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of Medicine","Hangzhou","Zhejiang","310012",{"type":40,"coordinates":280},[281,282],120.16142,30.29365,{"lat":282,"lon":281},[285],{"name":286,"role":28,"phone":287,"phoneExt":11,"email":288},"Jie Jin","0571-87236898","jiej0503@163.com",{"type":290,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100566539",false,"NCT06656494","ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies","A Phase 1 Study of ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies.","Inclusion Criteria:\n\nEligible subjects must meet all of the following criteria:\n\n1. Subject must have confirmation of diagnosis of AML (except for acute promyelocytic leukemia \\[APL\\]) or MDS per 2016 World Health Organization (WHO) criteria.\n2. For AML (except for APL) cohort:\n\n   1. Previously treated relapsed\u002Frefractory AML subjects\n   2. Treatment-naïve AML subjects should be: ≥60 years of age OR ≥18 years and \\\u003C60 years will be eligible if the subject has at least one of the following co-morbidities, which make the subject unfit for intensive chemotherapy\n3. For MDS cohort: Adult TN MDS and R\u002FR MDS: revised International Prognostic Scoring System (IPSS-R) score \\> 3 and bone marrow blasts ≥ 5%.\n4. Subject must have a projected life expectancy of at least 12 weeks.\n5. Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL\u002Fmin; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft-Gault formula.\n6. Subject must have adequate liver function\n\nExclusion Criteria:\n\n1. R\u002FR AML or R\u002FR MDS with no response or intolerance to post azacitidine or BCL-2i.\n2. Subject has acute promyelocytic leukemia (French-American-British Class M3 AML) .\n3. Subject has known central nervous system (CNS) leukemia.\n4. Suggest patients with active hepatitis B or C virus infection\n5. History of immunodeficiency, including a positive human immunodeficiency virus (HIV) antibody test.\n6. Subjects have another active malignancy within the past 2 years before study entry, except for curatively treated.","ALL","18 Years",{"count":300,"type":301},266,"ESTIMATED","INTERVENTIONAL",[304],"PHASE1","Evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ICP-248 in combination with azacitidine in patients with acute myelogenous leukemia and Myelodysplastic Syndromes.",[307,308],"Acute Myelogenous Leukemia","Myelodysplastic Syndromes (MDS)","2026-04-08",{"date":311,"type":312},"2026-04-13","ACTUAL",{"date":314,"type":312},"2024-12-18",{"date":316,"type":301},"2028-01",{"name":5,"class":6},18]