ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies
NCT ID: NCT06656494
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
266 participants
INTERVENTIONAL
2024-12-18
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ICP-248 in combination with azacitidine
ICP-248
Eligible patients will receive ICP-248 orally as per the protocol，once daily for every 28 days as one treatment cycle
Azacitidine
Eligible patients will receive azacitidine subcutaneously or intravenously as per the protocol，once daily on days 1-7 of each 28-day cycle.
Interventions
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ICP-248
Eligible patients will receive ICP-248 orally as per the protocol，once daily for every 28 days as one treatment cycle
Azacitidine
Eligible patients will receive azacitidine subcutaneously or intravenously as per the protocol，once daily on days 1-7 of each 28-day cycle.
Eligibility Criteria
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Inclusion Criteria
1. Subject must have confirmation of diagnosis of AML (except for acute promyelocytic leukemia \[APL\]) or MDS per 2016 World Health Organization (WHO) criteria.
2. For AML (except for APL) cohort:
1. Previously treated relapsed/refractory AML subjects
2. 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
3. For MDS cohort: Adult TN MDS and R/R MDS: revised International Prognostic Scoring System (IPSS-R) score \> 3 and bone marrow blasts ≥ 5%.
4. Subject must have a projected life expectancy of at least 12 weeks.
5. 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.
6. Subject must have adequate liver function
Exclusion Criteria
2. Subject has acute promyelocytic leukemia (French-American-British Class M3 AML) .
3. Subject has known central nervous system (CNS) leukemia.
4. Suggest patients with active hepatitis B or C virus infection
5. History of immunodeficiency, including a positive human immunodeficiency virus (HIV) antibody test.
6. Subjects have another active malignancy within the past 2 years before study entry, except for curatively treated.
18 Years
ALL
No
Sponsors
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Beijing InnoCare Pharma Tech Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Anhui Provincial Hospita
Hefei, Anhui, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Shengjing Hospital of China Medical University
Shengyang, Liaoning, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ICP-CL-01205
Identifier Type: -
Identifier Source: org_study_id
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