Clinical trial · Interventional
Nanatinostat Plus Valganciclovir in Advanced EBV+ Solid Tumors and in Combination With Pembrolizumab in EBV+ RM-NPC
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor Decision
Summary
Brief summary (as posted)
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
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EBV Related Carcinoma | EBV-Related Carcinoma | ONTOLOGY_EXACT | 0.98 |
| EBV-Related Gastric Carcinoma | EBV-Related Gastric Carcinoma | ONTOLOGY_EXACT | 0.98 |
| EBV-Related Leiomyosarcoma | EBV-Related Leiomyosarcoma | ONTOLOGY_EXACT | 0.98 |
| EBV-Related Sarcoma | EBV-Related Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nanatinostat | Drug | — | UNRESOLVED |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| Valganciclovir | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nanatinostat in combination with valganciclovir
- description
- Phase 1b: Nanatinostat dose escalation starting at 20 mg orally daily, 4 days per week, and valganciclovir starting at 900 mg orally daily, then Phase 2: Nanatinostat and valganciclovir at the confirmed recommended Phase 2 dose
- interventionNames
- Drug: Nanatinostat
- Drug: Valganciclovir
- type
- EXPERIMENTAL
- label
- Nanatinostat in combination with valganciclovir and pembrolizumab
- description
- Phase 2: Nanatinostat and valganciclovir at the confirmed recommended Phase 2 doses in combination with pembrolizumab 200 mg intravenous (IV) every 3 weeks
- interventionNames
- Drug: Nanatinostat
- Drug: Valganciclovir
- Drug: Pembrolizumab
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available