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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05166577
Other study ID # VT3996-301
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date October 8, 2021
Est. completion date October 2025

Study information

Verified date March 2024
Source Viracta Therapeutics, Inc.
Contact Afton Katkov, MSc
Phone 858-400-8470
Email ClinicalTrials@Viracta.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 130
Est. completion date October 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Nanatinostat
Nanatinostat dose escalation starting at 20 mg orally daily, 4 days per week
Nanatinostat
Nanatinostat at the confirmed RP2D
Valganciclovir
Valganciclovir starting at 900 mg orally daily
Pembrolizumab
Pembrolizumab (anti-PD-1) dosed at 200 mg intravenous (IV) every 3 weeks

Locations

Country Name City State
Australia Blacktown Hospital Blacktown
Australia Macquarie University Sydney
Canada Princess Margaret Cancer Centre Toronto
Hong Kong Queen Mary Hospital Hong Kong
Hong Kong Hong Kong United Oncology Centre Kowloon
Hong Kong Prince Of Wales Hospital, The Chinese University Of Hong Kong Sha Tin
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of The Catholic University of Korea, Seoul St. Mary's Hospital Seoul
Malaysia University of Malaya Medical Centre Kuala Lumpur
Malaysia Sarawak General Hospital Kuching Sarawak
Malaysia National Cancer Institute (Institut Kanser Negara) Putrajaya
Singapore National Cancer Centre Singapore Singapore
Singapore Tan Tock Seng Hospital Singapore
Taiwan Mackay Memorial Hospital Taipei
Taiwan National Taiwan University Hospital Taipei City
Taiwan Taipei Veterans General Hospital Taipei City
Taiwan Linkou Chang Gung Memorial Hospital Taoyuan City
United States University of Colorado Hospital Aurora Colorado
United States University of Texas MD Anderson Cancer Center Houston Texas
United States The Oncology Institute of Hope and Innovation Lynwood California
United States Stanford Cancer Center Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Viracta Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Hong Kong,  Korea, Republic of,  Malaysia,  Singapore,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phase 1b: Incidence of dose-limiting toxicities (DLTs) DLT period of 28 Days
Primary Phase 2: Overall response rate (ORR) Approximately 3 years
Secondary Incidence and severity of adverse events Approximately 28 days following the last dose
Secondary Duration of response (DOR) Approximately 3 years
Secondary Disease control rate (DCR) Approximately 3 years
Secondary Progression-free survival (PFS) Approximately 3 years
Secondary Overall survival (OS) Approximately 3 years
Secondary Pharmacokinetic parameter - time to maximum plasma concentration [tmax] Approximately at 28 days following enrollment
Secondary Pharmacokinetic parameter - maximum plasma concentration [Cmax] Approximately 28 days following enrollment
Secondary Pharmacokinetic parameter - area under the plasma concentration-time curve [AUC] Approximately 28 days following enrollment
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