Nanatinostat Plus Valganciclovir in Patients With Advanced EBV+ Solid Tumours, and in Combination With Pembrolizumab in EBV+ RM-NPC

Official Title

An Open-Label, Multicentre Phase 1b/2 Study of Nanatinostat and Valganciclovir in Patients With Advanced Epstein-Barr Virus-Positive (EBV+) Solid Tumours and in Combination With Pembrolizumab in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

Summary:

This study will evaluate the safety efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive solid tumours and in combination with pembrolizumab in patients with recurrent/metastatic nasopharyngeal carcinoma

Trial Description

Primary Outcome:

• Phase 1b: Incidence of dose-limiting toxicities (DLTs)
• Phase 2: Overall response rate (ORR)

• Incidence and severity of adverse events
• Duration of response (DOR)
• Disease control rate (DCR)
• Progression-free survival (PFS)
• Overall survival (OS)
• Pharmacokinetic parameter - time to maximum plasma concentration [tmax]
• Pharmacokinetic parameter - maximum plasma concentration [Cmax]
• Pharmacokinetic parameter - area under the plasma concentration-time curve [AUC]

This is an open-label, multicenter Phase 1b/2 study evaluating nanatinostat in combination with valganciclovir alone and in combination with pembrolizumab. Nanatinostat is a selective class I HDAC inhibitor which induces EBV early lytic phase protein generation, activating (val)ganciclovir to its cytotoxic form.

The Phase 1b dose escalation portion is designed to evaluate safety and to determine the recommended Phase 2 dose (RP2D) in patients with EBV+ RM-NPC. In Phase 2, up to sixty patients with EBV+ RM-NPC will be randomized to receive nanatinostat in combination with valganciclovir at the RP2D with or without pembrolizumab, to evaluate safety, overall response rate, and potential pharmacodynamic markers. Additionally, patients with other EBV+ solid tumours will be enrolled to receive nanatinostat in combination with valganciclovir at the RP2D in a Phase 1b dose expansion cohort.

View this trial on ClinicalTrials.gov