NCT04946864

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

A Phase Ib/II Study to Investigate the Safety, Tolerability, of APG-2575 as a Single Agent or in Combination With Systemic Anti-cancer Agents in Patients With ER Positive Breast Cancer or Advanced Solid Tumors.

• Status: Suspended
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Ascentage Pharma Group Inc. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Breast Cancer
• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	APG-2575	APG2575 monotherapy
DRUG	Palbociclib	combination APG2575+pablociclib

Timeline

• Start date: 2021-08-13
• Primary completion: 2024-08-12
• Completion: 2024-10-01
• First posted: 2021-07-01
• Last updated: 2024-08-19

Locations

7 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study