Study of REM-422 for AML or Higher Risk MDS
This study is testing a new oral medication called REM-422 for people aged 18 and older with acute myeloid leukemia (AML) that has come back or is resistant to treatment, or with higher-risk myelodysplastic syndromes (MDS). REM-422 works by reducing a specific protein called MYB. The main goals are to find out how safe REM-422 is, what side effects it might cause, and the highest dose that can be given safely. Researchers will also look at how well REM-422 works against the cancer. This study is currently recruiting about 100 participants.
- Study design
- This is a Phase 1, open-label study, meaning both you and your doctors will know you are receiving REM-422. It is not randomized, so you will not be assigned to a placebo or different treatment group. The study plans to enroll about 100 participants.
- What's involved
- You will take REM-422 by mouth once daily. Your participation will continue until your disease gets worse, you can't tolerate the treatment, or you choose to stop.
- Compensation
- Not stated in the trial record.
- Follow-up
- The frequency and severity of side effects will be measured for 24 months. The maximum tolerated dose will be assessed at the end of Cycle 1 (each cycle is 28 days) for approximately 24 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of REM-422 in Patients With AML or Higher Risk MDS
At a glance
Conditions
Where it's being run
9 sites across 6 statesStudy leadership
- Christopher Bowden, MD · STUDY_CHAIR · Remix Therapeutics
Who to contact
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What this trial measures
- Frequency and severity of Treatment Emergent Adverse Events (TEAEs)24 months
Frequency and severity of Treatment Emergent Adverse Events (TEAEs) will be evaluated according to the NCI-CTCAE version 5.0 and number of participants with Dose Limiting Toxicities will be assessed to determine Safety and Tolerability of REM-422 from the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to approximately 24 months.
- Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D)Assessed at the end of Cycle 1 (each cycle is 28 days) for each participant for approximately 24 months
Frequency and severity of Treatment Emergent Adverse Events (TEAEs) will be evaluated according to the NCI-CTCAE version 5.0 and the number of participants with Dose Limiting Toxicities will be assessed from the date of first dose of REM-422 until the date of first documented progression or date of death from any cause, whichever came first, assessed up to approximately 24 months