[Translation] An open-label, dose-escalation, and dose-expansion phase I clinical study of the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of AND019 in patients with advanced/metastatic estrogen receptor-positive (ER+) human epidermal growth factor receptor 2-negative (HER2-) breast cancer
主要目的:
评估AND019在ER+/HER2-乳腺癌受试者中的安全性和耐受性;
评估AND019在ER+/HER2-乳腺癌受试者中的药代动力学特征。
次要目的:
确定AND019在ER+/HER2-乳腺癌受试者中的二期推荐剂量(Recommended Phase 2 Dose, RP2D);
评估AND019在ER+/HER2-乳腺癌受试者中的初步疗效。
探索性目的:
评估AND019在ER+/HER2-乳腺癌受试者中的无进展生存期(progression free survival,PFS);
初步评估治疗前和治疗后肿瘤组织和外周血中与疗效及耐药相关的药效动力学(Pharmacodynamics, PD)/生物标志物。
[Translation] Primary objectives:
To evaluate the safety and tolerability of AND019 in subjects with ER+/HER2- breast cancer;
To evaluate the pharmacokinetic characteristics of AND019 in subjects with ER+/HER2- breast cancer.
Secondary objectives:
To determine the recommended Phase 2 dose (RP2D) of AND019 in subjects with ER+/HER2- breast cancer;
To evaluate the preliminary efficacy of AND019 in subjects with ER+/HER2- breast cancer.
Exploratory objectives:
To evaluate the progression free survival (PFS) of AND019 in subjects with ER+/HER2- breast cancer;
To preliminarily evaluate the pharmacodynamics (PD)/biomarkers related to efficacy and resistance in tumor tissues and peripheral blood before and after treatment.