[Translation] A Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of PRJ1-3024 in patients with advanced solid tumors
主要目的
I期剂量递增研究
在复发/难治实体瘤患者中,确定最大耐受剂量(MTD)和II期临床推荐剂量(RP2D)
II期扩展研究
评估在RP2D剂量下的目标实体瘤组内,PRJ1-3024的抗肿瘤活性。
次要目的
I期和II期研究
· 评估PRJ1-3024单药的安全性和耐受;
· 获得PRJ1-3024和其代谢物M6作为单药的药代动力学(PK)特性;
· 评估PRJ1-3024单药的初步疗效;
· 评估PRJ1-3024单药的至缓解时间(TTR)和无进展生存期(PFS)(仅用于II期研究)
· 评估PRJ1-3024单药抗肿瘤作用相关的总缓解率(ORR)。
探索性目的
探索可能提示PRJ1-3024疗效的药效学生物标志物;
[Translation] main purpose
Phase I dose escalation study
In patients with relapsed/refractory solid tumors, determine the maximum tolerated dose (MTD) and recommended dose for phase II clinical practice (RP2D)
Phase II extension study
The antitumor activity of PRJ1-3024 was evaluated within the target solid tumor group at RP2D doses.
secondary purpose
Phase I and Phase II studies
· Assess the safety and tolerability of PRJ1-3024 as a single agent;
· To obtain the pharmacokinetic (PK) properties of PRJ1-3024 and its metabolite M6 as single agents;
· To evaluate the preliminary efficacy of PRJ1-3024 as a single agent;
· To evaluate time to response (TTR) and progression-free survival (PFS) of PRJ1-3024 monotherapy (for phase II studies only)
· To evaluate the overall response rate (ORR) associated with PRJ1-3024 single-agent antitumor effect.
exploratory purpose
Explore pharmacodynamic biomarkers that may suggest efficacy of PRJ1-3024;