[Translation] A dose-escalation, dose-expansion, open-label Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of PR00012 in patients with solid tumors who have failed or are intolerant to standard treatment or have no standard treatment
主要研究目的:
1、评估PR00012在经标准治疗失败或不耐受或无标准疗法的实体瘤患者中的安全性、耐受性。
2、确定PR00012在经标准治疗失败或不耐受或无标准疗法的实体瘤患者中的最大耐受剂量和扩展期推荐剂量。
3、确定PR00012 II期临床研究推荐剂量。
次要研究目的:
1、评估PR00012在经标准治疗失败或不耐受或无标准疗法的实体瘤患者中的药代动力学特征。
2、评估PR00012在经标准治疗失败或不耐受或无标准疗法的实体瘤患者中的初步抗肿瘤活性。
[Translation] Main study objectives:
1. To evaluate the safety and tolerability of PR00012 in patients with solid tumors who have failed or are intolerant to standard treatment or have no standard treatment.
2. To determine the maximum tolerated dose and recommended dose for the extension phase of PR00012 in patients with solid tumors who have failed or are intolerant to standard treatment or have no standard treatment.
3. To determine the recommended dose for the Phase II clinical study of PR00012.
Secondary study objectives:
1. To evaluate the pharmacokinetic characteristics of PR00012 in patients with solid tumors who have failed or are intolerant to standard treatment or have no standard treatment.
2. To evaluate the preliminary anti-tumor activity of PR00012 in patients with solid tumors who have failed or are intolerant to standard treatment or have no standard treatment.