[Translation] A two-stage, multicenter, open-label Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BEBT-607 in patients with advanced or metastatic solid tumors with KRAS G12C mutations
Ia期剂量递增阶段:
主要目的:评价BEBT-607治疗伴有KRAS G12C突变的晚期或转移性实体瘤患者的耐受性和安全性,探索最大耐受剂量(MTD)和扩展推荐剂量(RDE)。次要目的:评价BEBT-607在伴有KRAS G12C突变的晚期或转移性实体瘤患者中的药代动力学特征;评价BEBT-607治疗伴有KRAS G12C突变的晚期或转移性实体瘤的初步疗效;
Ib期剂量扩展阶段:
主要目的:评价BEBT-607在RDE下治疗伴有KRAS G12C突变的晚期或转移性实体瘤患者的初步疗效,确定 II 期临床推荐剂量(RP2D)。次要目的:评价BEBT-607在RDE下治疗伴有KRAS G12C突变的晚期或转移性实体瘤患者中的安全性;进一步评价在RDE下,BEBT-607在伴有KRAS G12C突变的晚期或转移性实体瘤患者中的药代动力学特征。
[Translation] Phase Ia dose escalation phase:
Primary purpose: To evaluate the tolerability and safety of BEBT-607 in the treatment of patients with advanced or metastatic solid tumors with KRAS G12C mutations, and to explore the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE). Secondary purpose: To evaluate the pharmacokinetic characteristics of BEBT-607 in patients with advanced or metastatic solid tumors with KRAS G12C mutations; To evaluate the preliminary efficacy of BEBT-607 in the treatment of advanced or metastatic solid tumors with KRAS G12C mutations;
Phase Ib dose expansion phase:
Primary purpose: To evaluate the preliminary efficacy of BEBT-607 in the treatment of patients with advanced or metastatic solid tumors with KRAS G12C mutations under RDE, and to determine the recommended dose (RP2D) for Phase II clinical trials. Secondary objectives: To evaluate the safety of BEBT-607 in the treatment of patients with advanced or metastatic solid tumors with KRAS G12C mutations under RDE; to further evaluate the pharmacokinetic characteristics of BEBT-607 in patients with advanced or metastatic solid tumors with KRAS G12C mutations under RDE.