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Taking people in ChinaPhase 1

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

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with acute myeloid leukemia (not acute promyelocytic leukemia) or myelodysplastic syndromes, either newly diagnosed or previously treated.

Age
18 years or older. Newly diagnosed AML: 60 years or older, or 18 to under 60 with a health problem that makes them unfit for intensive chemotherapy.
Sex
All sexes can join.
Disease stage
AML (not acute promyelocytic leukemia) or MDS per 2016 WHO criteria. AML can be newly diagnosed or relapsed/refractory. MDS can be newly diagnosed or relapsed/refractory, with an IPSS-R score above 3 and bone marrow blasts of 5% or more.
Earlier treatment
AML cohort: previously treated relapsed/refractory AML, or newly diagnosed AML who are unfit for intensive chemotherapy. People with relapsed/refractory AML or MDS who did not respond to, or could not tolerate, azacitidine or a BCL-2 inhibitor cannot join.

Main reasons for not taking part

  • Acute promyelocytic leukemia (FAB class M3 AML)
  • Known central nervous system (CNS) leukemia
  • Active hepatitis B or C infection
  • History of immunodeficiency, including a positive HIV antibody test
  • Another active cancer within the past 2 years before study entry, except curatively treated

Read by machine on 9 November 2026.

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

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.

ClinicalTrials.gov NCT06656494