ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies
NCT06656494 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 266
Last updated 2026-04-13
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.
Conditions
- Acute Myelogenous Leukemia
- Myelodysplastic Syndromes (MDS)
Interventions
- DRUG
-
ICP-248
Eligible patients will receive ICP-248 orally as per the protocol,once daily for every 28 days as one treatment cycle
- DRUG
-
Eligible patients will receive azacitidine subcutaneously or intravenously as per the protocol,once daily on days 1-7 of each 28-day cycle.
Sponsors & Collaborators
-
Beijing InnoCare Pharma Tech Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-18
- Primary Completion
- 2027-06-30
- Completion
- 2028-01-31
- FDA Drug
- Yes
Countries
- United States
- Australia
- China
Study Locations
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