[Translation] A multicenter, open-label phase I/II clinical study of the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of HBW-012462 tablets in Chinese patients with locally advanced or metastatic solid tumors carrying KRAS mutations.
第1部分:剂量递增阶段和PK扩展阶段(I期)
(1)主要目的
●评价HBW-012462 在携带KRAS突变的局部晚期或转移性实体瘤患者中的安全性和耐受性,探索HBW-012462的MTD,为Ⅱ期临床研究推荐合理的给药方案(RP2D)。
(2)次要目的
●评价HBW-012462 在携带KRAS突变的局部晚期或转移性实体瘤患者中的PK特征;
●评价HBW-012462在携带KRAS突变的局部晚期或转移性实体瘤患者中的初步抗肿瘤
疗效。
第2部分:剂量扩展阶段(Ⅱ期)
(1)主要目的
●评价HBW-012462在携带KRAS突变的局部晚期或转移性实体瘤患者中的客观缓解率(ORR)。
(2)次要目的
●评价HBW-012462 在携带KRAS突变的局部晚期或转移性实体瘤患者中的其它有效性指标;
●评价HBW-012462 在携带KRAS突变的局部晚期或转移性实体瘤患者中的安全性;
●评价HBW-012462 在携带KRAS突变的局部晚期或转移性实体瘤患者中的PK特征。
[Translation] Part 1: Dose Escalation and PK Expansion Phase (Phase I)
(1) Primary Objective
●Evaluate the safety and tolerability of HBW-012462 in patients with locally advanced or metastatic solid tumors harboring KRAS mutations, explore the MTD of HBW-012462, and recommend a reasonable dosing regimen (RP2D) for the Phase II clinical trial.
(2) Secondary Objectives
●Evaluate the PK characteristics of HBW-012462 in patients with locally advanced or metastatic solid tumors harboring KRAS mutations;
●Evaluate the preliminary antitumor efficacy of HBW-012462 in patients with locally advanced or metastatic solid tumors harboring KRAS mutations.
Part 2: Dose Expansion Phase (Phase II)
(1) Primary Objective
●Evaluate the objective response rate (ORR) of HBW-012462 in patients with locally advanced or metastatic solid tumors harboring KRAS mutations. (2) Secondary Objectives
●Evaluate other efficacy endpoints of HBW-012462 in patients with locally advanced or metastatic solid tumors carrying KRAS mutations;
●Evaluate the safety of HBW-012462 in patients with locally advanced or metastatic solid tumors carrying KRAS mutations;
●Evaluate the PK characteristics of HBW-012462 in patients with locally advanced or metastatic solid tumors carrying KRAS mutations.