A Study of CFI-400945 With or Without Azacitidine in Patients With AML, MDS or CMML

Prior treatment

• Patients who have received investigational therapy, radiotherapy, immunotherapy, monoclonal antibodies, or chemotherapy within 14 days or 5 half-lives (whichever is shorter)
• Allogeneic or autologous transplant for AML with infusion of stem cells within 90 days before Cycle 1 Day 1, or on active immunosuppressive therapy for graft-versus-host disease (GVHD) or GVHD prophylaxis within 2 weeks of Cycle 1 Day 1.
• Any Grade ≥ 2 persistent non-hematological toxicity related to allogeneic transplant, such as those requiring systemic immunosuppressive therapy.

• Patients must be \>18 years of age
• For Parts 1A and 1B, the following malignancy types will be included:
  • Relapsed or refractory AML.
  • MDS, after prior hypomethylating agents.
  • CMML, with progressive disease/lack of response after hypomethylating agents
  • For Parts 1A and 1B, Patients may have relapsed or refractory disease.
• For Parts 2A and 2B, the following malignancy types will be included:
  • Relapsed or Refractory AML.
  • MDS patients should be limited to high risk disease
  • MDS or CMML should be previously untreated and patients with AML may have relapsed or refractory disease;
• Have clinically acceptable laboratory screening results (i.e., clinical chemistry, hematology, and urinalysis) within certain limits per protocol.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.