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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05166577




Registration number
NCT05166577
Ethics application status
Date submitted
3/12/2021
Date registered
22/12/2021
Date last updated
15/10/2024

Titles & IDs
Public title
Nanatinostat Plus Valganciclovir in Patients with Advanced EBV+ Solid Tumors, and in Combination with Pembrolizumab in EBV+ RM-NPC
Scientific title
An Open-Label, Multicenter Phase 1b/2 Study of Nanatinostat and Valganciclovir in Patients with Advanced Epstein-Barr Virus-Positive (EBV+) Solid Tumors and in Combination with Pembrolizumab in Patients with Recurrent/Metastatic Nasopharyngeal Carcinoma
Secondary ID [1] 0 0
VT3996-301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nasopharyngeal Carcinoma 0 0
EBV-Related Gastric Carcinoma 0 0
EBV-Related Leiomyosarcoma 0 0
EBV Related Carcinoma 0 0
EBV-Related Sarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nanatinostat
Treatment: Drugs - Nanatinostat
Treatment: Drugs - Valganciclovir
Treatment: Drugs - Pembrolizumab

Experimental: Nanatinostat in combination with valganciclovir -

Experimental: Nanatinostat in combination with valganciclovir and pembrolizumab -


Treatment: Drugs: Nanatinostat
Nanatinostat dose escalation starting at 20 mg orally daily, 4 days per week

Treatment: Drugs: Nanatinostat
Nanatinostat at the confirmed RP2D

Treatment: Drugs: Valganciclovir
Valganciclovir starting at 900 mg orally daily

Treatment: Drugs: Pembrolizumab
Pembrolizumab (anti-PD-1) dosed at 200 mg intravenous (IV) every 3 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1b: Incidence of dose-limiting toxicities (DLTs)
Timepoint [1] 0 0
DLT period of 28 Days
Primary outcome [2] 0 0
Phase 2: Overall response rate (ORR)
Timepoint [2] 0 0
Approximately 3 years
Secondary outcome [1] 0 0
Incidence and severity of adverse events
Timepoint [1] 0 0
Approximately 28 days following the last dose
Secondary outcome [2] 0 0
Duration of response (DOR)
Timepoint [2] 0 0
Approximately 3 years
Secondary outcome [3] 0 0
Disease control rate (DCR)
Timepoint [3] 0 0
Approximately 3 years
Secondary outcome [4] 0 0
Progression-free survival (PFS)
Timepoint [4] 0 0
Approximately 3 years
Secondary outcome [5] 0 0
Overall survival (OS)
Timepoint [5] 0 0
Approximately 3 years
Secondary outcome [6] 0 0
Pharmacokinetic parameter - time to maximum plasma concentration [tmax]
Timepoint [6] 0 0
Approximately at 28 days following enrollment
Secondary outcome [7] 0 0
Pharmacokinetic parameter - maximum plasma concentration [Cmax]
Timepoint [7] 0 0
Approximately 28 days following enrollment
Secondary outcome [8] 0 0
Pharmacokinetic parameter - area under the plasma concentration-time curve [AUC]
Timepoint [8] 0 0
Approximately 28 days following enrollment

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 0 0
Macquarie University - Sydney
Recruitment postcode(s) [1] 0 0
- Blacktown
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Canada
State/province [4] 0 0
Toronto
Country [5] 0 0
Hong Kong
State/province [5] 0 0
Hong Kong
Country [6] 0 0
Hong Kong
State/province [6] 0 0
Sha Tin
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Seoul
Country [8] 0 0
Malaysia
State/province [8] 0 0
Sarawak
Country [9] 0 0
Malaysia
State/province [9] 0 0
Kuala Lumpur
Country [10] 0 0
Singapore
State/province [10] 0 0
Singapore
Country [11] 0 0
Taiwan
State/province [11] 0 0
Taipei City
Country [12] 0 0
Taiwan
State/province [12] 0 0
Taoyuan City

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Viracta Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/study/NCT05166577
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Darrel P Cohen, MD, PhD
Address 0 0
Viracta Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Afton Katkov, MSc
Address 0 0
Country 0 0
Phone 0 0
858-400-8470
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05166577