Amphista Therapeutics Ltd
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.
This is a modular, Phase 1, open-label, multi-centre dose-escalation study investigating AMX-883 in participants with relapsed/refractory AML and high-risk MDS. The study comprises Module 1, which will evaluate AMX-883 as monotherapy and in combination with posaconazole. Module 1 consists of three parts: * Part A consists of the monotherapy dose escalation cohorts and investigation of the food-effect at selected dose(s). * Part B consists of AMX-883 in combination with posaconazole dose escalation cohorts. Other modules may be added by protocol amendment. The study aims to establish optimal…
Inclusion Criteria: * 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 * Female participants of childbearing potential must use highly effective contraception, and male participants must agree to use barrier contraception and avoid sperm donation for at least 120 days after last dose * If enrolled in M1B: Participant must have no documented co…
AMX-883 will be administered orally.
Posaconazole tablets will be administered orally.
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