NCT05732103 · Chordia Therapeutics, Inc.
A Study of CTX-712 in Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes
What this study is about
The goal of this phase 1/2 conducted at multiple hospitals, where both patients and doctors know the treatment given, single-treatment group$1 gradually increasing doses and expansion study is to assess the safety, tolerability, how the drug moves through the body and how the drug affects the body 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 gradually increasing doses, where patients will receive ascending doses of CTX-712 to determine
View original scientific description
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).
Interventions
DRUG
CTX-712
CTX-712 will be provided as a 20 mg tablet for oral administration. Patients will take CTX-712 once or twice weekly, depending on their dose level assignment, during each 28-day cycle.
Primary outcome measures
Phase 1: Frequency of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) related to CTX-712.
Time frame: Adverse events are collected from time of informed consent through 28 days after last dose of CTX-712.
Phase 1: The maximum tolerated dose MTD.
Time frame: Dose-limiting toxicities are collected during the first treatment cycle (28 days).
MTD is the dose producing \<33% of dose-limiting toxicities.
Phase 2: Complete remission rate, defined as the proportion of patients who achieve complete remission.
Time frame: Measured from date of first dose to 28 days after last dose of CTX-712.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age ≥18 years. 2. Diagnosis of AML, HR-MDS, or high marrow blast MDS/MPN (including CMML). 3. Prior treatment history must include 1-4 prior lines of therapy. 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 days before study treatment initiation and if sexually active, agree to use a highly effective form of contraception throughout their participation during study treatment and up to 4 months after the last dose of study drug 7. Male patients with female partners of childbearing potential must, even if surgically sterilized, agree to practice effective b
Where
- Phoenix, Arizona
- Jacksonville, Florida
- Chicago, Illinois
- Rochester, Minnesota
- Rochester, New York
- Houston, Texas
- Charlottesville, Virginia
- Seattle, Washington
Collaborators
Theradex
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations