[Translation] A dose-escalation, open-label, phase I/II study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BPI-361175 tablets in patients with advanced solid tumors
1、 Ia期剂量递增/ Ib期扩大入组研究
1) 主要目的:
评估BPI-361175片在晚期实体瘤中的安全性和耐受性;
确定II期临床试验推荐剂量(RP2D),初步制定合理的给药方案。
2)次要目的:
评价BPI-361175片在晚期实体瘤中的药代动力学特征;
初步评估BPI-361175片在EGFR C797S突变的晚期非小细胞肺癌(NSCLC)中的疗效;
评价肿瘤组织样本中生物标志物(EGFR C797S突变)与BPI-361175片疗效的关系。
2、 II期确证性研究
1) 主要目的
评估BPI-361175片在携带EGFR C797S突变晚期NSCLC中的客观缓解率(ORR)。
2) 次要目的
进一步评价BPI-361175片在携带EGFR C797S突变的晚期NSCLC中的安全性和耐受性;
评估BPI-361175片在携带EGFR C797S突变的晚期NSCLC中的疾病控制率(DCR)、无进展生存期(PFS)、缓解持续时间(DOR)、总生存期(OS)。
[Translation] 1. Phase Ia dose escalation/Phase Ib expansion study
1) Primary objective:
To evaluate the safety and tolerability of BPI-361175 tablets in advanced solid tumors;
To determine the recommended dose (RP2D) for Phase II clinical trials and preliminarily formulate a reasonable dosing regimen.
2) Secondary objectives:
To evaluate the pharmacokinetic characteristics of BPI-361175 tablets in advanced solid tumors;
To preliminarily evaluate the efficacy of BPI-361175 tablets in advanced non-small cell lung cancer (NSCLC) with EGFR C797S mutation;
To evaluate the relationship between biomarkers (EGFR C797S mutation) in tumor tissue samples and the efficacy of BPI-361175 tablets.
2. Phase II confirmatory study
1) Primary objective
To evaluate the objective response rate (ORR) of BPI-361175 tablets in advanced NSCLC with EGFR C797S mutation.
2) Secondary objectives
To further evaluate the safety and tolerability of BPI-361175 tablets in advanced NSCLC with EGFR C797S mutation;
To evaluate the disease control rate (DCR), progression-free survival (PFS), duration of response (DOR), and overall survival (OS) of BPI-361175 tablets in advanced NSCLC with EGFR C797S mutation.