Novel BET Inhibitor PLX51107 for Steroid-Refractory Acute GVHD

Status Completed

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. ;

Study Design

Related Conditions & MeSH terms

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

Clinical Trial Details

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

View Details

See also
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