Study on Nanatinostat and Valganciclovir for Advanced EBV+ Solid Tumors, and with Pembrolizumab for EBV+ Nasopharyngeal Cancer

Sponsor: Viracta Therapeutics, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05166577

Provider View

This clinical trial is testing the safety and effectiveness of a new treatment using nanatinostat and valganciclovir for patients with advanced EBV-positive solid tumors, and in combination with pembrolizumab for those with recurrent or metastatic nasopharyngeal cancer.

Patient Parameters

Program Overview

The study aims to find out if a combination of nanatinostat and valganciclovir, with or without pembrolizumab, is safe and effective for treating patients with certain types of EBV-positive cancers. Nanatinostat is a drug that helps activate valganciclovir to fight cancer cells. The trial will first determine the best dose for treatment and then test its effectiveness in a larger group of patients.

Description

This clinical trial is open to patients with advanced EBV-positive cancers and is being conducted at multiple centers. It is divided into two phases: Phase 1b and Phase 2.

In Phase 1b, the study will test different doses of nanatinostat combined with valganciclovir to find the safest and most effective dose for patients with EBV-positive nasopharyngeal cancer. Once the best dose is determined, the study will move to Phase 2, where up to 60 patients will be randomly assigned to receive either the combination of nanatinostat and valganciclovir alone or with pembrolizumab. This phase will evaluate the safety and effectiveness of the treatment and look for markers that indicate how well the treatment is working.

Additionally, patients with other types of EBV-positive solid tumors will receive nanatinostat and valganciclovir to assess the treatment's safety and effectiveness in this group as well.

Eligibility Criteria

Inclusion Criteria

  • Have recurrent or metastatic EBV-positive nasopharyngeal cancer with no curative treatment options available.
  • Have received at least one prior platinum-based chemotherapy treatment and no more than three prior treatments for nasopharyngeal cancer.
  • For Phase 1b only: Have advanced or metastatic EBV-positive non-nasopharyngeal solid tumors with no curative treatment options.
  • Have measurable disease according to standard criteria.
  • Have a performance status indicating full activity or some restriction in strenuous activities.
  • Have adequate bone marrow and liver function.

Exclusion Criteria

  • Have received anti-cancer treatment with certain drugs within the last four weeks or a period shorter than five times the drug's half-life.
  • Have active disease affecting the central nervous system.
  • Have conditions that prevent taking oral medication or affect the absorption of the study drugs.
  • Have an active infection requiring treatment.
  • Have an active autoimmune disease requiring treatment with certain medications.
  • Test positive for hepatitis B or C.

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