Clinical Trial 23594

• Overview

  Study Title:

  A Phase 1b Open-Label Study to Evaluate the Safety and Tolerability of Eganelisib as Monotherapy and in Combination with Cytarabine in Patients with Relapsed/Refractory Acute Myeloid Leukemia

  Summary:

  The goal of this clinical research study is to find out if the study treatments are safe and will help control relapsed/refractory acute myeloid leukemia AML [r/r AML] or higher-risk myelodysplastic syndromes [HR-MDS]. Relapsed/refractory means that patient either did not respond to most recent treatment or the disease has returned. The two study treatments are eganelisib alone and in combination with cytarabine.

  Objective:

  Part 1 Monotherapy and Combination Dose Escalation (DE): Primary Objectives: Assess the safety and tolerability of eganelisib administered as monotherapy and in combination with cytarabine. Determine the recommended dose for expansion (RDE) of eganelisib as monotherapy and in combination with cytarabine. Secondary Objectives: Evaluate the preliminary clinical activity of eganelisib administered as monotherapy and in combination with cytarabine. Characterize the plasma pharmacokinetics (PK) of eganelisib administered as monotherapy and in combination with cytarabine. Combination DE ONLY: Characterize the plasma PK of cytarabine in combination with eganelisib. Part 2 Dose Optimization (OPT): Primary Objective: Evaluate preliminary clinical activity of eganelisib administered as monotherapy and in combination with cytarabine. Secondary Objectives: Assess the safety and tolerability of eganelisib administered as monotherapy and in combination with cytarabine. Determine the recommended Phase 2 dose (RP2D) of eganelisib administered as monotherapy and in combination with cytarabine. Evaluate further the preliminary clinical activity of eganelisib administered as monotherapy and in combination with cytarabine. Measure plasma concentrations of eganelisib and determine model-based PK parameters.

• Treatments

  Therapies:

  Chemotherapy (NOS); Immunotherapy

  Medications:

  Cytarabine (Cytosine Arabinoside); Eganelisib ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Pathological diagnosis of either: AML according to World Health Organization (WHO) 2022 revised criteria per the local pathology report and with ≥10% bone marrow blasts (acute promyelocytic leukemia is excluded but secondary AML (including "treated secondary AML" and treatment-related AML can be included); Higher-risk (IPSS-R Intermediate, High or Very High Risk at time of study entry) myelodysplastic syndromes (HR-MDS) according to WHO 2022 revised criteria per the local pathology report and with ≥10% bone marrow blasts.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
  • Adequate hepatic and renal function measured within 7 days prior to the first dose of eganelisib.
  • Other criteria apply

• Exclusion Criteria

  Key Exclusion Criteria:
  • Autologous or allogeneic stem cell transplant within 6 months prior to Cycle 1 Day 1.
  • Receiving immunosuppressants (eg, cyclosporin) or systemic steroids (except for steroid use as cortisol replacement therapy in documented adrenal insufficiency) or low-dose steroids with a maximum of an equivalent of 10mg prednisone/day.
  • Active fungal disease or uncontrolled infection of any kind; patients receiving antibiotic, antifungal or antiviral treatment must be afebrile and hemodynamically stable for >72 hours prior to treatment
  • WBC count >25 × 10^9/L measured within 7 days prior to the first dose of eganelisib (hydroxyurea is permitted to decrease the WBC count).
  • Presence of a clinically significant non-hematologic toxicity of prior therapy that has not resolved to Grade ≤1 or Baseline, whichever is worst, as determined by NCI CTCAE v 5.0, except alopecia or skin pigmentation. Fatigue and neuropathy must have resolved to Grade ≤2.
  • Other criteria apply.

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