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RECRUITING
NCT03917043
PHASE1

APG-2449 in Patients With Advanced Solid Tumors

Sponsor: Ascentage Pharma Group Inc.

View on ClinicalTrials.gov

Summary

APG-2449 is a novel, orally active, multi-targeted tyrosine kinase inhibitor, which inhibits FAK, ALK, and ROS1 with nanomolar potencies. In preclinical studies, APG-2449 demonstrated potent antiproliferative activity in various cancer cell lines as a single agent. In combination treatment, APG-2449 enhanced anti-proliferative activities of several chemotherapeutic and targeted agents. It is indicated that APG-2449 may have a broad therapeutic potential for the treatment of human cancer as a single agent and in combination with other classes of anticancer drugs. APG-2449 is intended for the treatment of patients with advanced solid tumors. Upon completion of the Phase 1 dose escalation study to establish the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and/or recommended phase 2 dose (RP2D), several phase Ib/II studies will be implemented accordingly.

Official title: A Phase I Study of the Safety, Pharmacokinetic and Pharmacodynamic Properties of Orally Administered APG-2449 in Patients With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

165

Start Date

2019-05-27

Completion Date

2028-01

Last Updated

2025-06-18

Healthy Volunteers

No

Interventions

DRUG

APG-2449

Capsule, multiple dose cohorts, oral administration every day (QD) of a 28-day cycle

Locations (9)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Sun-Yat Sen University Cancer Center

Guangzhou, Guangdong, China

The First affiliated hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Henan Provincial Oncology Hospital

Zhengzhou, Henan, China

Union Hospital medical college Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Provincial Oncology Hospital

Changsha, Hunan, China

Zhejiang Provincial Oncology Hospital

Hangzhou, Zhejiang, China