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.
Participants with relapsed or refractory AML who have failed all available standard therapies or relapsed or refractory high-risk MDS with BM blasts 10-19%
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Adequate washout from prior therapies
Adequate kidney and liver function
Diagnosis of acute promyelocytic leukaemia or chronic myelogenous leukaemia in blast crisis
Clinically active central nervous system (CNS) leukaemia
Receiving immunosuppressive therapy post HSCT
History of another malignancy that is active, progressing, or has required systemic treatment within the past 2 years