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Acute Myelogenous LeukemiaPhase 1NCT06656494

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

A Phase 1 study testing ICP-248 and Azacitidine in people with Acute Myelogenous Leukemia and Myelodysplastic Syndromes (MDS), run by Beijing InnoCare Pharma Tech Co., Ltd. at 22 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ICP-248 and Azacitidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
266 participants
Where
22 sitesin 3 countries
Study dates
18 Dec 2024to Jan 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%.
Show all 9Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

22 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Alexia Lu contact

010-66609745

CO_HGRAC@innocarepharma.com

22 sites in 3 countries

China14 sites, 14 recruiting

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

    Qian Jiang, 010-88326850, jiangqian@medmail.com.cn

    Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin, 130000

    Sujun Gao, sujung1963@163.com

    Recruiting

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

    xiaobing Huang, huangxiaobing@med.uestc.edu.cn

    Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400042

    Li Wang, liwangls@yahoo.com

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510030

    Jianyu Weng, wengjianyu1969@163.com

    Recruiting

  • Nanfang Hospital Southern Medical University

    Guangzhou, Guangdong, 510515

    Yunyun Pan, huiyun1227@163.com

    Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310012

    Jie Jin, 0571-87236898, jiej0503@163.com

    Recruiting

  • Anhui Provincial Hospita

    Hefei, Anhui, 230001

    Xiaoyu Zhu, xiaoyuz@ustc.edu.cn

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Fei Li, 0791-88692743, lifeigcp2022@163.com

    Recruiting

  • Shengjing Hospital of China Medical University

    Shengyang, Liaoning, 110004

    Aijun Liao, liaoaijun@sina.com

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

    Suning Chen, 0512-67781137, chensuning@suda.edu.cn

    Recruiting

  • Tianjin People's Hospital

    Tianjin, Tianjin Municipality, 300192

    Xingli Zhao, 022-27557959, insectzhao@163.com

    Recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

    Zhichao Chen, chenzhichao@hust.edu.cn

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

    Xudong Wei, 0371-65587038, weixudong63@126.com

    Recruiting

Other trials in China

United States6 sites, 6 recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-7305

    Study Coordinator, +1 919-966-4432, cancerclinicaltrials@med.unc.edu

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Medical College of Wisconsin Clinical Trials Office, 866-680-0505 ext. 8900, cccto@mcw.edu

    Recruiting

  • Yale University, Yale Cancer Center

    New Haven, Connecticut, 06520

    Farah Fasihuddin, (203) 494-4610, farah.fasihuddin@yale.edu

    Recruiting

  • NYU Langone Health

    New York, New York, 10016

    Antoine Mesidor, 212-263-4403, antoine.mesidor@nyulangone.org

    Recruiting

  • Chao Family Comprehensive Cancer Center, University of California, Irvine

    Orange, California, 92868-3201

    Chao Family Comprehensive Cancer Center University of California, Irvine, 1-877-827-8839, ucstudy@uci.edu

    Recruiting

  • H Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

    Fernando Bustamante, 813-745-5358, fernando.bustamante@moffitt.org

    Recruiting

Other trials in United States

Australia2 sites, 2 recruiting

  • Royal Perth Hospital

    Perth, Western Australia, 6000

    Hun Chuah, 0892242405, HunSheng.Chuah@health.wa.gov.au

    Recruiting

  • St Vincent's Hospital

    Sydney, New South Wales, 2010

    Keith Fay, 0478267680, keith.fay@svha.org.au

    Recruiting

Other trials in Australia

About this study

Official title: 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.

Being tested
ICP-248, Azacitidine
Medical subject headings
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ICP-248Drug

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

  • AzacitidineDrug

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

Study groups in NCT06656494
Study groupRoleWhat they receive
ICP-248 in combination with azacitidineExperimentalNot described
Receives: Drug: ICP-248; Drug: Azacitidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence, type, and severity of dose-limiting toxicity (DLT).

    Measured: 2.5 years

  2. Recommended phase II dose (RP2D) and/or maximum tolerated dose (MTD).

    Measured: 2.5 years

  3. 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.

    Measured: 2.5 years

  4. AML cohort:Composite complete remission rate by Investigator per ELN 2017 criteria.

    Measured: 2.5 years

  5. AML cohort：Composite complete remission rate by completion of cycle 2 by Investigator per ELN 2017 criteria.

    Measured: 2.5 years

  6. 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.

    Measured: 2.5 years

Secondary outcomes (20)

  1. 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.

    Measured: 2.5 years

  2. AML cohort：Composite complete remission rate by completion of cycle 2 by Investigator per ELN 2017 criteria.

    Measured: 2.5 years

  3. The incidence, nature, and severity of adverse events (AEs) as assessed per NCI-CTCAE v5.0 criteria.

    Measured: 2.5 years

  4. Maximum concentration (Cmax)of ICP-248.

    Measured: 2.5 years

  5. Area under the curve (AUC) of ICP-248.

    Measured: 2.5 years

  6. Time of maximum observed plasma(Tmax)of ICP-248.

    Measured: 2.5 years

  7. Trough concentration(Ctrough) of ICP-248.

    Measured: 2.5 years

  8. Apparent clearance (CL/F) of ICP-248.

    Measured: 2.5 years

  9. AML cohort：Partial Response (PR) by investigator per ELN 2017 criteria.

    Measured: 2.5 years

  10. AML cohort：Overall survival (OS) by investigator per ELN 2017 criteria.

    Measured: 2.5 years

  11. AML cohort：Duration of Response (DOR) by investigator per ELN 2017 criteria.

    Measured: 2.5 years

  12. AML cohort：Event-free Survival (EFS) by investigator per ELN 2017 criteria.

    Measured: 2.5 years

  13. AML cohort：Relapse-free Survival (RFS) by investigator per ELN 2017 criteria.

    Measured: 2.5 years

  14. AML cohort：Morphologic leukemia-free state (MLFS) by investigator per ELN 2017 criteria.

    Measured: 2.5 years

  15. 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

    Measured: 2.5 years

  16. MDS cohort：Complete remission(CR) rate by Investigator per revised IWG 2006 MDS Criteria

    Measured: 2.5 years

  17. MDS cohort：Event-free survival (EFS) by Investigator per revised IWG 2006 MDS Criteria

    Measured: 2.5 years

  18. MDS cohort：Duration of modified overall response (DmOR) by Investigator per revised IWG 2006 MDS Criteria

    Measured: 2.5 years

  19. MDS cohort：Overall survival(OS) by Investigator per revised IWG 2006 MDS Criteria

    Measured: 2.5 years

  20. MDS cohort：Marrow complete response (mCR) rate by Investigator per revised IWG 2006 MDS Criteria

    Measured: 2.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2024
  2. Study start18 Dec 2024
  3. Primary completionJun 2027 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
266 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06656494
Sponsor's protocol ID
ICP-CL-01205
Status last verified
Feb 2026
First submitted
21 Oct 2024
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ICP-248 and Azacitidine in people with Acute Myelogenous Leukemia and Myelodysplastic Syndromes (MDS), run by Beijing InnoCare Pharma Tech Co., Ltd. at 22 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in China, United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alexia Lu (010-66609745, CO_HGRAC@innocarepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence, type, and severity of dose-limiting toxicity (DLT). (time frame: 2.5 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06656494.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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