FWD-1802

This is a phase I open-label dose escalation trial of FWD1802 as monotherapy and in combination with palbociclib in patients with ER+/HER2- unresectable locally advanced or metastatic breast cancer The goal of this clinical trial] is to learn about in ER+/HER2- BC participant population. The main questions it aims to answer are:
* Establish the recommended phase II dose (RP2D) and/or the maximum tolerated dose (MTD) of FWD1802 as monotherapy and in combination with palbociclib in patients with ER+/HER2- unresectable locally advanced or metastatic breast cancer.
* Explore the safety and tolerability of FWD1802 as monotherapy and in combination with Palbociclib.
* Characterise Pharmacokinetics of FWD1802 as monotherapy and in combination with palbociclib.
* Explore preliminary efficacy signals.

"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。"