Novel BET Inhibitor PLX51107 for Steroid-Refractory Acute GVHD

Acute Graft Versus Host Disease Clinical Trial

Official title: A Single Arm, Open Label, Phase 1b/2 Study of Novel BET Inhibitor PLX51107 for Steroid-Refractory Acute GVHD

Status Terminated

Clinical Trial Summary

This phase Ib/II trial studies the side effects of PLX51107 in treating steroid-refractory acute graft versus host disease (GVHD). PLX51107 is a novel, potent non-benzodiazepine structured small molecule BET inhibitor with a unique binding mode selective for BRD4 inhibition and a more tolerable side effect profile. PLX51107 may work better in treating steroid-refractory acute GVHD.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To evaluate the safety and tolerability of BRD4 inhibitor PLX51107 (PLX51107) as a single agent for allogeneic transplant recipients with steroid-refractory acute graft versus host disease (GVHD).

II. To assess the pharmacokinetic (PK) and pharmacodynamic (PD) of orally administered PLX51107 in steroid-refractory acute GVHD patients.

SECONDARY OBJECTIVE:

I. To evaluate the preliminary efficacy of PLX51107 in steroid-refractory acute GVHD patients.

OUTLINE:

Patients receive BRD4 inhibitor PLX51107 orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then up to 6 months. ;

Related Conditions & MeSH terms

• Acute Graft Versus Host Disease
• Graft vs Host Disease
• Steroid Refractory Graft Versus Host Disease

• NCT number: NCT04910152
• Study type: Interventional
• Source: Ohio State University Comprehensive Cancer Center
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: April 19, 2022
• Completion date: September 28, 2023