AMX-883 for Acute Myeloid Leukemia and Myelodysplastic Syndrome
(BRAMLIE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of the study is to assess the safety, pharmacokinetics, and preliminary efficacy of AMX-883 monotherapy in participants with acute myeloid leukaemia (AML) and high-risk myelodysplastic syndrome (MDS) and in combination with anticancer agents in participants with AML.
Are You a Good Fit for This Trial?
This trial is for adults with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) whose disease has come back or not responded to standard treatments. Participants need good kidney and liver function, be in fair physical condition, and use effective birth control.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- AMX-883
Trial Overview
The study tests a new drug called AMX-883 alone in people with AML or high-risk MDS, and also tests AMX-883 combined with other cancer drugs in people with AML. The main goals are to check safety, how the body processes the drug, and early signs of effectiveness.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Participants will receive a selected dose level for at least two escalating dose levels of AMX-883 selected from the M1A dose escalation cohort, administered in combination with posaconazole.
Participants will receive a selected dose of AMX-883 from the M1A dose escalation cohort, administered as monotherapy, under fed and fasted conditions.
Participants will receive escalating dose levels of AMX-883 administered as monotherapy.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amphista Therapeutics Ltd
Lead Sponsor
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