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APG-2449 in Patients With Advanced Solid Tumors
Sponsor: Ascentage Pharma Group Inc.
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
Conditions
Interventions
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