Discovery of a novel ALK/ROS1/FAK inhibitor, APG-2449, in preclinical non-small cell lung cancer and ovarian cancer models.
Douglas D Fang, Ran Tao, Guangfeng Wang...
https://pubmed.ncbi.nlm.nih.gov/35820889/Actively Recruiting
Led by Ascentage Pharma Group Inc. · Updated on 2026-07-23
165
Participants Needed
9
Research Sites
4 weeks
Total Duration
Researchers are studying APG-2449, a new oral drug that targets multiple tyrosine kinases including FAK, ALK, and ROS1. This study focuses on adults with advanced solid tumors such as non-small cell lung cancer, esophageal cancer, ovarian cancer, and malignant pleural mesothelioma. The goal is to find the safest dose and understand the drugs effects in patients who have advanced cancers, including those resistant to other therapies. Participants will receive APG-2449 capsules daily in 28-day cycles. The study starts with a dose escalation phase using a standard 33 design to identify the maximum tolerated dose and recommended dose for future studies. About 30 to 40 patients will be treated at the determined safe dose level to further evaluate safety and preliminary effectiveness. During the trial, participants will undergo regular assessments including measuring drug levels in the blood, tumor response evaluations every 4 weeks, and monitoring of side effects. Researchers will also collect tumor tissue samples before treatment and monitor performance status and organ functions. The study may last until December 2027 with ongoing safety and efficacy evaluations throughout the treatment cycles.
CONDITIONS
APG-2449 in Patients With Advanced Solid Tumors
Y
Yifan Zhai, M.D., Ph.D.
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Ascentage Pharma Group Inc.
Lead Sponsor
Suzhou Yasheng Pharmaceutical Co., Ltd.
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Varies based on dose cohort
Participants receive APG-2449 capsules daily as part of a dose escalation phase to identify the maximum tolerated dose and recommended dose for further studies.
Standard 3+3 escalation scheme visits
Duration - Ongoing until study completion or discontinuation
Participants receive APG-2449 at the determined maximum tolerated or recommended dose to further evaluate safety and preliminary efficacy.
Regular visits during treatment cycles
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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Douglas D Fang, Ran Tao, Guangfeng Wang...
https://pubmed.ncbi.nlm.nih.gov/35820889/Yuxiang Ma, Zhengbo Song, Jianhua Chen...
https://pubmed.ncbi.nlm.nih.gov/41146927/Ascentage Pharma Group Inc.
Lead Sponsor
Suzhou Yasheng Pharmaceutical Co., Ltd.
Collaborating Sponsor