Menu
Recruiting NCT06656494

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

Phase I Interventional Acute Myelogenous Leukemia Myelodysplastic Syndromes (MDS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ICP-248, Azacitidine.
Who it may be relevant to
Registry conditions: Acute Myelogenous Leukemia, Myelodysplastic Syndromes (MDS). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • 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.

Primary outcome measures

  • Incidence, type, and severity of dose-limiting toxicity (DLT). [Time frame: 2.5 years]
  • Recommended phase II dose (RP2D) and/or maximum tolerated dose (MTD). [Time frame: 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]
  • AML cohort:Composite complete remission rate by Investigator per ELN 2017 criteria. [Time frame: 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]
  • 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]
Secondary outcome measures (12)
  • 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]
  • AML cohort：Composite complete remission rate by completion of cycle 2 by Investigator per ELN 2017 criteria. [Time frame: 2.5 years]
  • The incidence, nature, and severity of adverse events (AEs) as assessed per NCI-CTCAE v5.0 criteria. [Time frame: 2.5 years]
  • Maximum concentration (Cmax)of ICP-248. [Time frame: 2.5 years]
  • Area under the curve (AUC) of ICP-248. [Time frame: 2.5 years]
  • Time of maximum observed plasma(Tmax)of ICP-248. [Time frame: 2.5 years]
  • Trough concentration(Ctrough) of ICP-248. [Time frame: 2.5 years]
  • Apparent clearance (CL/F) of ICP-248. [Time frame: 2.5 years]
  • AML cohort：Partial Response (PR) by investigator per ELN 2017 criteria. [Time frame: 2.5 years]
  • AML cohort：Overall survival (OS) by investigator per ELN 2017 criteria. [Time frame: 2.5 years]
  • AML cohort：Duration of Response (DOR) by investigator per ELN 2017 criteria. [Time frame: 2.5 years]
  • AML cohort：Event-free Survival (EFS) by investigator per ELN 2017 criteria. [Time frame: 2.5 years]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 14 centers
  • Anhui Provincial Hospita — Hefei
  • Peking University People's Hospital — Beijing
  • The First Affiliated Hospital of Chongqing Medical University — Chongqing
  • Guangdong Provincial People's Hospital — Guangzhou
  • Nanfang Hospital Southern Medical University — Guangzhou
  • Henan Cancer Hospital — Zhengzhou
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan
  • The First Affiliated Hospital of Soochow University — Suzhou
  • … and 6 more centers
United States · 2 centers
  • Yale University, Yale Cancer Center — New Haven
  • NYU Langone Health — New York
Australia · 2 centers
  • St Vincent's Hospital — Sydney
  • Royal Perth Hospital — Perth

Identifiers

NCT: NCT06656494 · ICP-CL-01205

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗