[Translation] A Phase I clinical study evaluating the safety, tolerability, pharmacokinetics, and efficacy of oral ZN-F-6418 capsules in patients with KRAS G12D-mutated advanced solid tumors.
研究目的
主要研究目的:
? 评价口服ZN-F-6418 胶囊单药在KRAS G12D 突变的晚期实体瘤受试者的安全性和耐受性;
? 探索口服ZN-F-6418 胶囊单药在KRAS G12D 突变的晚期实体瘤受试者中的最大耐受剂量(MTD),为后续临床试验推荐给药剂量提供依据。
次要研究目的:
? 评估口服ZN-F-6418 胶囊单药在KRAS G12D 突变的晚期实体瘤受试者中的药代动力学(PK)特征; ? 初步评估口服ZN-F-6418 胶囊单药在KRAS G12D 突变的晚期实体瘤的抗肿瘤疗效。
[Translation] Study Objectives
Primary Study Objectives:
? To evaluate the safety and tolerability of oral ZN-F-6418 capsules as monotherapy in subjects with KRAS G12D-mutant advanced solid tumors;
? To explore the maximum tolerated dose (MTD) of oral ZN-F-6418 capsules as monotherapy in subjects with KRAS G12D-mutant advanced solid tumors, providing a basis for recommending dosage in subsequent clinical trials.
Secondary Study Objectives:
? To evaluate the pharmacokinetic (PK) characteristics of oral ZN-F-6418 capsules as monotherapy in subjects with KRAS G12D-mutant advanced solid tumors;
? To preliminarily evaluate the antitumor efficacy of oral ZN-F-6418 capsules as monotherapy in subjects with KRAS G12D-mutant advanced solid tumors.