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A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients with Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation
Phase 1 dose escalation will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of SNDX-5613 in patients with acute leukemia. In Phase 2, patients will be enrolled in 3 indication-specific expansion cohorts to determine the efficacy, short- and long-term safety, and tolerability of SNDX-5613.
The primary objectives of Phase 1 are to determine the safety, tolerability, MTD, and RP2D of SNDX-5613 in patients with R/R acute leukemia; and to characterize the PK parameters of SNDX-5613. The primary objectives of Phase 2 are to evaluate short- and long-term safety and tolerability of SNDX-5613; and to assess the CR rate (CR+CRh).