This is a Phase 1, 2-part, open-label, multicenter, first-in-human (FIH) study to assess the
safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of
TAS1553 administered orally to participants ≥18 years of age with relapsed or refractory
(R/R) acute myeloid leukemia (AML) or other myeloid neoplasms where approved therapies have
failed or for whom known life-prolonging therapies are not available. The AML population
includes de novo AML, secondary AML, and myelodysplastic syndrome (MDS)-transformed into AML.
Other myeloid neoplasms include accelerated phase myeloproliferative neoplasms (MPN), and
chronic or accelerated phase MPN-unclassifiable (MPN-U) and MDS-MPN. Blast crisis phase of
MPNs are considered secondary AML and will be included in the AML cohort.
Part 1 is a multicenter, sequential group treatment feasibility study with 1 treatment arm
and no masking (dose escalation). Part 2 is a multicenter, two-stage, multiple group, dose
confirmation study with 1 treatment arm and no masking (exploratory dose expansion).
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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