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

InnoCare Pharma

Status and phase: Enrolling; Phase 1

Conditions: Acute Myelogenous Leukemia; Myelodysplastic Syndromes (MDS)

Treatments: Drug: Azacitidine; Drug: ICP-248

Study type: Interventional

Funder types: Industry

Identifiers

NCT06656494

ICP-CL-01205

Details and patient eligibility

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.

Enrollment: 266 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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266 participants in 1 patient group

ICP-248 in combination with azacitidine

Experimental group

Treatment:

Drug: ICP-248

Drug: Azacitidine