Acute Myeloid Leukemia Clinical Trial
— TWT-202Official title:
Phase 1b/2 Clinical Study of the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Profiles of CFI-400945 as a Single Agent or in Combination With Azacitidine in Patients With AML, MDS or CMML
The purpose of this study is to test the safety of an investigational drug called CFI-400945 alone and in combination with azacitidine.
Status | Recruiting |
Enrollment | 72 |
Est. completion date | January 2026 |
Est. primary completion date | January 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta | Edmonton | Alberta |
Canada | Princess Margaret Cancer Center | Toronto | Ontario |
Hong Kong | Queen Mary Hospital | Hong Kong | |
United States | The Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
United States | City of Hope | Duarte | California |
United States | The University of Texas MD Anderson Cancer Centre | Houston | Texas |
United States | Norton Cancer Institute - Saint Matthews | Louisville | Kentucky |
United States | New York Presbyterian Weill Cornell Medical Center | New York | New York |
United States | University of California Davis Comprehensive Cancer Center | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
Treadwell Therapeutics, Inc |
United States, Canada, Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of treatment emergent AEs | The number of subjects who experience an adverse event that was possibly related to study drug | 36 months | |
Primary | Treatment emergent changes in vital signs | The number of subjects who experience changes in blood pressure, heart rate, respiratory rate, body temperature that was possibly related to study drug. | 36 months | |
Primary | Treatment emergent changes in clinical laboratory tests | The number of subjects who experience a change in laboratory parameters that was possibly related to study drug. | 36 months | |
Primary | Treatment emergent changes in physical examinations, ECOG performance status, electrocardiograms (ECGs), echocardiograms and cardiac troponins | The number of subjects who experience changes in physical examinations, performance status, ECG, troponins that were possibly related to study drug. | 36 months | |
Secondary | Composite Complete Remission Rate, CRc (complete remission + complete remission with incomplete blood count recovery + complete remission with incomplete platelet count recovery [CR + CRi + CRp]) | Response rate will be summarized by dose cohort and overall using the percent of patients in patient with AML | 36 months | |
Secondary | Overall response rate (ORR, defined as Complete remission + Marrow CR + Partial remission + Hematologic Improvement (CR + mCR+ PR + HI) | Response rate will be summarized by dose cohort and overall using the percent of patients in patients with MDS, CMML | 36 months | |
Secondary | The pharmacokinetics of CFI-400945 will be assessed through AUC. | Area under the plasma concentration (AUC) versus time curve from time 0 to time of least measurable concentration tabulated by dose group. | 36 months | |
Secondary | To assess the pharmacokinetic profile of CFI-400945 through Cmax. | Cmax will be assessed through the maximum measured plasma concentration occurring at Tmax tabulated by dose group. | 36 months | |
Secondary | To assess the pharmacokinetic profile of CFI-400945 through T1/2. | Elimination half life will be calculated and tabulated by dose group. | 36 months |
Status | Clinical Trial | Phase | |
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