Sumitomo Pharma America, Inc.
A phase 1/2 dose escalation / dose expansion study of Enzomenib (DSP-5336) in patients with acute leukemia.
DSP-5336-101 is a phase 1/2 open-label, dose escalation, dose expansion study in which the safety, PK, pharmacodynamics, and clinical activity of orally administered DSP-5336 will be evaluated in patients with relapsed or refractory AML, ALL, or acute leukemia of ambiguous lineage, and in selected sites and regions, in adult patients with high-risk relapsed or refractory MDS or relapsed MM. Additionally, the safety and clinical activity of orally administered DSP-5336 will be evaluated in combination with Standard-of-Care (SOC) AML treatments including: (a) the SOC nonintensive regimen (venet…
Inclusion Criteria: For patients in Phase I: 1. Have a diagnosis of relapsed or refractory AML, ALL or acute leukemia of ambiguous lineage according to World Health Organization (WHO) 2022 classification, or, in selected sites and regions, a diagnosis of MDS or MM as determined by pathology review at the treating institution, and whose disease has progressed after available standard therapies known to be active for their AML, ALL, or acute leukemia of ambiguous lineage or, in selected sites and regions, for MM or MDS. If acute leukemia patients are transformation from MDS or other hematologi…
DSP-5336 orally
Posaconazole, Voriconazole, or Fluconazole
Venetoclax orally
Gilteritinib orally
Azacitidine orally
chemotherapy