Actively Recruiting
A Phase 1 Study of ICP-248 Combined With Azacitidine for Treating Patients With Myeloid Malignancies
Led by Beijing InnoCare Pharma Tech Co., Ltd. · Updated on 2026-04-13
266
Participants Needed
18
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, how the body processes, and early effects of ICP-248 combined with azacitidine in patients with acute myelogenous leukemia (AML) and myelodysplastic syndromes (MDS). The study focuses on these blood cancers to better understand potential treatment options. This is a phase 1 clinical trial sponsored by Beijing InnoCare Pharma Tech Co., Ltd. aimed at determining appropriate dosing and monitoring adverse effects. Participants will receive ICP-248 orally once daily in 28-day treatment cycles. Alongside, azacitidine will be given either by injection under the skin or into a vein once daily on days 1 through 7 of each cycle. The study will track responses in two groups: those with AML and those with MDS, observing remission rates and other clinical responses over about 2.5 years. During the study, participants will undergo regular assessments for side effects using standard criteria, blood tests to measure drug levels, and evaluations of disease response. The main outcomes include the rate and severity of treatment-related toxicities, remission rates, and survival measures. This careful monitoring will last for approximately 2.5 years to gather detailed information about the treatment’s impact and safety.
CONDITIONS
Brief Title
ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis confirmed as AML (excluding acute promyelocytic leukemia) or MDS according to 2016 WHO criteria
- For AML patients: relapsed/refractory or treatment-nafve and age 60 years or older, or 18-59 years with co-morbidities making them unfit for intensive chemotherapy
- For MDS patients: treatment-nafve or relapsed/refractory with IPSS-R score greater than 3 and bone marrow blasts 5% or higher
- Projected life expectancy of at least 12 weeks
- Adequate kidney function with creatinine clearance of at least 30 mL/min
- Adequate liver function
You will not qualify if you...
- Relapsed/refractory AML or MDS patients with no response or intolerance to previous azacitidine or BCL-2 inhibitor treatments
- Diagnosis of acute promyelocytic leukemia (French-American-British Class M3 AML)
- Known central nervous system leukemia
- Active hepatitis B or C virus infection
- History of immunodeficiency including positive HIV antibody test
- Another active cancer within the past 2 years except those curatively treated
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 - Repeated 28-day cycles until disease progression or discontinuation
Participants receive ICP-248 orally once daily and azacitidine subcutaneously or intravenously once daily on days 1-7 of each 28-day cycle as treatment for myeloid malignancies.
At least 1 visit per cycle for assessments and treatment administration
Duration - Up to 2.5 years
Participants are monitored for safety and treatment outcomes for up to 2.5 years after treatment ends.
Periodic visits as scheduled by the study team
Trial Site Locations
Total: 18 locations
1
Yale University, Yale Cancer Center
New Haven, Connecticut, United States, 06520
Actively Recruiting
2
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
3
St Vincent's Hospital
Sydney, New South Wales, Australia, 2010
Actively Recruiting
4
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
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5
Anhui Provincial Hospita
Hefei, Anhui, China, 230001
Actively Recruiting
6
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
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7
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400042
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8
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510030
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9
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
10
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
11
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
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12
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
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13
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
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14
The First Hospital of Jilin University
Changchun, Jilin, China, 130000
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15
Shengjing Hospital of China Medical University
Shengyang, Liaoning, China, 110004
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16
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
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17
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China, 300192
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18
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310012
Actively Recruiting
Research Team
A
Alexia Lu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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