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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 266 participants in total. It began in 2024-12-18 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06656494 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Myelogenous Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06656494 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06656494 currently recruiting?
Yes, NCT06656494 is actively recruiting participants. Contact the research team at CO_HGRAC@innocarepharma.com for enrollment information.
Where is the NCT06656494 trial being conducted?
This trial is being conducted at Orange, United States, New Haven, United States, Tampa, United States, New York, United States and 11 additional locations.
Who is sponsoring the NCT06656494 clinical trial?
NCT06656494 is sponsored by Beijing InnoCare Pharma Tech Co., Ltd.. The trial plans to enroll 266 participants.
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