ZE46-0134 for Relapsed or Refractory AML with Gene Mutations
This study is testing a new oral medication called ZE46-0134 for adults with acute myeloid leukemia (AML) that has come back or hasn't responded to previous treatments. Specifically, it's for those whose AML has certain gene changes (FLT3 or spliceosome mutations). The main goal is to see how safe ZE46-0134 is and what dose works best. Researchers will also look at how the body handles the drug (pharmacokinetics), its effects on the disease (pharmacodynamics), and if it helps improve the condition. The study is currently recruiting up to 150 participants, but its overall status is unclear.
- Study design
- This is a Phase 1, open-label (meaning you and your doctors will know what treatment you're receiving), multicenter study with two parts: dose escalation and dose expansion, involving up to 150 participants.
- What's involved
- You would take ZE46-0134 oral capsules once daily for up to 24 cycles (each 28 days long), with potential for longer treatment if you are benefiting.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored from the start of treatment until the end of treatment, which could be up to 24 cycles (28 days each).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Dose Escalation and Expansion Study to Evaluate the Safety, PK, PD and Efficacy of ZE46-0134 in Adults With FLT3 Mutated or Spliceosome Mutated Relapsed or Refractory Acute Myeloid Leukemia
At a glance
Conditions
Where it's being run
23 sites across 15 statesStudy leadership
- Carolyn Grove, Prof · PRINCIPAL_INVESTIGATOR · Linear Clinical Research
Who to contact
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What this trial measures
- The incidence of DLTsFrom baseline to the End of Treatment (EOT) (Max 24 cycles, 28 days each)
To determine the maximum tolerated dose or biologically effective dose of ZE46-0134 in adults with FLT3 and spliceosome mutated relapsed and refractory AML.