[Translation] An open-label, dose-escalation, dose-expansion Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor efficacy of oral FWD1802 monotherapy and in combination with palbociclib in subjects with ER+/HER2- unresectable locally advanced or metastatic breast cancer
"主要研究目的:
? 确定FWD1802单药治疗和与哌柏西利联合治疗ER+/HER2-不可切除的局部晚期或转移性乳腺癌受试者的II期推荐剂量(Recommended Phase II dose,RP2D)和/或最大耐受剂量(Maximum tolerated dose,MTD)。
? 探索FWD1802单药治疗和与哌柏西利联合治疗的安全性和耐受性。
次要研究目的:
? 评价FWD1802单药治疗和与哌柏西利联合治疗的药代动力学特征。
? 探索FWD1802在人体内的代谢途径。
? 探索初步疗效。
探索性目的:
? FWD1802单药治疗和与哌柏西利联合治疗的生物标记物。"
[Translation] "Main study objectives:
? To determine the recommended Phase II dose (RP2D) and/or maximum tolerated dose (MTD) of FWD1802 monotherapy and in combination with palbociclib for subjects with ER+/HER2- unresectable locally advanced or metastatic breast cancer.
? To explore the safety and tolerability of FWD1802 monotherapy and in combination with palbociclib.
Secondary study objectives:
? To evaluate the pharmacokinetic characteristics of FWD1802 monotherapy and in combination with palbociclib.
? To explore the metabolic pathway of FWD1802 in humans.
? To explore the preliminary efficacy.
Exploratory objectives:
? Biomarkers of FWD1802 monotherapy and in combination with palbociclib."