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

Key Inclusion Criteria:

   - 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

Key Exclusion Criteria:

   - 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