[Translation] Study on the safety, tolerability and pharmacokinetic characteristics of KMHH-03 for injection in subjects with advanced breast cancer
主要目的:
(1) 评价注射用KMHH-03在晚期乳腺癌受试者中的安全性及耐受性;
(2) 确定注射用KMHH-03单次给药的剂量限制性毒性(DLT)与最大耐受剂量(MTD)。
次要目的:
(1) 评价注射用KMHH-03在晚期乳腺癌受试者中的药代动力学(PK)特征;
(2) 评估注射用KMHH-03在晚期乳腺癌受试者中的免疫原性;
(3) 观察注射用KMHH-03在晚期乳腺癌受试者中的初步疗效,为后续临床试验推荐剂量和给药方案提供依据。
[Translation] Primary objectives:
(1) To evaluate the safety and tolerability of KMHH-03 for injection in subjects with advanced breast cancer;
(2) To determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of a single dose of KMHH-03 for injection.
Secondary objectives:
(1) To evaluate the pharmacokinetic (PK) characteristics of KMHH-03 for injection in subjects with advanced breast cancer;
(2) To evaluate the immunogenicity of KMHH-03 for injection in subjects with advanced breast cancer;
(3) To observe the preliminary efficacy of KMHH-03 for injection in subjects with advanced breast cancer and provide a basis for the recommended dose and dosing regimen for subsequent clinical trials.