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

NCT05166577 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-03-12

Study results available
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Summary

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

  • Nasopharyngeal Carcinoma
  • EBV-Related Gastric Carcinoma
  • EBV-Related Leiomyosarcoma
  • EBV Related Carcinoma
  • EBV-Related Sarcoma

Interventions

DRUG

Nanatinostat

Phase 1b: Nanatinostat dose escalation starting at 20 mg orally daily, 4 days per week, then Phase 2: Nanatinostat at the confirmed recommended Phase 2 dose

DRUG

Valganciclovir

Phase 1b: Valganciclovir starting at 900 mg orally daily, then Phase 2: Valganciclovir at the confirmed recommended Phase 2 dose

DRUG

Pembrolizumab

Phase 2: Pembrolizumab (anti-PD-1) dosed at 200 mg intravenous (IV) every 3 weeks

Sponsors & Collaborators

  • Viracta Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Darrel P Cohen, MD, PhD · Viracta Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-08
Primary Completion
2024-10-30
Completion
2025-01-10
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Hong Kong
  • Malaysia
  • Singapore
  • South Korea
  • Taiwan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05166577 on ClinicalTrials.gov