A Phase 2a cohort expansion study to assess the safety, tolerability, and preliminary efficacy of CXD101 in patients with advanced solid-organ cancer expressing HR23B or lymphoma.

ABSTRACT:

Background

This Phase 2a dose expansion study was performed to assess the safety, tolerability and preliminary efficacy of the maximum tolerated dose of the oral histone de-acetylase (HDAC) inhibitor CXD101 in patients with relapsed / refractory lymphoma or advanced solid organ cancers and to assess HR23B protein expression by immunohistochemistry as a biomarker of HDAC inhibitor sensitivity.

Methods

Patients with advanced solid-organ cancers with high HR23B expression or lymphomas received CXD101 at the recommended phase 2 dose (RP2D). Key exclusions: corrected QT > 450 ms, neutrophils < 1.5 × 10⁹/L, platelets < 75 × 10⁹/L, ECOG > 1. Baseline HR23B expression was assessed by immunohistochemistry.

Results

Fifty-one patients enrolled between March

SUBMITTER: Booth SW 

PROVIDER: S-EPMC8306282 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature