Nanatinostat Plus Valganciclovir in Advanced EBV+ Solid Tumors and in Combination With Pembrolizumab in EBV+ RM-NPC
NCT ID: NCT05166577
Last Updated: 2025-03-12
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
26 participants
INTERVENTIONAL
2021-10-08
2025-01-10
Brief Summary
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Detailed Description
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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 followed by a Project Optimus \| FDA (https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus) cohort to confirm the RP2D. Up to 60 patients with EBV+ RM-NPC will be randomized 1:1 to receive nanatinostat in combination with valganciclovir at the confirmed RP2D with or without pembrolizumab to evaluate safety, overall response rate, and potential pharmacodynamic markers in the Phase 2 dose expansion part of the study. Additionally, patients with other EBV+ solid tumors will be enrolled to receive nanatinostat in combination with valganciclovir at the RP2D in a Phase 1b cohort.
The study was prematurely terminated after the end of Phase 1b and did not proceed to Phase 2.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
The study was prematurely terminated after the end of Phase 1b and did not proceed to Phase 2.
TREATMENT
NONE
Study Groups
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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
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
Valganciclovir
Phase 1b: Valganciclovir starting at 900 mg orally daily, then Phase 2: Valganciclovir at the confirmed recommended Phase 2 dose
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
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
Valganciclovir
Phase 1b: Valganciclovir starting at 900 mg orally daily, then Phase 2: Valganciclovir at the confirmed recommended Phase 2 dose
Pembrolizumab
Phase 2: Pembrolizumab (anti-PD-1) dosed at 200 mg intravenous (IV) every 3 weeks
Interventions
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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
Valganciclovir
Phase 1b: Valganciclovir starting at 900 mg orally daily, then Phase 2: Valganciclovir at the confirmed recommended Phase 2 dose
Pembrolizumab
Phase 2: Pembrolizumab (anti-PD-1) dosed at 200 mg intravenous (IV) every 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Viracta Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Darrel P Cohen, MD, PhD
Role: STUDY_DIRECTOR
Viracta Therapeutics
Locations
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Stanford Cancer Center
Stanford, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Blacktown Hospital
Blacktown, , Australia
Princess Margaret Cancer Centre
Toronto, , Canada
Queen Mary Hospital
Hong Kong, , Hong Kong
Prince Of Wales Hospital, The Chinese University Of Hong Kong
Shatin, , Hong Kong
Sarawak General Hospital
Kuching, Sarawak, Malaysia
University of Malaya Medical Centre
Kuala Lumpur, , Malaysia
National Cancer Centre Singapore
Singapore, , Singapore
Samsung Medical Center
Seoul, , South Korea
Taipei Veterans General Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, , Taiwan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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VT3996-301
Identifier Type: -
Identifier Source: org_study_id
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