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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients must be >18 years of age. 2. For Parts 1A and 1B, the following malignancy types will be included: 1. Relapsed or refractory AML. 2. MDS, after prior hypomethylating agents. 3. CMML, with progressive disease/lack of response after hypomethylating agents. For Parts 1A and 1B, Patients may have relapsed or refractory disease. 3. For Parts 2A and 2B, the following malignancy types will be included: 1. Relapsed or Refractory AML. 2. MDS patients should be limited to high risk disease. 3. MDS or CMML should be previously untreated and patients with AML may have relapsed or refractory disease; 4. Have clinically acceptable laboratory screening results (i.e., clinical chemistry, hematology, and urinalysis) within certain limits per protocol. 5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

1. Patients who have received investigational therapy, radiotherapy, immunotherapy, monoclonal antibodies, or chemotherapy within 14 days or 5 half-lives (whichever is shorter) 2. 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. 3. Any Grade ≥ 2 persistent non-hematological toxicity related to allogeneic transplant, such as those requiring systemic immunosuppressive therapy.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04730258
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Treadwell Therapeutics, Inc
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Gautam Borthakur, MD
Principal Investigator Affiliation	The University of Texas MD Anderson Cancer Centre
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Canada, Hong Kong, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Acute Myeloid Leukemia, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, AML, MDS, CMML

Additional Details

This study will be evaluating the safety and tolerability of CFI-400945 in subjects with Acute Myeloid Leukemia, Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia. The study is designed to build on encouraging data from another study and to obtain further safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) data of CFI-400945.

Arms & Interventions

Arms

Experimental: 1A: Monotherapy escalation and expansion

Dose escalation and expansion arm with CFI-400945

Experimental: 2A: Combination escalation and expansion

Dose escalation and expansion arm with CFI-400945 and azacitidine

Interventions

Drug: - CFI-400945

The starting dose is 32 mg/day for escalation arms and the recommended starting dose for the expansion arms.

Drug: - Azacitidine

Azacitidine will be given at its labeled dose and schedule

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

City of Hope, Duarte, California

Status

Recruiting

Address

City of Hope

Duarte, California, 91010

Site Contact

Paul Koller

[email protected]

+1-416-455-7510

Sacramento, California

Status