[Translation] Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of XNW29016 tablets in advanced solid tumors that have failed standard treatment
I期研究目的
主要目的: 评价XNW29016片在标准治疗失败的晚期实体瘤受试者中的安全性和耐受性,并确定XNW29016片的最大耐受剂量(MTD),以及II期临床研究推荐剂量(RP2D)。
次要目的:
评价XNW29016片及其代谢产物在标准治疗失败的晚期实体瘤受试者中的药代动力学(PK)特征;
评价XNW29016片在标准治疗失败的晚期实体瘤受试者中的药效动力学(PD)特征;
评价XNW29016片治疗标准治疗失败的晚期实体瘤受试者的初步疗效。
探索性目的:
分析BRCA1/2等HRR通路基因、HRD等生物标志物与疗效的相关性。
II期研究目的
主要目的:
评价XNW29016片在目标适应症受试者中的抗肿瘤疗效。
次要目的:
评价XNW29016片在目标适应症受试者中的安全性和耐受性;
评价XNW29016片及其代谢产物在目标适应症受试者中的PK特征。
探索性目的:
分析BRCA1/2等HRR通路基因、HRD等生物标志物与疗效的相关性。
[Translation] Objectives of Phase I Study
Main Objective: To evaluate the safety and tolerability of XNW29016 tablets in subjects with advanced solid tumors who have failed standard treatment, and to determine the maximum tolerated dose (MTD) of XNW29016 tablets, as well as the recommended dose (RP2D) for Phase II clinical studies.
Secondary Objectives:
To evaluate the pharmacokinetic (PK) characteristics of XNW29016 tablets and its metabolites in subjects with advanced solid tumors who have failed standard treatment;
To evaluate the pharmacodynamic (PD) characteristics of XNW29016 tablets in subjects with advanced solid tumors who have failed standard treatment;
To evaluate the preliminary efficacy of XNW29016 tablets in the treatment of subjects with advanced solid tumors who have failed standard treatment.
Exploratory Objectives:
To analyze the correlation between HRR pathway genes such as BRCA1/2, biomarkers such as HRD and efficacy.
Purpose of Phase II Study
Main Objective:
To evaluate the anti-tumor efficacy of XNW29016 tablets in subjects with target indications.
Secondary purpose:
To evaluate the safety and tolerability of XNW29016 tablets in subjects with target indications;
To evaluate the PK characteristics of XNW29016 tablets and its metabolites in subjects with target indications.
Exploratory purpose:
To analyze the correlation between HRR pathway genes such as BRCA1/2 and biomarkers such as HRD and efficacy.