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

  • STATUS
    Recruiting
  • End date
    Mar 5, 2025
  • participants needed
    88
  • sponsor
    Viracta Therapeutics, Inc.
Updated on 5 June 2022
measurable disease
carcinoma
chemotherapy regimen
platinum-based chemotherapy
nasopharyngeal carcinoma
metastatic nasopharyngeal carcinoma

Summary

This study will evaluate the safety 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

Description

This is an open-label, multicenter Phase 1b/2 study evaluating nanatinostat in combination with valganciclovir alone and in combination with pembrolizumab. Nanatinostat is a selective class I HDAC inhibitor which induces EBV early lytic phase protein generation, activating (val)ganciclovir to its cytotoxic form.

The Phase 1b dose escalation portion is designed to evaluate safety and to determine the recommended Phase 2 dose (RP2D) in patients with EBV+ RM-NPC. In Phase 2, up to sixty patients with EBV+ RM-NPC will be randomized to receive nanatinostat in combination with valganciclovir at the RP2D with or without pembrolizumab, to evaluate safety, overall response rate, and potential pharmacodynamic markers. Additionally, patients with other EBV+ solid tumors will be enrolled to receive nanatinostat in combination with valganciclovir at the RP2D in a Phase 1b dose expansion cohort.

Details
Condition Nasopharyngeal Carcinoma, EBV-Related Gastric Carcinoma, EBV-Related Leiomyosarcoma, EBV Related Carcinoma, EBV-Related Sarcoma
Treatment Pembrolizumab, Valganciclovir, Nanatinostat
Clinical Study IdentifierNCT05166577
SponsorViracta Therapeutics, Inc.
Last Modified on5 June 2022

Eligibility

Yes No Not Sure

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
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 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
Clear my responses

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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