> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/trial/icp-248-in-combination-with-azacitidine-for-the-treatment-in-e270043d-49c9-4ac5-91f4-aacd5b51a756
> Record changed: 2026-10-13

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

NCT06656494

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

Phase

Phase 1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

Recruitment status

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

Participants

266

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

Lead sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

Start date

2024-12-18

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

Number of sites

22

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

## Title and summary

**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.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

**Short title**

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

**Official title**

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

## Status and phase

**Control arm**

Open label

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

**Recruitment status**

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

**Phase**

Phase 1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

## Dates

**Completion date**

2028-01-01

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

**First posted**

2024-10-24

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

**Registry last updated**

2026-08-18

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

**Primary completion date**

2027-06-01

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

**Start date**

2024-12-18

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

## Size and sites

**Participants**

266

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

**Participant count basis**

Estimated

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

**Planned participants**

266

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

**Protocol amendments**

4

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

**Number of sites**

22

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

## Sponsor and oversight

**Data monitoring committee**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

**Lead sponsor**

Beijing InnoCare Pharma Tech Co., Ltd.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

## Identifiers

**Registry ID**

NCT06656494

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

**ClinicalTrials.gov ID**

NCT06656494

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

## Study design

**Allocation**

Not applicable

**Model**

Single group

**Purpose**

Treatment

**Masking**

No masking

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

## Outcomes

### Primary outcomes

1. Incidence, type, and severity of dose-limiting toxicity (DLT).  
Timeframe: 2.5 years
2. Recommended phase II dose (RP2D) and/or maximum tolerated dose (MTD).  
Timeframe: 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.  
Timeframe: 2.5 years
4. AML cohort:Composite complete remission rate by Investigator per ELN 2017 criteria.  
Timeframe: 2.5 years
5. AML cohort：Composite complete remission rate by completion of cycle 2 by Investigator per ELN 2017 criteria.  
Timeframe: 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.  
Timeframe: 2.5 years

### Secondary outcomes

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.  
Timeframe: 2.5 years
2. AML cohort：Composite complete remission rate by completion of cycle 2 by Investigator per ELN 2017 criteria.  
Timeframe: 2.5 years
3. The incidence, nature, and severity of adverse events (AEs) as assessed per NCI-CTCAE v5.0 criteria.  
Timeframe: 2.5 years
4. Maximum concentration (Cmax)of ICP-248.  
Timeframe: 2.5 years
5. Area under the curve (AUC) of ICP-248.  
Timeframe: 2.5 years
6. Time of maximum observed plasma(Tmax)of ICP-248.  
Timeframe: 2.5 years
7. Trough concentration(Ctrough) of ICP-248.  
Timeframe: 2.5 years
8. Apparent clearance (CL/F) of ICP-248.  
Timeframe: 2.5 years
9. AML cohort：Partial Response (PR) by investigator per ELN 2017 criteria.  
Timeframe: 2.5 years
10. AML cohort：Overall survival (OS) by investigator per ELN 2017 criteria.  
Timeframe: 2.5 years
11. AML cohort：Duration of Response (DOR) by investigator per ELN 2017 criteria.  
Timeframe: 2.5 years
12. AML cohort：Event-free Survival (EFS) by investigator per ELN 2017 criteria.  
Timeframe: 2.5 years
13. AML cohort：Relapse-free Survival (RFS) by investigator per ELN 2017 criteria.  
Timeframe: 2.5 years
14. AML cohort：Morphologic leukemia-free state (MLFS) by investigator per ELN 2017 criteria.  
Timeframe: 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  
Timeframe: 2.5 years
16. MDS cohort：Complete remission(CR) rate by Investigator per revised IWG 2006 MDS Criteria  
Timeframe: 2.5 years
17. MDS cohort：Event-free survival (EFS) by Investigator per revised IWG 2006 MDS Criteria  
Timeframe: 2.5 years
18. MDS cohort：Duration of modified overall response (DmOR) by Investigator per revised IWG 2006 MDS Criteria  
Timeframe: 2.5 years
19. MDS cohort：Overall survival(OS) by Investigator per revised IWG 2006 MDS Criteria  
Timeframe: 2.5 years
20. MDS cohort：Marrow complete response (mCR) rate by Investigator per revised IWG 2006 MDS Criteria  
Timeframe: 2.5 years

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Healthy volunteers**

No

### 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.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

## Sites

- Chao Family Comprehensive Cancer Center, University of California, IrvineOrange, United StatesRecruiting
- Yale University, Yale Cancer CenterNew Haven, United StatesRecruiting
- H Lee Moffitt Cancer Center & Research InstituteTampa, United StatesRecruiting
- NYU Langone HealthNew York, United StatesRecruiting
- University of North Carolina at Chapel HillChapel Hill, United StatesRecruiting
- Medical College of WisconsinMilwaukee, United StatesRecruiting
- St Vincent's HospitalSydney, AustraliaRecruiting
- Royal Perth HospitalPerth, AustraliaRecruiting
- Anhui Provincial HospitaHefei, ChinaRecruiting
- Peking University People's HospitalBeijing, ChinaRecruiting
- The First Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaRecruiting
- Guangdong Provincial People's HospitalGuangzhou, ChinaRecruiting
- Nanfang Hospital Southern Medical UniversityGuangzhou, ChinaRecruiting
- Henan Cancer HospitalZhengzhou, ChinaRecruiting
- Union Hospital Tongji Medical College Huazhong University of Science and TechnologyWuhan, ChinaRecruiting
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaRecruiting
- The First Affiliated Hospital of Nanchang UniversityNanchang, ChinaRecruiting
- The First Hospital of Jilin UniversityChangchun, ChinaRecruiting
- Shengjing Hospital of China Medical UniversityShengyang, ChinaRecruiting
- Sichuan Provincial People's HospitalChengdu, ChinaRecruiting
- Tianjin People's HospitalTianjin, ChinaRecruiting
- The First Affiliated Hospital, Zhejiang University School of MedicineHangzhou, ChinaRecruiting

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06656494)

## Related records

### Drugs (1)

- [Azacitidine](https://trialight.com/data/asset/azacitidine-4f3798ea-680c-4288-a367-118b7bfe411f.md)

### Lead sponsors (1)

- [Beijing InnoCare Pharma Tech Co., Ltd.](https://trialight.com/data/company/beijing-innocare-pharma-tech-co-ltd-9eb561d6-b83b-45de-82bf-8993933a1f5f.md)

### Conditions (3)

- [Acute myeloid leukemia](https://trialight.com/data/condition/acute-myeloid-leukemia-b0971a7a-c18d-544e-bd7f-b1a13b9caa30.md) Primary condition
- [Leukemia](https://trialight.com/data/condition/leukemia-519aefcd-8521-5941-851b-5b77ca925ca5.md)
- [Myelodysplastic syndrome](https://trialight.com/data/condition/myelodysplastic-syndrome-f5df8ce5-6064-53d3-902c-f09fc4acd4bb.md)

### Targets (2)

- [DNMT1](https://trialight.com/data/target/dnmt1-993c1dd6-907e-5847-b9a6-2bc7fd678568.md)
- [DNMT3A](https://trialight.com/data/target/dnmt3a-8a6f7e66-0b4a-50cc-a497-9e9823091168.md)

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