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.
Beijing InnoCare Pharma Tech Co., Ltd.
266 participants
Dec 18, 2024
INTERVENTIONAL
Conditions
Summary
Evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ICP-248 in combination with azacitidine in patients with acute myelogenous leukemia and Myelodysplastic Syndromes.
Eligibility
Inclusion Criteria9
- 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 Criteria6
- 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.
Interventions
Eligible patients will receive ICP-248 orally as per the protocol，once daily for every 28 days as one treatment cycle
Eligible patients will receive azacitidine subcutaneously or intravenously as per the protocol，once daily on days 1-7 of each 28-day cycle.
Locations(15)
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NCT06656494