The phase Ⅰb is dose escalation of APG-2575 as a single agent or in combination with palbociclib. A standard 3+3 design will be used to determine the MTD of APG-2575 as single agent in patients with solid tumors and MTD and RP2D of APG-2575 in combination with palbociclib in patients with breast cancer (MTD-combo). The phase II portion is a signal seeking expansion of APG-2575 at RP2D in combination with palbociclib in patients with ER+/HER2- metastatic breast cancers who have progressed during or relapsed after CDK 4/6inhibitor therapy. The phase Ⅱ portion will be conducted based on Simon's Minimax two stage design.
This is a multi-center, open-label, phase Ib/II study of APG-2575 as a single agent in patients with advanced solid tumors or in combination with anti-cancer agents such as CDK 4/6 inhibitor palbociclib in patients with ER+/HER2- metastatic breast cancer (mBC) who have progressed or relapsed after first line therapy