This study is an ascending multiple dose escalation clinical trial. It is primarily intended to evaluate the safety and tolerability of FHD-286 when administered orally to subjects with advanced hematologic malignancies, specifically R/R AML and R/R MDS. This dose escalation study will allow for the determination of the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) of FHD-286 in patients with advanced hematologic malignancies. This study will also evaluate the PK/PD profiles of multiple dose administration of FHD-286 and provide a preliminary assessment of antitumor activity in subjects with R/R AML and R/R MDS as well as other associated hematologic malignancies.~The data from this study in subjects with advanced hematologic malignancies, including safety, tolerability, PK/PD findings, and antitumor activity, will form the basis for subsequent clinical development of FHD-286.
This Phase 1, multicenter, open-label, dose escalation study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of FHD-286 oral monotherapy in subjects with advanced hematologic malignancies, specifically relapsed or refractory (R/R) acute myeloid leukemia (AML) or R/R myelodysplastic syndromes (MDS).