PHASE I TRIAL OF HIGH DOSE INTERLEUKIN 2 WITH TNF RECEPTOR IGG CHIMERA

高剂量白细胞介素 2 与 TNF 受体 IGG 嵌合体的 I 期试验

• 批准号: 2784233
• 金额: $ 3.4万
• 依托单位: TUFTS MEDICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/2784233
• 关键词: antibody receptor; chimeric proteins; clinical research; clinical trial phase I; cytokine receptors; dosage; drug screening /evaluation; human subject; immunoglobulin G; immunoglobulin structure; interleukin 2; neoplasm /cancer immunotherapy; neoplasm /cancer pharmacology; tumor necrosis factor alpha

The objectives of this study are: To assess the safety of and determine the maximum tolerated dose of intravenous rhu (CHO) IL-1R in cancer patients. To measure the pharmacokinetic profile of intravenous rhu (CHO) IL-1R in cancer patients. To determine either the effective biologic dose (EBD) as defined by inhibition of IL-2-induced CRP release or the maximum tolerated dose (MTD) of rhu (CHO) IL-1R (administered up to a maximum of 55 mg/m2 in patients undergoing high dose IL-2 therapy).

本研究的目的是：评估安全性并确定 静脉注射rhu（CHO）IL-1 R治疗癌症的最大耐受剂量 患者 测定静脉注射rhu（CHO）的药代动力学特征 癌症患者的IL-1 R 为了确定有效的生物剂量 (EBD)如通过抑制IL-2诱导的CRP释放或最大 rhu（CHO）IL-1 R的耐受剂量（MTD）（最大给药剂量为 55 mg/m2）。