APG-2449 in Patients With Advanced Solid Tumors

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.

NCT Number	NCT03917043
Lead Sponsor	Ascentage Pharma Group Inc. Collaborators: Suzhou Yasheng Pharmaceutical Co., Ltd.
Conditions	Advanced Solid Cancer, Non Small Cell Lung Cancer, Esophageal Cancer, Ovarian Cancer, Malignant Pleural Mesothelioma
Enrollment	165 participants
Start Date	2019-05-27
Primary Completion	2027-12 (estimated)
Study Completion	2028-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-23