A Study of CTX-712 in Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysp
The goal of this phase 1/2 multicenter, open-label, single-arm dose escalation and expansion study is to assess the safety, tolerability, pharmacokinetic and pharmacodynamic profile of CTX-712 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and higher risk myelodysplastic syndromes (HR-MDS), or
| Condition(s) | Acute Myeloid Leukemia, Myelodysplastic Syndromes |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | The goal of this phase 1/2 multicenter, open-label, single-arm dose escalation and expansion study is to assess the safety, tolerability, pharmacokinetic and pharmacodynamic profile of CTX-712 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and higher risk myelodysplastic syndromes (HR-MDS), or MDS/MPN (including CMML). The phase 1 part of the study consists of sequential standard 3 + 3 dose escalation, where patients will receive ascending doses of CTX-712 to determine the recommended phase 2 dose (RP2D) for further clinical development. This is followed by initial expansion cohorts in AML and/or HR-MDS where patients will be treated with CTX-712 at the RP2D to gain further confidence in the selected dose level. Additional expansion cohorts may be initiated if cons |
| Who can participate | Inclusion criteria: 1. Age ≥18 years. 2. Diagnosis of AML, HR-MDS, or high marrow blast MDS/MPN (including CMML). Note: Only patients with AML and HR-MDS are eligible in the expansion cohorts. 3. Prior treatment history must include 1-4 prior lines of therapy. Note: 1-3 prior lines are allowed for patients in the expansion cohorts. 4. Adequate organ function evidenced by the following laboratory values: Creatinine clearance (CL) ≥60 mL/min * Total serum bilirubin \< 1.5 × upper limit of normal (ULN) * Alanine aminotransferase (ALT) * Aspartate aminotransferase(AST) \< 2.5 × ULN * White blood cell count at the time of the first dose \<10 k/μL 5. Eastern Cooperative Oncology Group performance status ≤2. 6. Female patients of childbearing potential must have a negative pregnancy test within 7 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Chordia Therapeutics, Inc. |
| Locations | Phoenix, Arizona, United States; Jacksonville, Florida, United States; Chicago, Illinois, United States; Rochester, Minnesota, United States; Rochester, New York, United States; Houston, Texas, United States (+2 more sites) |
| Start date | 2023-04-25 |
| NCT ID | NCT05732103 |
| Official listing | https://clinicaltrials.gov/study/NCT05732103 |