[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of oral ZN-B-2262 alone or in combination with radiotherapy in patients with advanced solid tumors
Ia
主要目的
评估口服ZN-B-2262单药在晚期实体瘤患者中的安全性和耐受性,探索口服ZN-B-2262单药在晚期实体瘤患者中的最大耐受剂量(MTD)或最大给药剂量(MAD),为后续临床试验推荐给药剂量提供依据;
次要目的
评估口服ZN-B-2262片剂或混悬液后ZN-B-2262及其代谢产物在晚期实体瘤患者中的药代动力学特征;
初步评估口服ZN-B-2262单药在晚期实体瘤患者中的抗肿瘤疗效;
探索性目的
根据需要进行人体中代谢产物鉴定的研究。
Ib&Ic
主要目的
评估口服ZN-B-2262联合放疗在初诊或复发、适合单纯放疗的局部晚期头颈部肿瘤患者中的安全性和耐受性;
探索ZN-B-2262联合放疗在初诊或复发、适合单纯放疗的局部晚期头颈部肿瘤患者中的最大耐受剂量(MTD),为后续临床试验推荐给药剂量提供依据;
次要目的
评估ZN-B-2262联合放疗在初诊或复发、适合单纯放疗的局部晚期头颈部肿瘤患者中ZN-B-2262和主要代谢产物(如有)的药代动力学特征;
初步评估ZN-B-2262联合放疗在初诊或复发、适合单纯放疗的局部晚期头颈部肿瘤患者中的抗肿瘤疗效;
[Translation] Ia
Main purpose
To evaluate the safety and tolerability of oral ZN-B-2262 monotherapy in patients with advanced solid tumors, explore the maximum tolerated dose (MTD) or maximum dose (MAD) of oral ZN-B-2262 monotherapy in patients with advanced solid tumors, and provide a basis for the recommended dose in subsequent clinical trials;
Secondary purpose
To evaluate the pharmacokinetic characteristics of ZN-B-2262 and its metabolites in patients with advanced solid tumors after oral administration of ZN-B-2262 tablets or suspension;
To preliminarily evaluate the anti-tumor efficacy of oral ZN-B-2262 monotherapy in patients with advanced solid tumors;
Exploratory purpose
To conduct research on the identification of metabolites in humans as needed.
Ib&Ic
Main purpose
To evaluate the safety and tolerability of oral ZN-B-2262 combined with radiotherapy in patients with locally advanced head and neck tumors who are newly diagnosed or recurrent and suitable for radiotherapy alone;
To explore the maximum tolerated dose (MTD) of ZN-B-2262 combined with radiotherapy in patients with locally advanced head and neck tumors who are newly diagnosed or recurrent and suitable for radiotherapy alone, and to provide a basis for the recommended dosage in subsequent clinical trials;
Secondary purpose
To evaluate the pharmacokinetic characteristics of ZN-B-2262 and major metabolites (if any) in patients with locally advanced head and neck tumors who are newly diagnosed or recurrent and suitable for radiotherapy alone;
To preliminarily evaluate the anti-tumor efficacy of ZN-B-2262 combined with radiotherapy in patients with locally advanced head and neck tumors who are newly diagnosed or recurrent and suitable for radiotherapy alone;