A Study to Investigate the Safety, Tolerability, of APG-2575 as a Single Agent or in Combination for Breast Cancer

Active:	Yes
Cancer Type:	Breast Cancer	NCT ID:	NCT04946864
Trial Phases:	Phase I Phase II	Protocol IDs:	APG2575XU103 (primary) NCI-2021-11630
Eligibility:	18 - 99 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Ascentage Pharma Group Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT04946864

Summary

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

Objectives

The phase ?b 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 ? portion will be conducted based on Simon's Minimax two
stage design.

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