Actively Recruiting
A Phase Ib Study of APG-115 Single Agent or in Combination With Azacitidine or Cytarabine in Patients With AML and MDS.
Led by Ascentage Pharma Group Inc. · Updated on 2024-10-15
102
Participants Needed
14
Research Sites
286 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
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).
CONDITIONS
Official Title
A Phase Ib Study of APG-115 Single Agent or in Combination With Azacitidine or Cytarabine in Patients With AML and MDS.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with relapsed or refractory acute myeloid leukemia (AML) or relapsed/progressed high/very high risk myelodysplastic syndromes (MDS) with IPSS-R score 6.5
- Age 18 years or older
- Adequate organ function
- Projected life expectancy of at least 12 weeks
- ECOG performance status of 0 or 1
- Able to understand study requirements and provide signed informed consent
- White blood cell count less than 50 �d7 10^9/L (hydroxyurea allowed to meet this requirement)
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia
- Received leukemia biotherapy within 4 weeks, small molecular targeted drug therapy within 5 half-lives, or any anti-cancer therapy within 28 days before starting study drug
- Uncontrolled illnesses such as active infections, severe heart failure (NYHA Class III or IV), unstable angina, significant heart arrhythmia, or psychiatric/social conditions limiting study compliance
- Active infection requiring systemic antibiotics or antifungals, known active hepatitis B or C, or HIV infection
- Received allogeneic or autologous hematopoietic stem cell transplant within 12 months
- Active, uncontrolled central nervous system leukemia
- Prior treatment with systemic MDM2-p53 inhibitors
- Other conditions making participation unsuitable per investigator judgment
- History of other cancers within 2 years except adequately treated in situ cervical or breast carcinoma, basal or localized squamous cell skin carcinoma, or resected malignancies treated with curative intent (discussion with sponsor required)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
The First Hospital of Peking University
Beijing, Beijing Municipality, China, 100034
Not Yet Recruiting
2
Guangzhou panyu central hospital
Guangzhou, Guangdong, China
Actively Recruiting
3
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Actively Recruiting
4
Henan Provincial Oncology Hospital
Zhengzhou, Henan, China
Actively Recruiting
5
Union Hospital medical college Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
6
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Actively Recruiting
7
Xiangya Hospital Central South University
Changsha, Hunan, China
Actively Recruiting
8
The First Affilated Hospital of Ganzhou Medical University
Suzhou, Jiangsu, China, 215636
Not Yet Recruiting
9
The First affiliated hospital of Soochow University
Suzhou, Jiangsu, China
Actively Recruiting
10
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
11
First Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
12
Shanghai Jiao Tong University school of medicine Ruijing Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
13
Shanghai Sixth people's Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
14
Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
J
Junyuan Qi, M.D.
CONTACT
B
Bo Jiang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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