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CTX-712 for Relapsed/Refractory AML and Higher-Risk MDS

This study is testing a new oral medication called CTX-712 for people with acute myeloid leukemia (AML) or higher-risk myelodysplastic syndromes (MDS) that have returned or not responded to previous treatments. The study aims to find the safest and most effective dose of CTX-712. You would take CTX-712 as a pill once or twice a week. Researchers will be looking at how safe the drug is and if it can lead to a complete remission (when signs of cancer disappear). This study is currently open to adults aged 18 and older who have had 1-4 prior treatments for their condition.

Study design
This is a Phase 1/2, multicenter, open-label study with approximately 225 participants. It is a single-arm study, meaning all participants will receive CTX-712.
What's involved
Patients will take CTX-712 once or twice weekly during each 28-day cycle. Safety events will be collected from the time of consent through 28 days after the last dose.
Compensation
Not stated in the trial record.
Follow-up
Adverse events are collected through 28 days after the last dose of CTX-712. Complete remission rates are measured from the first dose to 28 days after the last dose.

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NCT05732103

A Study of CTX-712 in Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes

Recruiting
PHASE1Ages 18+InterventionalTreatment
Chordia Therapeutics, Inc.
~225 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:CTX-712

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1: Frequency of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) related to CTX-712.
Measured over Adverse events are collected from time of informed consent through 28 days after last dose of CTX-712.
+2 more outcomes measured

Conditions

Acute Myeloid Leukemia
Myelodysplastic Syndromes

Explore related trials

Acute Myeloid LeukemiaMiller-Dieker SyndromeMyelodysplastic Syndrome

Where it's being run

8 sites across 8 states
Arizona1
Florida1
Illinois1
Minnesota1
New York1
Texas1
Virginia1
Washington1

Study leadership

  • Guillermo Garcia-Manero, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Laurie F Graham, RN, MSN
[email protected]
(609) 608-2152
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 barrier contraception during the entire study treatment period and through four months after the last dose of study drug, or practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant.

What this trial measures

  • Phase 1: Frequency of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) related to CTX-712.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.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.Measured from date of first dose to 28 days after last dose of CTX-712.