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

Recruiting now · Phase 1

Conditions studied: Acute Myelogenous Leukemia, Myelodysplastic Syndromes (MDS)

In brief

Evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ICP-248 in combination with azacitidine in patients with acute myelogenous leukemia and Myelodysplastic Syndromes.

Key facts

Study ID

NCT06656494

Run by

Beijing InnoCare Pharma Tech Co., Ltd.

People needed

266

Starts

2024-12-18

Expected to finish

2028-01-01

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eligible subjects must meet all of the following criteria:
• Subject must have confirmation of diagnosis of AML (except for acute promyelocytic leukemia [APL]) or MDS per 2016 World Health Organization (WHO) criteria.
• For AML (except for APL) cohort:
• Previously treated relapsed/refractory AML subjects
• 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
• For MDS cohort: Adult TN MDS and R/R MDS: revised International Prognostic Scoring System (IPSS-R) score > 3 and bone marrow blasts ≥ 5%.
• Subject must have a projected life expectancy of at least 12 weeks.
• 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.
• Subject must have adequate liver function

You may not qualify if…

• R/R AML or R/R MDS with no response or intolerance to post azacitidine or BCL-2i.
• Subject has acute promyelocytic leukemia (French-American-British Class M3 AML) .
• Subject has known central nervous system (CNS) leukemia.
• Suggest patients with active hepatitis B or C virus infection
• History of immunodeficiency, including a positive human immunodeficiency virus (HIV) antibody test.
• Subjects have another active malignancy within the past 2 years before study entry, except for curatively treated.

Where it is running

• Yale University, Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• St Vincent's Hospital — Sydney, New South Wales, Australia (enrolling)
• Royal Perth Hospital — Perth, Western Australia, Australia (enrolling)
• Anhui Provincial Hospita — Hefei, Anhui, China (enrolling)
• Peking University People's Hospital — Beijing, Beijing Municipality, China (enrolling)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (enrolling)
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (enrolling)
• Nanfang Hospital Southern Medical University — Guangzhou, Guangdong, China (enrolling)
• Henan Cancer Hospital — Zhengzhou, Henan, China (enrolling)
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (enrolling)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (enrolling)
• The First Hospital of Jilin University — Changchun, Jilin, China (enrolling)
• Shengjing Hospital of China Medical University — Shengyang, Liaoning, China (enrolling)
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (enrolling)
• Tianjin People's Hospital — Tianjin, Tianjin Municipality, China (enrolling)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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