Condition: Acute Myeloid Leukemia (AML) · Myelodysplastic Syndromes (MDS) · Sponsor: Ascentage Pharma Group Inc.
Acute myeloid leukemia is a malignant disorder characterized by the rapid, uncontrolled proliferation of malignant clonal hematopoietic stem cells that accumulate as immature, undifferentiated cells (blasts) in the bone marrow and circulation. APG-115 is a potent and orally active small-molecule MDM2 inhibitor, it binds to MDM2 protein and shows potent cell growth inhibitory activity in vitro with low nanomolar potencies in a subset of human cancer cell lines. APG-115 has demonstrated its strong antitumor activities with either daily or less frequent dosing-schedules in the acute leukemia xenograft models. This is a phase 1b, open-label, three-stages study that will initially evaluate the safety and PK/PD profile of APG-115 as a single agent, followed by a combination of APG-115 + azacytidine or cytarabine in R/R AML or MDS subjects. Patients will continue treatment for maximally 6 cycles or until progression of disease or unacceptable toxicity is observed or administrative discontinuation whichever occurs first. Patients who continue to be benefit after 6 cycles' treatment will receive additional cycles of treatment until progression of disease, unacceptable toxicity is observed or administrative discontinuation. (As long as it is proven safe).
This description comes directly from the study's public registry record.
Junyuan Qi, M.D. · +86-18622662361 · qi_jy@yahoo.com
Bo Jiang, M.D. · +86-22-23909067 · jianbo044@163.com
Always discuss trial participation with your own doctor first.
| The First Hospital of Peking University | Beijing, Beijing Municipality, China | Not Yet Recruiting |
| Guangzhou panyu central hospital | Guangzhou, Guangdong, China | Recruiting |
| Nanfang Hospital of Southern Medical University | Guangzhou, Guangdong, China | Recruiting |
| Henan Provincial Oncology Hospital | Zhengzhou, Henan, China | Recruiting |
| Union Hospital medical college Huazhong University of Science and Technology | Wuhan, Hubei, China | Recruiting |
| Zhongnan Hospital of Wuhan University | Wuhan, Hubei, China | Recruiting |
| Xiangya Hospital Central South University | Changsha, Hunan, China | Recruiting |
| The First Affilated Hospital of Ganzhou Medical University | Suzhou, Jiangsu, China | Not Yet Recruiting |
| The First affiliated hospital of Soochow University | Suzhou, Jiangsu, China | Recruiting |
| The First Affiliated Hospital of Nanchang University | Nanchang, Jiangxi, China | Not Yet Recruiting |
| First Hospital of Jilin University | Changchun, Jilin, China | Recruiting |
| Shanghai Jiao Tong University school of medicine Ruijing Hospital | Shanghai, Shanghai Municipality, China | Recruiting |
+ 2 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04275518