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

August 17, 2026 updated by: Beijing InnoCare Pharma Tech Co., Ltd.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
266

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2010
        • Recruiting
        • St Vincent's Hospital
        • Contact:
    • Western Australia
      • Perth, Western Australia, Australia, 6000
  • China
    • Anhui
      • Hefei, Anhui, China, 230001
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400042
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital Southern Medical University
        • Contact:
      • Guangzhou, Guangdong, China, 510030
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
        • Contact:
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital Of Nanchang University
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130000
        • Recruiting
        • The First hospital of Jilin University
        • Contact:
    • Liaoning
      • Shengyang, Liaoning, China, 110004
        • Recruiting
        • Shengjing Hospital of China Medical University
        • Contact:
    • Sichuan
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300192
        • Recruiting
        • Tianjin People's Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310012
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
  • United States
    • California
      • Orange, California, United States, 92868-3201
        • Recruiting
        • Chao Family Comprehensive Cancer Center, University of California, Irvine
        • Contact:
          • Chao Family Comprehensive Cancer Center University of California, Irvine
          • Phone Number: 1-877-827-8839
          • Email: ucstudy@uci.edu
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University, Yale Cancer Center
        • Contact:
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • H Lee Moffitt Cancer Center & Research Institute
        • Contact:
    • New York
      • New York, New York, United States, 10016
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7305
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
          • Medical College of Wisconsin Clinical Trials Office
          • Phone Number: 8900 866-680-0505
          • Email: cccto@mcw.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence, type, and severity of dose-limiting toxicity (DLT).
Time Frame: 2.5 years
2.5 years
Recommended phase II dose (RP2D) and/or maximum tolerated dose (MTD).
Time Frame: 2.5 years
2.5 years
The incidence, nature, and severity of adverse events (AEs) as assessed per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0) criteria.
Time Frame: 2.5 years
2.5 years
AML cohort:Composite complete remission rate by Investigator per ELN 2017 criteria.
Time Frame: 2.5 years
2.5 years
AML cohort：Composite complete remission rate by completion of cycle 2 by Investigator per ELN 2017 criteria.
Time Frame: 2.5 years
2.5 years
MDS cohort：mOR rate, including CR, mCR, and PR, assessed by Investigator at any time point during the study per revised IWG 2006 MDS Criteria.
Time Frame: 2.5 years
2.5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The incidence, nature, and severity of adverse events (AEs) as assessed per NCI-CTCAE v5.0 criteria.
Time Frame: 2.5 years
2.5 years
Maximum concentration (Cmax)of ICP-248.
Time Frame: 2.5 years
2.5 years
Area under the curve (AUC) of ICP-248.
Time Frame: 2.5 years
2.5 years
Time of maximum observed plasma(Tmax)of ICP-248.
Time Frame: 2.5 years
2.5 years
Trough concentration(Ctrough) of ICP-248.
Time Frame: 2.5 years
2.5 years
Apparent clearance (CL/F) of ICP-248.
Time Frame: 2.5 years
2.5 years
AML cohort：Composite complete remission rate by completion of cycle 2 by Investigator per ELN 2017 criteria.
Time Frame: 2.5 years
2.5 years
AML cohort：Composite complete remission rate: The proportion of subjects with complete remission (CR) and CR with incomplete hematologic recovery (CRi) by Investigator per European Leukemia Net (ELN) 2017 criteria.
Time Frame: 2.5 years
2.5 years
AML cohort：Partial Response (PR) by investigator per ELN 2017 criteria.
Time Frame: 2.5 years
2.5 years
AML cohort：Overall survival (OS) by investigator per ELN 2017 criteria.
Time Frame: 2.5 years
2.5 years
AML cohort：Duration of Response (DOR) by investigator per ELN 2017 criteria.
Time Frame: 2.5 years
2.5 years
AML cohort：Event-free Survival (EFS) by investigator per ELN 2017 criteria.
Time Frame: 2.5 years
2.5 years
AML cohort：Relapse-free Survival (RFS) by investigator per ELN 2017 criteria.
Time Frame: 2.5 years
2.5 years
AML cohort：Morphologic leukemia-free state (MLFS) by investigator per ELN 2017 criteria.
Time Frame: 2.5 years
2.5 years
MDS cohort：Modified overall response (mOR) rate, including CR, marrow complete response (mCR), and PR, assessed by Investigator at any time point during the study per revised International Working Group (IWG) 2006 MDS Criteria
Time Frame: 2.5 years
2.5 years
MDS cohort：Complete remission(CR) rate by Investigator per revised IWG 2006 MDS Criteria
Time Frame: 2.5 years
2.5 years
MDS cohort：Event-free survival (EFS) by Investigator per revised IWG 2006 MDS Criteria
Time Frame: 2.5 years
2.5 years
MDS cohort：Duration of modified overall response (DmOR) by Investigator per revised IWG 2006 MDS Criteria
Time Frame: 2.5 years
2.5 years
MDS cohort：Overall survival(OS) by Investigator per revised IWG 2006 MDS Criteria
Time Frame: 2.5 years
2.5 years
MDS cohort：Marrow complete response (mCR) rate by Investigator per revised IWG 2006 MDS Criteria
Time Frame: 2.5 years
2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing InnoCare Pharma Tech Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ICP-CL-01205

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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