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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Acute Myeloid Leukemia, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, AML, MDS, CMML

In brief

The purpose of this study is to test the safety of an investigational drug called CFI-400945 alone and in combination with azacitidine.

Key facts

Study ID

NCT04730258

Run by

Treadwell Therapeutics, Inc

People needed

72

Starts

2021-04-16

Expected to finish

2026-01-01

Last updated by the study team

2025-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• City of Hope — Duarte, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• Norton Cancer Institute - Saint Matthews — Louisville, Kentucky, United States
• New York Presbyterian Weill Cornell Medical Center — New York, New York, United States
• The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• The University of Texas MD Anderson Cancer Centre — Houston, Texas, United States
• University of Alberta — Edmonton, Alberta, Canada
• Princess Margaret Cancer Center — Toronto, Ontario, Canada
• Queen Mary Hospital — Hong Kong, Hong Kong

Full record on ClinicalTrials.gov

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