Clinical Trial 24107

• Overview

  Study Title:

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

  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.

  Objective:

  Primary Objective: Dose Escalation To assess the safety and tolerability of ICP-248 in combination with azacitidine in patients with myeloid malignancies. Dose Expansion To evaluate the preliminary efficacy of ICP-248 in combination with azacitidine in patients with myeloid malignancies. Secondary Objectives: Dose Escalation To assess the pharmacokinetic (PK) profile of ICP-248 in combination with azacitidine in patients with myeloid malignancies. To evaluate the preliminary efficacy of ICP-248 in combination with azacitidine in patients with myeloid malignancies. Dose Expansion To further evaluate the preliminary efficacy of ICP-248 in combination with azacitidine in patients with myeloid malignancies. To further assess ICP-248 PK profiles in patients with myeloid malignancies. To assess the safety profile of ICP-248 in combination with azacitidine in patients with myeloid malignancies. To evaluate the safety of posaconazole in combination with ICP-248 in the drug-drug interactions (DDI) study. To evaluate the influence of oral posaconazole on the PK profile of ICP-248 in the DDI study.

• Treatments

  Therapies:

  BCL-2 inhibitor; Chemotherapy (NOS)

  Medications:

  Azacitidine (); ICP-248 ()

• Inclusion Criteria

  Key Inclusion 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 > 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

  Key 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.

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