multiple ascending dose study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RO5458640 in patients with advanced solid tumors. Cohorts of patients will receive ascending doses of RO5458640 intravenously, either weekly or every 2 weeks or every 3 weeks, 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
- 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
- •Histologically or cytologically confirmed malignant solid tumors
- •Measurable and/or evaluable disease according to RECIST 1.1 criteria
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Adequate bone marrow, liver and renal function
排除标准
- •Prior chemotherapy, radiotherapy, or hormonal therapy for cancer within 3 weeks of first study treatment, except for short course palliative radiotherapy for pain
- •Antibody therapy or other immunotherapy currently or less than 21 days prior to study treatment
- •Current immunosuppressive therapy, including those prescribed for organ transplantation and rheumatologic disease
- •Corticoid therapy > 10 mg/day prednisone or equivalent
- •Patients who have not recovered from > grade 1 (NCI CTCAE) prior adverse events from any cancer therapy, except for alopecia
- •Pregnant or breastfeeding women
- •Known hypersensitivity to any component of RO5458640 or previous severe hypersensitivity reactions to monoclonal antibody therapy
- •History of active seizure disorder
- •History of CNS or leptomeningeal metastases, except for clinically stable disease for at least 3 weeks prior to first study drug
- •Cardiovascular illness: CVA or MI < 6 months prior to study, CHF > NYHA Class 2, QTcF >480 msec.
- •Active infection
研究组 & 干预措施
Single Arm
Experimental
干预措施: RO5458640 (Drug)
结局指标
主要结局
Safety: Incidence of adverse events
时间窗: approximately 2 years
Dose Limiting Toxicity (DLT) according to CTEP Common Terminology Criteria for Adverse Events Version 4.0
时间窗: approximately 2 years
Maximum Tolerated Dose (MTD)
时间窗: approximately 2 years
次要结局
- Tumor response according to RECIST criteria(approximately 2 years)
- Pharmacokinetics: area under the concentration - time curve (AUC) on two administration schedules(approximately 2 years)
- Antigenicity: Human anti-human antibody [HAHA] profile(approximately 2 years)
研究者
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