[Translation] A multicenter, open-label phase I/II clinical study of the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of HBW-012462 tablets in patients with locally advanced or metastatic lung cancer and other solid tumors harboring 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
1)评价HBW-012462在携带KRAS突变的局部晚期或转移性肺癌和其他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
1)评价HBW-012462在携带KRAS突变的局部晚期或转移性肺癌和其他实体瘤患者中的PK特征;
2)评价HBW-012462在携带KRAS突变的局部晚期或转移性肺癌和其他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
1)评价HBW-012462在携带KRAS突变的局部晚期或转移性肺癌患者中的客观缓解率(ORR)。
(2)次要目的:
1)评价HBW-012462在携带KRAS突变的局部晚期或转移性肺癌患者中的其它有效性指标;
2)评价HBW-012462在携带KRAS突变的局部晚期或转移性肺癌患者中的安全性;
3)评价HBW-012462在携带KRAS突变的局部晚期或转移性肺癌患者中的PK特征。
[Translation] Part 1: Dose Escalation and PK Expansion Phase (Phase I)
(1) Primary Objectives
1) To evaluate the safety and tolerability of HBW-012462 in patients with locally advanced or metastatic lung cancer and other solid tumors carrying KRAS mutations, to explore the MTD of HBW-012462, and to recommend a reasonable dosing regimen (RP2D) for the Phase II clinical trial.
(2) Secondary Objectives
1) To evaluate the PK characteristics of HBW-012462 in patients with locally advanced or metastatic lung cancer and other solid tumors carrying KRAS mutations;
2) To evaluate the preliminary antitumor efficacy of HBW-012462 in patients with locally advanced or metastatic lung cancer and other solid tumors carrying KRAS mutations.
Part 2: Dose Expansion Phase (Phase II)
(1) Primary Objectives
1) To evaluate the objective response rate (ORR) of HBW-012462 in patients with locally advanced or metastatic lung cancer carrying KRAS mutations. (2) Secondary objectives:
1) To evaluate other efficacy endpoints of HBW-012462 in patients with locally advanced or metastatic lung cancer carrying KRAS mutations;
2) To evaluate the safety of HBW-012462 in patients with locally advanced or metastatic lung cancer carrying KRAS mutations;
3) To evaluate the pharmacokinetic characteristics of HBW-012462 in patients with locally advanced or metastatic lung cancer carrying KRAS mutations.