Combining ICP-248 with Azacitidine for treating Acute Myelogenous Leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of ICP-248 in combination with azacitidine in patients with Acute Myelogenous Leukemia (AML). The study is divided into two parts: a dose escalation period followed by a dose expansion period. It aims to determine the optimal dosing and effectiveness of the treatment in both treatment-naïve and previously treated relapsed/refractory AML subjects.

Why it matters

Who can join: the full rules

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.

Where it's running

• Chao Family Comprehensive Cancer Center, University of California, Irvine
  Orange, California, United States Recruiting
• Yale University, Yale Cancer Center
  New Haven, Connecticut, United States Recruiting
• H Lee Moffitt Cancer Center & Research Institute
  Tampa, Florida, United States Recruiting
• NYU Langone Health
  New York, New York, United States Recruiting
• University of North Carolina at Chapel Hill
  Chapel Hill, North Carolina, United States Recruiting
• Medical College of Wisconsin
  Milwaukee, Wisconsin, United States Recruiting

Study contacts

• Study coordinator: Alexia Lu
• Email: CO_HGRAC@innocarepharma.com
• Phone: 010-66609745

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.