NCT06656494 ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies
| NCT ID | NCT06656494 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Beijing InnoCare Pharma Tech Co., Ltd. |
| Condition | Acute Myelogenous Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 266 participants |
| Start Date | 2024-12-18 |
| Primary Completion | 2027-06 |
Trial Parameters
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Brief 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 Criteria
Inclusion Criteria: Eligible subjects must meet all of the following 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
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