Clinical trial · Interventional
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.
NCT06656494CI-TRIAL-00122518recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Myelodysplastic Syndromes (MDS) | Myelodysplastic Syndrome | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
| ICP-248 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ICP-248 in combination with azacitidine
- interventionNames
- Drug: ICP-248
- Drug: Azacitidine
Primary outcomes (6)
- measure
- Incidence, type, and severity of dose-limiting toxicity (DLT).
- timeFrame
- 2.5 years
- measure
- Recommended phase II dose (RP2D) and/or maximum tolerated dose (MTD).
- timeFrame
- 2.5 years
- measure
- 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.
- timeFrame
- 2.5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 liver function Exclusion Criteria: 1. R/R AML or R/R MDS with no response or intolerance to post azacitidine or BCL-2i. 2. Subject has acute promyelocytic leukemia (French-American-British Class M3 AML) . 3. Subject has known central nervous system (CNS) leukemia. 4. Suggest patients with active hepatitis B or C virus infection 5. History of immunodeficiency, including a positive human immunodeficiency virus (HIV) antibody test. 6. Subjects have another active malignancy within the past 2 years before study entry, except for curatively treated.
References
Publications (0)
Data not yet available
No reference posted for this study.