Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ICP-248 in combination with azacitidine
  • 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: Azacitidine
    Eligible patients will receive azacitidine subcutaneously or intravenously as per the protocol,once daily on days 1-7 of each 28-day cycle.

Recruiting Locations

NYU Langone Health
New York 5128581, New York 5128638 10016
Contact:
Antoine Mesidor
212-263-4403
antoine.mesidor@nyulangone.org

More Details

Status
Recruiting
Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.

Study Contact

Alexia Lu
010-66609745
CO_HGRAC@innocarepharma.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.