NCT06656494

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
266

participants targeted

Target at P75+ for phase_1

Timeline
20mo left

Started Dec 2024

Typical duration for phase_1

Geographic Reach
3 countries

18 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Dec 2024Jan 2028

First Submitted

Initial submission to the registry

October 21, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

December 18, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

April 13, 2026

Status Verified

February 1, 2026

Enrollment Period

2.5 years

First QC Date

October 21, 2024

Last Update Submit

April 8, 2026

Conditions

Myelodysplastic Syndromes (MDS)Acute Myelogenous Leukemia

Outcome Measures

Primary Outcomes (6)

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

    2.5 years

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

    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.

    2.5 years

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

    2.5 years

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

    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.

    2.5 years

Secondary Outcomes (20)

  • 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.

    2.5 years

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

    2.5 years

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

    2.5 years

  • Maximum concentration (Cmax)of ICP-248.

    2.5 years

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

    2.5 years

  • +15 more secondary outcomes

Study Arms (1)

ICP-248 in combination with azacitidine

EXPERIMENTAL
Drug: ICP-248Drug: Azacitidine

Interventions

ICP-248DRUG

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

ICP-248 in combination with azacitidine
AzacitidineDRUG

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

ICP-248 in combination with azacitidine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%.
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Yale University, Yale Cancer Center

New Haven, Connecticut, 06520, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

St Vincent's Hospital

Sydney, New South Wales, 2010, Australia

RECRUITING

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

RECRUITING

Anhui Provincial Hospita

Hefei, Anhui, 230001, China

RECRUITING

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510030, China

RECRUITING

Nanfang Hospital Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

Shengjing Hospital of China Medical University

Shengyang, Liaoning, 110004, China

RECRUITING

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

RECRUITING

Tianjin People's Hospital

Tianjin, Tianjin Municipality, 300192, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310012, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic Syndromes

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Central Study Contacts

Alexia Lu

CONTACT

010-66609745CO_HGRAC@innocarepharma.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2024

First Posted

October 24, 2024

Study Start

December 18, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

April 13, 2026

Record last verified: 2026-02

Locations

AU(2)CN(14)US(2)