Tests ICP-248 with azacitidine in leukemia and myelodysplastic syndromes
Tests ICP-248 with azacitidine in adults with leukemia or myelodysplastic syndromes.
Plain-language title generated from the registry record
Registry title: ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies
Key facts
- Where
- Beijing, Changchun, Chengdu, Chongqing, Guangzhou, Hangzhou, Hefei, Nanchang, Shengyang, Suzhou, Tianjin, Wuhan, and Zhengzhou, ChinaSee the 14 sites
- Phase
- Phase 1
Where in China
- Peking University People's HospitalBeijing, ChinaTaking people
- The First Hospital of Jilin UniversityChangchun, ChinaTaking people
- Sichuan Provincial People's HospitalChengdu, ChinaTaking people
- The First Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaTaking people
- Guangdong Provincial People's HospitalGuangzhou, ChinaTaking people
- Nanfang Hospital, Southern Medical UniversityGuangzhou, ChinaTaking people
- The First Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaTaking people
- Anhui Provincial HospitaHefei, ChinaTaking people
- The First Affiliated Hospital of NanChang UniversityNanchang, ChinaTaking people
- Shengjing Hospital of China Medical UniversityShengyang, ChinaTaking people
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaTaking people
- Tianjin People's HospitalTianjin, ChinaTaking people
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaTaking people
- Henan Cancer HospitalZhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beijing InnoCare Pharma Tech Co., Ltd.
- Trial code
- NCT06656494
- Record updated
- 18 August 2026
- Original description
Evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ICP-248 in combination with azacitidine in patients with acute myelogenous leukemia and Myelodysplastic Syndromes.Read full original descriptionShow less
A Phase 1 Study of ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies.
Evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ICP-248 in combination with azacitidine in patients with acute myelogenous leukemia and Myelodysplastic Syndromes.
Inclusion: 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; 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%; Subject must have a projected life expectancy of at least 12 weeks; 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.
Exclusion: 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; 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.