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R01 治疗晚期实体瘤的安全耐受性和药代动力学的 I 期临床研究
[Translation] Phase I clinical study on the safety, tolerability and pharmacokinetics of R01 in the treatment of advanced solid tumors
Ia 期剂量递增阶段:主要目的:1. 评价R01治疗晚期实体瘤患者的耐受性和安全性,探索限制性毒性反应剂量以及最大耐受剂量。
次要目的:1.评价R01治疗晚期实体瘤患者的药代动力学特征;2.评价R01治疗晚期实体瘤患者的初步疗效,探索Ib期临床试验推荐剂量和给药方式
Ib 期剂量扩展阶段:主要目的:1. 评价R01不同起效剂量及给药方式治疗晚期实体瘤患者的安全性。次要目的:1 进一步评价R01治疗晚期实体瘤患者的药代动力学特征;2.评价R01治疗晚期实体瘤患者的初步疗效,确定II期临床试验推荐剂量和给药方式。
[Translation] Phase Ia dose escalation phase: Main purpose: 1. Evaluate the tolerability and safety of R01 in the treatment of patients with advanced solid tumors, and explore the limiting toxicity dose and the maximum tolerated dose.
Secondary purpose: 1. Evaluate the pharmacokinetic characteristics of R01 in the treatment of patients with advanced solid tumors; 2. Evaluate the preliminary efficacy of R01 in the treatment of patients with advanced solid tumors, and explore the recommended dose and administration method for Phase Ib clinical trials
Phase Ib dose expansion phase: Main purpose: 1. Evaluate the safety of R01 in the treatment of patients with advanced solid tumors at different effective doses and administration methods. Secondary purpose: 1 Further evaluate the pharmacokinetic characteristics of R01 in the treatment of patients with advanced solid tumors; 2. Evaluate the preliminary efficacy of R01 in the treatment of patients with advanced solid tumors, and determine the recommended dose and administration method for Phase II clinical trials.
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