Actively Recruiting
APG-2449 in Patients With Advanced Solid Tumors
Led by Ascentage Pharma Group Inc. · Updated on 2025-06-18
165
Participants Needed
9
Research Sites
448 weeks
Total Duration
On this page
Sponsors
A
Ascentage Pharma Group Inc.
Lead Sponsor
S
Suzhou Yasheng Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
APG-2449 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with advanced solid tumors including non-small cell lung cancer confirmed by histology or cytology and positive for ALK/ROS1 gene fusion, malignant pleural mesothelioma, esophageal cancer, or ovarian cancer
- Patients with non-small cell lung cancer who have progressed on or are intolerant to tyrosine kinase inhibitor (TKI) therapy or TKI-naive patients with ALK/ROS1 fusion gene positive NSCLC
- ECOG Performance Status of 0 or 1
- Expected life expectancy of at least 3 months
- At least one measurable tumor lesion according to RECIST version 1.1
- Adequate blood, bone marrow, kidney, liver, and normal heart function
- Brain metastases allowed if neurological symptoms are clinically controlled
- Negative pregnancy test within 7 days before starting study drug for women of childbearing potential
- Agreement to use contraception during the study and for at least 30 days after
- Ability to understand and sign informed consent
- Willingness and ability to complete study procedures and follow-up
- Provision of fresh or archived tumor tissue samples within 28 days prior to treatment
- Fresh biopsy tumor tissue specimen before treatment
You will not qualify if you...
- Receiving other anti-cancer therapies (chemotherapy, radiotherapy, immunotherapy, biologic therapy) or investigational drugs within 28 days before starting study drug
- Receiving tyrosine kinase inhibitor therapy within 8 days before starting study drug
- Persistent toxicities from prior therapy above Grade 1 (CTCAE V5.0)
- Difficulty swallowing or absorbing oral medications
- History of significant cardiovascular disease
- Not recovered adequately from recent major surgery within 28 days or minor surgery within 14 days before study entry
- Active infections including HIV or hepatitis B or C
- Known allergy to study drug ingredients
- Pregnant or breastfeeding women or those planning pregnancy during the study
- Any condition judged by investigators to threaten safety or interfere with study assessments
- Use of certain enzyme inhibitors or inducers (CYP3A4, CYP2C9, CYP2C19) within 1 week before starting study drug
- Use of CYP3A4 substrates with narrow therapeutic window within 1 week before starting study drug
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
2
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Not Yet Recruiting
3
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Not Yet Recruiting
4
Sun-Yat Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
5
The First affiliated hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
6
Henan Provincial Oncology Hospital
Zhengzhou, Henan, China
Actively Recruiting
7
Union Hospital medical college Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
8
Hunan Provincial Oncology Hospital
Changsha, Hunan, China
Actively Recruiting
9
Zhejiang Provincial Oncology Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
Y
Yifan Zhai, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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