Actively Recruiting
ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies
Led by Beijing InnoCare Pharma Tech Co., Ltd. · Updated on 2026-04-13
266
Participants Needed
18
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ICP-248 in combination with azacitidine in patients with acute myelogenous leukemia and Myelodysplastic Syndromes.
CONDITIONS
Official 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...
Eligible subjects must meet all of the following criteria:
-
Subject must have confirmation of diagnosis of AML (except for acute promyelocytic leukemia [APL]) or MDS per 2016 World Health Organization (WHO) criteria.
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For AML (except for APL) cohort:
- Previously treated relapsed/refractory AML subjects
- Treatment-naïve AML subjects should be: ≥60 years of age OR ≥18 years and <60 years will be eligible if the subject has at least one of the following co-morbidities, which make the subject unfit for intensive chemotherapy
-
For MDS cohort: Adult TN MDS and R/R MDS: revised International Prognostic Scoring System (IPSS-R) score > 3 and bone marrow blasts ≥ 5%.
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Subject must have a projected life expectancy of at least 12 weeks.
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Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft-Gault formula.
-
Subject must have adequate liver function
You will not qualify if you...
- R/R AML or R/R MDS with no response or intolerance to post azacitidine or BCL-2i.
- Subject has acute promyelocytic leukemia (French-American-British Class M3 AML) .
- Subject has known central nervous system (CNS) leukemia.
- Suggest patients with active hepatitis B or C virus infection
- History of immunodeficiency, including a positive human immunodeficiency virus (HIV) antibody test.
- Subjects have another active malignancy within the past 2 years before study entry, except for curatively treated.
AI-Screening
AI-Powered Screening
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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
Actively Recruiting
5
Anhui Provincial Hospita
Hefei, Anhui, China, 230001
Actively Recruiting
6
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
7
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400042
Actively Recruiting
8
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510030
Actively Recruiting
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
Actively Recruiting
12
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
13
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
14
The First Hospital of Jilin University
Changchun, Jilin, China, 130000
Actively Recruiting
15
Shengjing Hospital of China Medical University
Shengyang, Liaoning, China, 110004
Actively Recruiting
16
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Actively Recruiting
17
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China, 300192
Actively Recruiting
18
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310012
Actively Recruiting
Research Team
A
Alexia Lu
CONTACT
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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