OncoMatch/Clinical Trials/NCT03917043
APG-2449 in Patients With Advanced Solid Tumors
Is NCT03917043 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies APG-2449 for advanced solid cancer.
Treatment: APG-2449 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Esophageal Carcinoma
Ovarian Cancer
Mesothelioma
Biomarker criteria
Required: ALK fusion
positive for ALK/ROS1 gene fusion (molecular diagnosis confirmed by the investigator)
Required: ROS1 fusion
positive for ALK/ROS1 gene fusion (molecular diagnosis confirmed by the investigator)
Required: PTK2 pFAK expression of about 10 or above (about 10 or above)
pFAK expression (pFAK expression is subject to central laboratory results) of about 10 or above
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: ALK inhibitor (second-generation ALK TKI, third-generation ALK inhibitor (lorlatinib, etc.))
patients with non-small cell lung cancer who have progressed or are intolerant to TKI therapy, including patients with second-generation ALK TKI, or ... third-generation ALK inhibitor (lorlatinib, etc.)
Must have received: ROS1 inhibitor (ROS1 TKI)
patients with non-small cell lung cancer who have progressed or are intolerant to TKI therapy, including patients with ... either ROS1 TKI
Cannot have received: TKI therapy
Exception: within 8 days prior to the first dose of study drug
Receiving TKI therapy within 8 days prior to the first dose of study drug
Cannot have received: anti-cancer therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy)
Exception: within 28 days prior to the first dose of study drug
Receiving concurrent anti-cancer therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy); or any investigational therapy within 28 days prior to the first dose of study drug
Cannot have received: investigational therapy
Exception: within 28 days prior to the first dose of study drug
any investigational therapy within 28 days prior to the first dose of study drug
Lab requirements
Blood counts
adequate hematologic and bone marrow functions
Kidney function
adequate renal function
Liver function
adequate liver function
Cardiac function
normal cardiac function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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