A Study of CFI-400945 With or Without Azacitidine in Patients With AML, MDS or CMML (TWT-202)
Acute Myeloid Leukemia, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Polo-like kinase 4, PLK4, serine/threonine kinase Polo-like kinase 4, CFI-400945, 945, Polo-Like Kinase 4 inhibitors/antagonists, hematologic malignancies, PLK-4, UHN, University Health Network, Treadwell, Treadwell Therapeutics, Treadwell Tx
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- City of HopeRecruiting
- University of California Davis Comprehensive Cancer CenterRecruiting
- Norton Cancer Institute - Saint Matthews
- New York Presbyterian Weill Cornell Medical CenterRecruiting
- The Ohio State University Comprehensive Cancer CenterRecruiting
- The University of Texas MD Anderson Cancer CentreRecruiting
- University of AlbertaRecruiting
- Princess Margaret Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
1A: Monotherapy escalation and expansion
2A: Combination escalation and expansion
Dose escalation and expansion arm with CFI-400945
Dose escalation and expansion arm with CFI-400945 and azacitidine