A Study of CTX-712 in Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes
Eligible age
18+ yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
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About this study
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 considered necessary. After RP2D is determined, Drug-Drug-Interaction cohorts will be started. The phase 2 part of the study will commence after the RP2D has been identified and confirmed and will evaluate therapeutic activity in R/R AML or R/R HR-MDS, in addition to confirmation of the safety profile.
Sponsor: Chordia Therapeutics, Inc.
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 1. Diagnosis of acute promyelocytic leukemia.
- ✕ 2. Isolated extramedullary relapse (phase 2 only).
- ✕ 3. Active central nervous system (CNS) leukemia.
- ✕ 4. History of other malignancy.
- ✕ 5. Any of the following cardiopulmonary abnormalities:
- ✕ 1. Myocardial infarction within six months prior to registration.
- ✕ 2. New York Heart Association Class III or IV heart failure or known left ventricular ejection fraction \< 50%.
- ✕ 3. A history of familial long QT syndrome.
Where it's recruiting
Source: ClinicalTrials.gov · NCT05732103 · last updated 2026-04-13