[Translation] A multicenter, open-label, phase I/II clinical study of the safety, tolerability, preliminary efficacy, and pharmacokinetic characteristics of HBW-012336 capsules in Chinese patients with locally advanced or metastatic solid tumors carrying KRAS G12D mutations
主要目的:
(1)评价HBW-012336在携带KRAS G12D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-012336的MTD,为Ⅱ期临床研究推荐合理的给药方案(RP2D)。
次要目的:
(1)评价HBW-012336在携带KRAS G12D突变的局部晚期或转移性实体瘤患者中的PK特征;
(2)初步评价HBW-012336在携带KRAS G12D突变的局部晚期或转移性实体瘤患者中的抗肿瘤疗效。
[Translation] Primary objectives:
(1) To evaluate the safety and tolerability of HBW-012336 in patients with locally advanced or metastatic solid tumors carrying KRAS G12D mutations, explore the MTD of HBW-012336, and recommend a reasonable dosing regimen (RP2D) for Phase II clinical studies.
Secondary objectives:
(1) To evaluate the PK characteristics of HBW-012336 in patients with locally advanced or metastatic solid tumors carrying KRAS G12D mutations;
(2) To preliminarily evaluate the anti-tumor efficacy of HBW-012336 in patients with locally advanced or metastatic solid tumors carrying KRAS G12D mutations.