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

Required: FLT3 itd

Required: FLT3 tkd/d835

Required: FLT3 tkd/i836

Required: KMT2A (MLL) fusion

Required: NPM1 mutation

Must have received: standard therapies — disease has progressed after available standard therapies known to be active

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

Must have received: hypomethylating agent — MDS

MDS ... have exhausted available standard therapies including at least 2 cycles of treatment with HMA

Must have received: proteasome inhibitor — MM

treatment with a minimum of 3 prior anti-myeloma regimens including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody (mAb)

Must have received: immunomodulatory drug — MM

treatment with a minimum of 3 prior anti-myeloma regimens including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody (mAb)

Must have received: anti-CD38 monoclonal antibody — MM

treatment with a minimum of 3 prior anti-myeloma regimens including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody (mAb)

Cannot have received: menin inhibitor

Must not have received prior treatment with a menin inhibitor

Cannot have received: antineoplastic agents

Exception: except hormonal therapies as adjuvant maintenance for breast or prostate cancers if a patient is taking before starting study treatment, and hydroxyurea given for controlling blast cells

Received antineoplastic agents (except hormonal therapies as adjuvant maintenance for breast or prostate cancers if a patient is taking before starting study treatment, and hydroxyurea given for controlling blast cells) or other investigational treatment within 7 days or 5 half-lives, whichever is shortest, prior to the first dose of DSP-5336

Cannot have received: systemic calcineurin inhibitors

Received systemic calcineurin inhibitors within 2 weeks prior to the first dose of DSP 5336

Cannot have received: systemic calcineurin inhibitors

Received systemic calcineurin inhibitors within 4 weeks prior to the first dose of DSP-5336

Cannot have received: CAR-T cell therapy

underwent HSCT or chimeric antigen receptor cell (CAR-T) therapy or other modified T-cell therapy within 60 days prior to the first dose of DSP-5336. For clinical sites in the UK, underwent CAR-T therapy or other modified T-cell therapy within 6 months prior to the first dose of DSP-5336

Cannot have received: hematopoietic stem cell transplant

underwent HSCT or chimeric antigen receptor cell (CAR-T) therapy or other modified T-cell therapy within 60 days prior to the first dose of DSP-5336

Cannot have received: donor lymphocyte infusion

Received a donor lymphocyte infusion within 28 days prior to the first dose of DSP-5336