Nanatinostat Plus Valganciclovir in Advanced EBV+ Solid Tumors and in Combination With Pembrolizumab in EBV+ RM-NPC
Reason given: Sponsor Decision
Key facts
- Where
- Aurora, Houston, and Stanford, United StatesSee the 3 sites
- Phase
- Phase 1
Where in United States
- University of Colorado HospitalAurora, United StatesNo longer taking part
- University of Texas - MD Anderson Cancer CenterHouston, United StatesNo longer taking part
- Stanford Cancer CenterStanford, United StatesNo longer taking part
Trial details
- Who runs it
- Viracta Therapeutics, Inc.
- Trial code
- NCT05166577
- Record updated
- 12 March 2025
- Original description
This study will 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 carcinomaRead full original descriptionShow less
Open-Label Multicenter Phase 1b/2 Study of Nanatinostat + Valganciclovir in Patients With Advanced Epstein-Barr Virus-Positive Solid Tumors and in Combination With Pembrolizumab in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
This study will 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
Inclusion: Recurrent or metastatic EBV+ nasopharyngeal carcinoma (RM-NPC) for whom no potentially curative options are available, who have received at least 1 prior line of platinum-based chemotherapy and no more than 3 prior lines of therapy for RM-NPC; Phase 1b exploratory proof-of-concept cohort only: Advanced/metastatic EBV+ non-NPC solid tumors with no available curative therapies; Measurable disease per RECIST v1.1; ECOG performance status 0 or 1; Adequate bone marrow and liver function.
Exclusion: Anti-tumor treatment with cytotoxic drugs, biologic therapy, immunotherapy, or other investigational drugs within 4 weeks or >5 half-lives, whichever is shorter; Active CNS disease; Inability to take oral medication, malabsorption syndrome or any other gastrointestinal condition (nausea, diarrhea, vomiting) that may impact the absorption of nanatinostat and valganciclovir; Active infection requiring systemic therapy; Active autoimmune disease that has required systemic therapy with modifying agents, corticosteroids, or immunosuppressive agents; Positive hepatitis B or hepatitis C.