A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1)

A phase 1/2 dose escalation / dose expansion study of Enzomenib (DSP-5336) in patients with acute leukemia. Lead Sponsor: Sumitomo Pharma America, Inc. Start Date: 2022-02-28 Primary Completion: 2027-06-30

• : 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 hematologic malignancies, patients need to receive available standard therapies as acute leukemia after AML transformation and before enrolling this trial. In regions or countries where required by regulatory authorities, participants must have a documented KMT2A (MLL) fusion or NPM1 mutation, including those with coexisting FLT3 genomic alterations and/or IDH1/2 mutation. Participants who are candidates for stem cell transplantation must have been offered this therapeutic option. For patients with MDS (selected sites and regions): 1. Patients with MDS must have bone marrow blasts ≥ 5% 2. Patients with MDS must have relapsed or refractory disease and have exhausted available standard therapies including at least 2 cycles… Data sourced from ClinicalTrials.gov. Trial details may change — always check the primary source before clinical decisions.

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.