AUGMENT-101: This phase I/II study is assessing the best dose level, safety and effectiveness of a new drug (SNDX-5613) in people with acute leukaemiaA 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

Summary

This study has two phases. Phase 1 (Dose escalation), will consist of six sequential cohorts of escalating dose levels of SNDX-5613 (administered orally) to identify the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D). Participants will be enrolled in one of six dose-escalation arms. Arm A: participants not receiving any strong CYP3A4 inhibitor/inducers or fluconazole. Arm B: Participants receiving any strong CYP3A4 inhibitors for antifungal prophylaxis. Arm C: participants receiving SNDX-5613 and cobicistat. Arm D: participants receiving fluconazole for antifungal prophylaxis. Arm E: Participants not receiving any weak, moderate, or strong CYP3A4 inhibitors/inducers. Arm F: participants receiving isavuconazole for antifungal prophylaxis. Phase 2 of the study involves participants being enrolled in 3 disease-specific expansion cohorts.