A Study of TAS1553 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML) and Other Myeloid Neoplasms
Status:
Recruiting
Trial end date:
2023-08-31
Target enrollment:
Participant gender:
Summary
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).