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

RecruitingPhase 1

Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Conditions: Acute Myelogenous Leukemia, Myelodysplastic Syndromes (MDS)

Interventions: ICP-248, Azacitidine

Countries: United States, Australia, China

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (22)

Orange, California, United States
New Haven, Connecticut, United States
Tampa, Florida, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Milwaukee, Wisconsin, United States
Sydney, New South Wales, Australia
Perth, Western Australia, Australia
Hefei, Anhui, China
Beijing, Beijing Municipality, China
Chongqing, Chongqing Municipality, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Zhengzhou, Henan, China
Wuhan, Hubei, China
Suzhou, Jiangsu, China
Nanchang, Jiangxi, China
Changchun, Jilin, China
Shengyang, Liaoning, China
Chengdu, Sichuan, China
Tianjin, Tianjin Municipality, China
Hangzhou, Zhejiang, China