Trial results for NCT05166577, evaluating nanatinostat in combination with valganciclovir, and in combination with pembrolizumab, were posted on ClinicalTrials.gov on 2025-02-24. The Phase 1b study, which investigated these regimens in patients with advanced EBV-positive solid tumors and recurrent/metastatic nasopharyngeal carcinoma, was TERMINATED. Safety data indicated 2 dose-limiting toxicities (DLTs) in one of the evaluated dose cohorts.
Background
This study focused on Epstein-Barr virus (EBV)-positive solid tumors, including Nasopharyngeal Carcinoma, EBV-Related Gastric Carcinoma, EBV-Related Leiomyosarcoma, EBV Related Carcinoma, and EBV-Related Sarcoma. The primary objective was to evaluate the safety and efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive solid tumors, and in combination with pembrolizumab in patients with recurrent/metastatic nasopharyngeal carcinoma.
Trial design
The completed study, NCT05166577, was a Phase 1b trial that enrolled 26 participants. The interventions included nanatinostat, valganciclovir, and pembrolizumab. The trial was designed to assess the safety and efficacy of these combinations in the specified EBV-positive tumor types. The overall status of the trial is TERMINATED.
Key results
The incidence of Dose-Limiting Toxicities (DLTs) was reported across several dose cohorts:
- In Dose Cohort 1, 0 Participants experienced DLTs.
- In Dose Cohort 2, 0 Participants experienced DLTs.
- In Dose Cohort 3, 0 Participants experienced DLTs.
- In Dose Cohort 4, 0 Participants experienced DLTs.
- In Dose Cohort 5, 0 Participants experienced DLTs.
- In Dose Cohort 6, 2 Participants experienced DLTs.
- In Dose Cohort 7, 0 Participants experienced DLTs.
The incidence of Adverse Events was also reported for several cohorts:
- In Dose Cohort 1, 3 Participants experienced adverse events.
- In Dose Cohort 2, 4 Participants experienced adverse events.
- In Dose Cohort 3, 3 Participants experienced adverse events.
- In Dose Cohort 4, 3 Participants experienced adverse events.
- In Dose Cohort 5, 4 Participants experienced adverse events.
What this means
The termination of this Phase 1b trial, coupled with the observation of 2 dose-limiting toxicities in one cohort, suggests that safety concerns may have played a role in the decision to halt the study. While other cohorts showed no DLTs, the presence of these events in a dose-escalation setting is a critical finding. The reported incidence of adverse events provides further insight into the safety profile of the investigated combinations. The termination indicates that further development of these specific regimens in this trial design will not proceed.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05166577, titled "Nanatinostat Plus Valganciclovir in Advanced EBV+ Solid Tumors and in Combination With Pembrolizumab in EBV+ RM-NPC," were posted on 2025-02-24 on clinicaltrials.gov.