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
Single group
AMX-883
DrugAMX-883 will be administered orally.
Posaconazole
DrugPosaconazole tablets will be administered orally.
Number of participants with adverse events (AEs), treatment-emergent adverse events (TEAEs), adverse events of special interests (AESIs) and serious adverse events (SAEs)
To determine the safety and tolerability of AMX-883 in participants with relapsed or refractory AML and high-risk MDS when administered as monotherapy and in combination with posaconazole.
Number of participants with dose limiting toxicities (DLTs)
To determine the maximum tolerated dose (MTD)/optimal biological dose (OBD) and the recommended dose for expansion (RDE) of AMX-883 in participants with relapsed or refractory AML and high-risk MDS when administered as monotherapy and in combination with posaconazole.
Maximum plasma concentration (Cmax)
To characterise the PK (Cmax) parameters of AMX-883 after a single dose and at steady state when administered as monotherapy and in combination with posaconazole and to characterise the effect of a high-fat meal on the PK (Cmax) of AMX-883.
Minimum plasma concentration (Cmin)
To characterise the PK (Cmin) parameters of AMX-883 after a single dose and at steady state when administered as monotherapy and in combination with posaconazole and to characterise the effect of a high-fat meal on the PK (Cmin) of AMX-883.
Time to Cmax (Tmax)
To characterise the PK (Tmax) parameters of AMX-883 after a single dose and at steady state when administered as monotherapy and in combination with posaconazole and to characterise the effect of a high-fat meal on the PK (Tmax) of AMX-883.
Terminal plasma half-life (t½λz)
To characterise the PK (t½λz) parameters of AMX-883 after a single dose and at steady state when administered as monotherapy and in combination with posaconazole and to characterise the effect of a high-fat meal on the PK (t½λz) of AMX-883.
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