A Clinical Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Abexinostat in Chinese Patients

Summary

This is an open-label, non-randomized clinical study to evaluate the pharmacokinetic (PK) profiles, safety, tolerability and preliminary efficacy of oral abexinostat monotherapy in patients with non-Hodgkin's lymphoma who have failed standard of care, and thereby to determine the pharmacokinetic (PK) parameters, the maximum tolerated dose (MTD), and the recommended phase 2 dose (RP2D) of the oral monotherapy of abexinostat.

Timeline

Start

2020-01-08

Primary completion

2024-12-30

Completion

2025-11-30

Publications

• Gui L, Xie Z, Qin Y, Liu P, Yang J, Chen X, Li Z, Tao R, Shi Y. Safety, pharmacokinetics, and efficacy of abexinostat, an novel histone deacetylase inhibitor, in Chinese patients with relapsed/refractory B cell non-Hodgkin lymphoma: a Phase 1 study. BMC Cancer. 2025 May 30;25(1):967. doi: 10.1186/s12885-025-14370-y.

Drugs

Indications