Actively Recruiting
A Phase Ib Study to Investigate Safety, Pharmacokinetics, and Pharmacodynamics of APG-115 Alone or Combined With Azacitidine or Cytarabine in Relapsed/Refractory AML and High-Risk MDS
Led by Ascentage Pharma Group Inc. · Updated on 2024-10-15
102
Participants Needed
14
Research Sites
N/A
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 (AML) is a cancer characterized by the rapid and uncontrolled growth of immature blood cells in the bone marrow and circulation. This trial evaluates APG-115, an oral small-molecule drug that inhibits MDM2 protein and has shown strong anti-cancer activity in lab and animal models. The study aims to assess the safety, pharmacokinetics, and pharmacodynamics of APG-115 alone and in combination with azacitidine or cytarabine in patients with relapsed or refractory AML and high-risk myelodysplastic syndromes (MDS). It is a phase 1b, open-label study sponsored by Ascentage Pharma Group Inc. The study is divided into three stages: Stage 1 involves dose escalation of APG-115 alone given orally once daily from days 1 to 7 in a 28-day cycle to determine the maximum tolerated dose and dose-limiting toxicities. Stage 2 tests combinations of APG-115 with azacitidine or cytarabine in a similar dose escalation design. Stage 3 is a dose expansion phase for the combination treatments. Treatment continues for up to six cycles or until disease progression, unacceptable side effects, or other reasons for stopping. Patients benefiting after six cycles may continue treatment if it remains safe. Participants will undergo regular assessments including monitoring for toxicities during the first treatment cycle, evaluation of treatment response at the end of cycle 1 and 2 and every two months up to six cycles, and survival follow-up for six months after treatment ends. Safety and drug effects will be closely tracked throughout. The main measure is the occurrence of dose-limiting toxicities during cycle 1. Secondary measures include overall response rate and overall survival. The study follows patients until disease progression or withdrawal, with ongoing safety monitoring.
CONDITIONS
Brief 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...
- Patients diagnosed with relapsed or refractory acute myeloid leukemia by WHO classification or relapsed/progressed high/very high risk myelodysplastic syndromes with IPSS-R score ≥4.5
- Age 18 years or older
- Adequate organ function
- Projected life expectancy of at least 12 weeks
- ECOG performance status of 0-1
- Ability to understand study requirements and provide signed informed consent
- White blood cell count less than 50 x 10⁹/L (hydroxyurea permitted to meet this criterion)
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia
- Leukemia biotherapy within 4 weeks prior to study drug or less than 5 half-lives of targeted small molecule therapy, or anticancer therapy within 28 days (whichever is longer)
- Uncontrolled illness such as active infection, severe heart failure (NYHA Class III or IV), unstable angina, significant arrhythmia, or psychiatric/social issues limiting study compliance
- Active infection requiring systemic antibiotics/antifungals, known active hepatitis B or C, or HIV infection
- Allogeneic or autologous hematopoietic stem cell transplantation within 12 months
- Active, uncontrolled central nervous system leukemia
- Prior treatment with systemic MDM2-p53 inhibitors
- Other conditions making participation unsuitable as judged by the investigator
- History of other malignancies within 2 years except adequately treated in situ carcinomas or skin cancers or surgically treated malignancies with curative intent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Multiple 28-day cycles until completion of up to 6 cycles or discontinuation
Participants receive APG-115 orally once daily from Days 1 to 7 every 28 days. After the first cycle of APG-115 alone, participants may receive a combination of APG-115 with Azacitidine or Cytarabine according to dose escalation schedules.
Visits during each 28-day cycle as per treatment administration schedule
Duration - Up to 6 months after the last treatment dose
Participants are monitored for overall survival and response after treatment ends.
Periodic visits for follow-up assessments
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.
B
Bo Jiang, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here