[Translation] An open-label, dose-escalation and expansion Phase I/IIa clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of ZX-101A monotherapy in patients with advanced solid tumors
1.单药剂量递增(Part 1)
主要目的:
评价ZX-101A在晚期实体瘤患者中的安全性及耐受性,并确定最大耐受剂量(MTD)或最佳生物给药剂量(OBD)、Ⅱ期临床研究推荐剂量(RP2D)。
次要目的:
评价ZX-101A在晚期实体瘤患者中的药代动力学(PK)特征;
初步评估ZX-101A在晚期实体瘤患者中的抗肿瘤活性,为后续临床试验提供剂量依据。
探索性目的:
探索ZX-101A在晚期实体瘤患者中的药效学(PD)特征。
2.单药扩展(Part 2)
主要目的:
评价ZX-101A在晚期实体瘤患者中的安全性及耐受性。
次要目的:
评价ZX-101A在晚期实体瘤患者中的PK特征;
评价ZX-101A在晚期实体瘤患者中的抗肿瘤活性,为后续临床试验提供剂量依据。
探索性目的:
探索ZX-101A在晚期实体瘤患者中的PD特征;
探索ZX-101A对血清中免疫细胞因子的影响。
[Translation] 1. Single-drug dose escalation (Part 1)
Main purpose:
Evaluate the safety and tolerability of ZX-101A in patients with advanced solid tumors, and determine the maximum tolerated dose (MTD) or optimal biological administration dose (OBD), and the recommended dose for phase II clinical studies (RP2D).
Secondary purpose:
Evaluate the pharmacokinetic (PK) characteristics of ZX-101A in patients with advanced solid tumors;
Preliminary evaluation of the anti-tumor activity of ZX-101A in patients with advanced solid tumors, and provide a dose basis for subsequent clinical trials.
Exploratory purpose:
Explore the pharmacodynamic (PD) characteristics of ZX-101A in patients with advanced solid tumors.
2. Single-drug expansion (Part 2)
Main purpose:
Evaluate the safety and tolerability of ZX-101A in patients with advanced solid tumors.
Secondary purpose:
Evaluate the PK characteristics of ZX-101A in patients with advanced solid tumors;
Evaluate the anti-tumor activity of ZX-101A in patients with advanced solid tumors, and provide a dose basis for subsequent clinical trials.
Exploratory purpose:
To explore the PD characteristics of ZX-101A in patients with advanced solid tumors;
To explore the effect of ZX-101A on immune cytokines in serum.