ICP-248 with Azacitidine for Myeloid Malignancies
This study is testing a new combination treatment for people with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS), which are types of blood cancers. It combines ICP-248, taken by mouth once a day, with azacitidine, given as an injection or IV once a day for seven days each cycle. The main goals are to see how safe this combination is, what side effects might occur, and to find the best dose. You may be eligible if you are 18 or older and have been diagnosed with AML (excluding a specific type called APL) or MDS, especially if your AML has returned or not responded to previous treatments. The study plans to enroll up to 266 participants.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It aims to enroll up to 266 participants, but the specific phase of the study is not provided.
- What's involved
- You would receive ICP-248 orally once daily for 28 days per cycle, and azacitidine subcutaneously or intravenously once daily on days 1-7 of each 28-day cycle.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will monitor side effects and determine the best dose for up to 2.5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies
At a glance
Conditions
Where it's being run
22 sites across 21 statesWho to contact
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What this trial measures
- Incidence, type, and severity of dose-limiting toxicity (DLT).2.5 years
- Recommended phase II dose (RP2D) and/or maximum tolerated dose (MTD).2.5 years
- The incidence, nature, and severity of adverse events (AEs) as assessed per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0) criteria.2.5 years
- AML cohort:Composite complete remission rate by Investigator per ELN 2017 criteria.2.5 years
- AML cohort：Composite complete remission rate by completion of cycle 2 by Investigator per ELN 2017 criteria.2.5 years
- MDS cohort：mOR rate, including CR, mCR, and PR, assessed by Investigator at any time point during the study per revised IWG 2006 MDS Criteria.2.5 years