PHASE I DOSE ESCALATION STUDY OF RECOMBINANT HUMAN INTERLEUKIN 12

重组人白细胞介素 12 的 I 期剂量递增研究

• 批准号: 3740317
• 负责人: MICHAEL B ATKINS
• 金额: --
• 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/3740317
• 关键词: antineoplastics; carcinoma; clinical trials; cytokine; dosage; drug administration routes; drug quality /standard; drug tolerance; human subject; human therapy evaluation; immunopharmacology; neoplasm /cancer immunotherapy; neoplasm /cancer pharmacology; recombinant proteins

The primary objective of this Phase I dose-escalating study of recombinant human interleukin-12 (rhIL-12) is to assess the safety and maximum tolerated dose of rhIL-12 when administered by subcutaneous injection in patients with cancer. The secondary objectives are to determine the immunopharmacologic profile of rhIL-12; to explore the antitumor efficacy of the dosing schedule and route of administration; and, in selected patients, to evaluate the serum of concentrations of rhIL-12 administered as a subcutaneous injection.

这项I期剂量递增研究的主要目标是 重组人白介素12(rhIL-12)用于评价其安全性和安全性 皮下注射重组人白介素12的最大耐受量 为癌症患者注射。次要目标是 测定重组人白介素12的免疫药理学特性 给药程序和给药途径的抗肿瘤效果； 并且，在选定的患者中，评估血清中的 皮下注射重组人白介素12。