[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of oral WJ01075 tablets in patients with advanced malignant solid tumors by dose escalation and dose expansion
剂量递增阶段(Ia期)
主要目的: 评估 WJ01075 片在晚期恶性实体瘤患者中的安全性和耐受性;
评估 WJ01075 片在晚期恶性实体瘤患者中的剂量限制性毒性(DLT)、最大耐受剂量(MTD),初步探索 II 期给药剂量(RP2D);
次要目的:
评估 WJ01075 片在晚期实体瘤患者中的药代动力学(PK)特征;
初步评估 WJ01075 片在晚期实体瘤患者中的有效性。
扩展阶段(Ib期)
Ib期研究计划进行多瘤种队列扩展研究,以进一步评估 WJ01075 片在晚期恶性实体瘤患者中的 PK 特征、安全性和初步有效性。
探索性目的(适用于各个阶段) 探索 WJ01075 片的暴露量/剂量与安全性以及临床疗效之间的关系;
探索 WJ01075 片的可能代谢途径:鉴定血浆中主要代谢产物。
[Translation] Dose escalation phase (Phase Ia)
Primary objectives: To evaluate the safety and tolerability of WJ01075 tablets in patients with advanced malignant solid tumors;
To evaluate the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of WJ01075 tablets in patients with advanced malignant solid tumors, and to preliminarily explore the Phase II dosing dose (RP2D);
Secondary objectives:
To evaluate the pharmacokinetic (PK) characteristics of WJ01075 tablets in patients with advanced solid tumors;
Preliminary evaluation of the efficacy of WJ01075 tablets in patients with advanced solid tumors.
Extension phase (Phase Ib)
The Phase Ib study plans to conduct a multi-tumor cohort expansion study to further evaluate the PK characteristics, safety and preliminary efficacy of WJ01075 tablets in patients with advanced malignant solid tumors.
Exploratory objectives (applicable to all phases) To explore the relationship between the exposure/dose of WJ01075 tablets and safety and clinical efficacy;
To explore the possible metabolic pathways of WJ01075 tablets: to identify the main metabolites in plasma.