RecruitingPhase 1NCT06656494

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

A Phase 1 Study of ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies.

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Enrollment

266 participants

Start Date

Dec 18, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Myelogenous Leukemia Myelodysplastic Syndromes (MDS)

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing ICP-248 combined with azacitidine (a chemotherapy drug) in patients with certain blood cancers: acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that have not responded to or have come back after previous treatments. **You may be eligible if...** - You have confirmed AML (not the APL subtype) or high-risk MDS - For AML: your cancer has relapsed or not responded to prior treatment, OR you are 60 or older with newly diagnosed AML, OR you are under 60 but have health conditions making intensive chemotherapy too risky - For MDS: your disease has a high IPSS-R risk score and at least 5% bone marrow blasts - You are expected to live at least 12 weeks **You may NOT be eligible if...** - You have the APL subtype of AML - You are under 18 - You have serious organ dysfunction or active serious infections - You have already received certain targeted treatments that conflict with this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGICP-248

Eligible patients will receive ICP-248 orally as per the protocol，once daily for every 28 days as one treatment cycle

DRUGAzacitidine

Eligible patients will receive azacitidine subcutaneously or intravenously as per the protocol，once daily on days 1-7 of each 28-day cycle.

Locations(18)

Yale University, Yale Cancer Center

New Haven, Connecticut, United States

NYU Langone Health

New York, New York, United States

St Vincent's Hospital

Sydney, New South Wales, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

Anhui Provincial Hospita

Hefei, Anhui, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Nanfang Hospital Southern Medical University

Guangzhou, Guangdong, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

Shengjing Hospital of China Medical University

Shengyang, Liaoning, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Tianjin People's Hospital

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06656494

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