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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

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
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown
Recruitment postcode(s) [1] 0 0
- Blacktown
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
Trial website
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
ClinicalTrials@Viracta.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05166577