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

Part of paid clinical trials in Stanford, California.

Sponsor
Viracta Therapeutics, Inc.
Study ID
NCT05166577
Phase
PHASE1
Status
Terminated

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nanatinostat — DRUG
    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
  • Valganciclovir — DRUG
    Phase 1b: Valganciclovir starting at 900 mg orally daily, then Phase 2: Valganciclovir at the confirmed recommended Phase 2 dose
  • Pembrolizumab — DRUG
    Phase 2: Pembrolizumab (anti-PD-1) dosed at 200 mg intravenous (IV) every 3 weeks

Study Details

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

Key Dates

Start date
Oct 8, 2021
Status verified
Feb 2025
Primary completion
Oct 30, 2024
Completion
Jan 10, 2025

Study Design

Enrollment
26 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nanatinostat in combination with valganciclovir
    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
  • Experimental: Nanatinostat in combination with valganciclovir and pembrolizumab
    Phase 2: Nanatinostat and valganciclovir at the confirmed recommended Phase 2 doses in combination with pembrolizumab 200 mg intravenous (IV) every 3 weeks

Primary Outcome Measure

Phase 1b: Incidence of Dose-Limiting Toxicities (DLTs) [ Time Frame: DLT period of 28 days ]

Locations (3)

FacilityCityStateZIPSite coordinators
Stanford Cancer CenterStanfordCalifornia94305-
University of Colorado HospitalAuroraColorado80045-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Related coverage on Hipa.ai

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By research site
Stanford Cancer Center· Stanford, CAUniversity of Colorado Hospital· Aurora, COUniversity of Texas MD Anderson Cancer Center· Houston, TX

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