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临床试验/NCT00836888
NCT00836888已完成1 期

ONO-4538 Phase I Study - A Single Center, Open Label, Dose Escalation Single Dose, Followed by Multiple Dose Study of ONO-4538, a Fully Human mAb to PD-1, in Patients With Advanced Malignant Solid Tumors

Ono Pharmaceutical Co. Ltd1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
17
试验地点
1
主要终点
Cmax at Single Dose

研究概览

简要总结

Evaluation of the safety, tolerability and pharmacokinetics (PK) of a single dose and multiple doses of ONO-4538 in Japanese patients with advanced malignant solid tumors, and exploratory evaluation of the pharmacological effect and efficacy of ONO-4538.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Histological or cytological diagnosis of solid tumor with at least one measurable lesion of ≥ 10mm.
  • Tumor must be advanced or recurrent which is refractory to standard therapies or for which no alternative, appropriate therapy exists.
  • ECOG Performance Status of 0-1
  • Life expectancy ≥ 3 months
  • Other inclusion criteria as specified in the study protocol

排除标准

  • History of severe hypersensitivity reactions to other antibodies.
  • Residual adverse reactions or effect of prior therapy, which deemed to affect the safety evaluation of the study drug by the investigator or subinvestigator.
  • Two or more synchronous tumors, except for adequately treated basal cell cancer or cancer in situ, or superficial bladder cancer, or any other cancers from which the patient has been disease-free for at least 5 years.
  • Patients with any active autoimmune disease or a documented history of chronic or recurrent autoimmune disease, or current medical condition that requires systemic immunosuppressive doses of steroids or other immunosuppressive medications.
  • Other exclusion criteria as specified in the study protocol

结局指标

主要结局

Cmax at Single Dose

时间窗: day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation

AUClast at Single Dose

时间窗: day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation

Ceoi at Multiple Doses

时间窗: day 15

Ceoi:Serum concentrations immediately after the end of continuous administration

T1/2 at Single Dose

时间窗: day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation

次要结局

  • Best Overall Response(up to study completion, every 4 weeks in principle)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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