Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
165 participants
INTERVENTIONAL
2019-05-27
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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APG-2449
APG-2449 will be explored sequentially using a standard 3+3 escalation scheme at the dose escalation phase and up to 30-40 patient at the MTD/RP2D dose level.
APG-2449
Capsule, multiple dose cohorts, oral administration every day (QD) of a 28-day cycle
Interventions
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APG-2449
Capsule, multiple dose cohorts, oral administration every day (QD) of a 28-day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Expansion stage: cohort 1, patients with non-small cell lung cancer who have progressed or are intolerant to TKI therapy, including patients with second-generation ALK TKI, or either ROS1 TKI, or third-generation ALK inhibitor (lorlatinib, etc.) with pFAK expression (pFAK expression is subject to central laboratory results) of about 10 or above; Cohort 2, TKI-naïve patients with ALK/ROS1 fusion gene positive NSCLC. The molecular diagnosis results of the above patients can be confirmed by the investigator.
2. ECOG Performance Status ≤ 1.
3. Expectation of life ≥ 3 months.
4. According to RECIST version 1.1, there is at least 1 measurable lesion.
5. Adequate hematologic and bone marrow functions.
6. Adequate renal and liver function.
7. Normal cardiac function.
8. Brain metastases with clinically controlled neurologic symptoms.
9. Serum pregnancy test results of women of childbearing age were negative within 7 days before taking the first dose of study drug.
10. Men, women of childbearing age (postmenopausal women must have been menopausal for at least 12 months before they can be considered infertile) and their partners voluntarily take the study drug for at least 30 days after signing the informed consent form and taking the study drug as deemed effective by the investigator Contraceptive measures
11. Ability to understand and willingness to sign a written informed consent form
12. Subjects must be willing and able to complete the research procedures and follow-up inspections.
13. Subjects are required to provide fresh (for recurrent subjects only) or archived tumor tissue samples from within 28 days prior to treatment. If none of these specimens are available, they may be included after consultation with the sponsor.
14. Subjects should provide fresh biopsy tumor tissue specimens prior to treatment.
Exclusion Criteria
2. Receiving TKI therapy within 8 days prior to the first dose of study drug.
3. Continuance of toxicities due to prior therapy that do not recover (CTCAE V5.0 Grade\> 1).
4. Has difficulty in swallowing, absorbing barrier, or other diseases blocking APG-2449' taken.
5. Obvious cardiovascular disease history.
6. Failure to recover adequately, as judged by the investigator, from prior surgical procedures. Patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry.
7. Active symptomatic fungal, bacterial and/or viral infection including, but not limited to, active human immunodeficiency virus (HIV) or viral hepatitis (B or C).
8. Known allergies to study drug ingredients or their analogs.
9. Female subjects who are pregnant or breastfeeding, or expecting to become pregnant during the study period.
10. According to the judgment of the investigator or sponsor, any symptoms or disease of the subject may endanger its safety or interfere with the safety assessment of the study drug.
11. Subjects who have used CYP3A4, CYP2C9, or CYP2C19 moderately potent inhibitors or moderately potent inducers 1 week before receiving the study drug for the first time.
12. Subjects who used CYP3A4 substrates and narrow treatment window 1 week before the first study drug.
18 Years
ALL
No
Sponsors
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Suzhou Yasheng Pharmaceutical Co., Ltd.
INDUSTRY
Ascentage Pharma Group Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Li Zhang, Professor
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Xiaoyan Lin, Ph.D
Role: primary
Wu Zhuang, Ph.D
Role: primary
Yubiao Guo, Professor
Role: primary
Yanqiu Zhao, Professor
Role: primary
Gang Wu, Professor
Role: primary
Jianhua Chen, Professor
Role: primary
Yiping Zhang, Professor
Role: primary
References
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Ma Y, Song Z, Chen J, Zhao Y, Fang W, Guo Y, Dong Y, Yang Y, Wu G, Fang J, Lin X, Li J, Huang Y, Zhao Y, Hong S, Xue J, Zhang Y, Liu Q, Yang C, Xu L, Yang Y, Xiong D, Yang D, Zhai Y, Zhang L, Zhao H. Safety, pharmacokinetic, pharmacodynamic, and efficacy properties of orally administered APG-2449 in patients with advanced ALK + and ROS1 + non-small-cell lung cancer: a multicentre, open-label, single-arm phase 1 trial. EClinicalMedicine. 2025 Oct 16;89:103556. doi: 10.1016/j.eclinm.2025.103556. eCollection 2025 Nov.
Fang DD, Tao R, Wang G, Li Y, Zhang K, Xu C, Zhai G, Wang Q, Wang J, Tang C, Min P, Xiong D, Chen J, Wang S, Yang D, Zhai Y. Discovery of a novel ALK/ROS1/FAK inhibitor, APG-2449, in preclinical non-small cell lung cancer and ovarian cancer models. BMC Cancer. 2022 Jul 11;22(1):752. doi: 10.1186/s12885-022-09799-4.
Other Identifiers
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APG2449XC101
Identifier Type: -
Identifier Source: org_study_id
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