Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06656494

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

Led by Beijing InnoCare Pharma Tech Co., Ltd. · Updated on 2026-04-13

266

Participants Needed

18

Research Sites

158 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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

Not Eligible

You will not qualify if you...

  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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 18 locations

1

Yale University, Yale Cancer Center

New Haven, Connecticut, United States, 06520

Actively Recruiting

2

NYU Langone Health

New York, New York, United States, 10016

Actively Recruiting

3

St Vincent's Hospital

Sydney, New South Wales, Australia, 2010

Actively Recruiting

4

Royal Perth Hospital

Perth, Western Australia, Australia, 6000

Actively Recruiting

5

Anhui Provincial Hospita

Hefei, Anhui, China, 230001

Actively Recruiting

6

Peking University People's Hospital

Beijing, Beijing Municipality, China, 100044

Actively Recruiting

7

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China, 400042

Actively Recruiting

8

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China, 510030

Actively Recruiting

9

Nanfang Hospital Southern Medical University

Guangzhou, Guangdong, China, 510515

Actively Recruiting

10

Henan Cancer Hospital

Zhengzhou, Henan, China, 450000

Actively Recruiting

11

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China, 430000

Actively Recruiting

12

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215006

Actively Recruiting

13

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China, 330006

Actively Recruiting

14

The First Hospital of Jilin University

Changchun, Jilin, China, 130000

Actively Recruiting

15

Shengjing Hospital of China Medical University

Shengyang, Liaoning, China, 110004

Actively Recruiting

16

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China, 610072

Actively Recruiting

17

Tianjin People's Hospital

Tianjin, Tianjin Municipality, China, 300192

Actively Recruiting

18

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310012

Actively Recruiting

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Research Team

A

Alexia Lu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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