Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies

Summary

This is an open-label, multicenter, dose-escalation Phase 1/1b study in patients with acute myelogenous leukemia (AML)/MDS or non-Hodgkin Lymphoma (NHL), intended to investigate safety, pharmacokinetics, and the pharmacodynamic effects of FT-1101 administered via one or more intermittent dosing schedules alone and in combination with azacitidine. Once the MTD has been established for a treatment cohort, up to 20 additional patients may be enrolled in up to 4 expansion cohorts each of select populations of patients with either AML/MDS or NHL at the recommended dose for future studies to confirm safety.

Timeline

Start

2015-09

Primary completion

2019-03

Completion

2019-03

Publications

• Crymes A, Evans MG, Jeyakumar D, Lou JJ, Zhao X, Rezk SA. Acute Myeloid Leukemia (AML) With T-Cell Differentiation Arising From Chronic Myelomonocytic Leukemia (CMML). Case Rep Hematol. 2024 Dec 14;2024:5584297. doi: 10.1155/crh/5584297. eCollection 2024.

Drugs

Indications