ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies

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

  • Acute Myelogenous Leukemia
  • Myelodysplastic Syndromes (MDS)

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