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Nasopharyngeal CarcinomaPhase 1NCT05166577

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

A Phase 1 study testing Nanatinostat, Valganciclovir and Pembrolizumab in people with Nasopharyngeal Carcinoma and EBV-Related Gastric Carcinoma, run by Viracta Therapeutics, Inc. at 13 sites in 8 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nanatinostat, Valganciclovir and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
13 sitesin 8 countries
Study dates
8 Oct 2021to 10 Jan 2025
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

13 sites in 8 countries.

13 sites in 8 countries

United States3 sites

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Stanford Cancer Center

    Stanford, California, 94305

Other trials in United States

Hong Kong2 sites

  • Queen Mary Hospital

    Hong Kong

  • Prince Of Wales Hospital, The Chinese University Of Hong Kong

    Shatin

Other trials in Hong Kong

Malaysia2 sites

  • University of Malaya Medical Centre

    Kuala Lumpur

  • Sarawak General Hospital

    Kuching, Sarawak

Other trials in Malaysia

Taiwan2 sites

  • Taipei Veterans General Hospital

    Taipei

  • Linkou Chang Gung Memorial Hospital

    Taoyuan City

Other trials in Taiwan

Australia1 site

  • Blacktown Hospital

    Blacktown

Other trials in Australia

Canada1 site

  • Princess Margaret Cancer Centre

    Toronto

Other trials in Canada

Singapore1 site

  • National Cancer Centre Singapore

    Singapore

Other trials in Singapore

South Korea1 site

  • Samsung Medical Center

    Seoul

Other trials in South Korea

About this study

Official title: Open-Label Multicenter Phase 1b/2 Study of Nanatinostat + Valganciclovir in Patients With Advanced Epstein-Barr Virus-Positive Solid Tumors and in Combination With Pembrolizumab in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

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

Read the detailed 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.

The study was prematurely terminated after the end of Phase 1b and did not proceed to Phase 2.

Being tested
Nanatinostat, Valganciclovir, Pembrolizumab
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NanatinostatDrug

    Also called VRx-3996

    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

  • ValganciclovirDrug

    Also called Valcyte

    Phase 1b: Valganciclovir starting at 900 mg orally daily, then Phase 2: Valganciclovir at the confirmed recommended Phase 2 dose

  • PembrolizumabDrug

    Also called Keytruda

    Phase 2: Pembrolizumab (anti-PD-1) dosed at 200 mg intravenous (IV) every 3 weeks

Study groups in NCT05166577
Study groupRoleWhat they receive
Nanatinostat in combination with valganciclovirExperimentalPhase 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
Receives: Drug: Nanatinostat; Drug: Valganciclovir
Nanatinostat in combination with valganciclovir and pembrolizumabExperimentalPhase 2: Nanatinostat and valganciclovir at the confirmed recommended Phase 2 doses in combination with pembrolizumab 200 mg intravenous (IV) every 3 weeks
Receives: Drug: Nanatinostat; Drug: Valganciclovir; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1b: Incidence of Dose-Limiting Toxicities (DLTs)

    Percentage of patients experiencing a DLT, defined as an adverse event or clinically significant abnormal laboratory value that is at least possibly related to study drugs and is not primarily related to disease, disease progression, concomitant medication(s), or intercurrent illness

    Measured: DLT period of 28 days

  2. Phase 2: Overall Response Rate (ORR)

    Percentage of patients with a complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 (v1.1)

    Measured: Approximately 3 years

Secondary outcomes (13)

  1. Incidence of Adverse Events

    Percentage of patients experiencing at least one treatment-emergent adverse event (AE), defined as those AEs with onset after the first dose of study drug or existing events that worsened after the first dose during the study

    Measured: Approximately 3 years

  2. Phase 2: Duration of Response (DOR)

    Interval of time from the date of first observed CR or PR to the date of documented disease progression or death due to any cause, whichever occurs first

    Measured: Approximately 3 years

  3. Phase 2: Disease Control Rate (DCR)

    Percentage of patients having a CR, PR, or stable disease at any time during treatment

    Measured: Approximately 3 years

  4. Phase 2: Progression-Free Survival (PFS)

    Interval of time from the start of study drug treatment to the date of first documented disease progression or death from any cause, whichever occurs first

    Measured: Approximately 3 years

  5. Phase 2: Overall Survival (OS)

    Interval of time from the start of study drug treatment to date of death for any reason

    Measured: Approximately 3 years

  6. Pharmacokinetic Parameter (Nanatinostat) - Time to Maximum Plasma Concentration [Tmax]

    Defined as the time required to reach peak plasma concentration [Cmax] after nanatinostat administration on Cycle 2 Day 1

    Measured: Approximately 28 days following enrollment

  7. Pharmacokinetic Parameter (Ganciclovir) - Time to Maximum Plasma Concentration [Tmax]

    Defined as the time required to reach peak plasma concentration [Cmax] after valganciclovir administration on Cycle 2 Day 1

    Measured: Approximately 28 days following enrollment

  8. Pharmacokinetic Parameter (Nanatinostat) - Maximum Plasma Concentration [Cmax]

    Defined as the peak plasma concentration [Cmax] after nanatinostat administration on Cycle 2 Day 1

    Measured: Approximately 28 days following enrollment

  9. Pharmacokinetic Parameter (Ganciclovir) - Maximum Plasma Concentration [Cmax]

    Defined as the peak plasma concentration [Cmax] after valganciclovir administration on Cycle 2 Day 1

    Measured: Approximately 28 days following enrollment

  10. Pharmacokinetic Parameter (Nanatinostat) - Area Under the Plasma Concentration-Time Curve [AUC0-t]

    Defined as the area under the concentration-time curve from time 0 to the last measurable nanatinostat concentration on Cycle 2 Day 1

    Measured: Approximately 28 days following enrollment

  11. Pharmacokinetic Parameter (Ganciclovir) - Area Under the Plasma Concentration-Time Curve [AUC0-t]

    Defined as the area under the concentration-time curve from time 0 to the last measurable ganciclovir concentration on Cycle 2 Day 1

    Measured: Approximately 28 days following enrollment

  12. Pharmacokinetic Parameter (Nanatinostat) - Half-Life of Nanatinostat [t1/2]

    Defined as the time required to reduce nanatinostat plasma concentration by 50% after nanatinostat administration on Cycle 2 Day 1

    Measured: Approximately 28 days following enrollment

  13. Pharmacokinetic Parameter (Ganciclovir) - Half-Life of Ganciclovir [t1/2]

    Defined as the time required to reduce ganciclovir plasma concentration by 50% after valganciclovir administration on Cycle 2 Day 1

    Measured: Approximately 28 days following enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2021
  2. Study start8 Oct 2021
  3. Primary completion30 Oct 2024
  4. Study completion10 Jan 2025

Why it stopped: Sponsor Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A traditional 3+3 dose escalation design followed first by a dose optimization cohort and then by dose expansion with 1:1 randomization to receive nanatinostat and valganciclovir with or without pembrolizumab in Phase 2. The study was prematurely terminated after the end of Phase 1b and did not proceed to Phase 2.
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05166577
Sponsor's protocol ID
VT3996-301
Status last verified
Feb 2025
First submitted
3 Dec 2021
Last updated
12 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nanatinostat, Valganciclovir and Pembrolizumab in people with Nasopharyngeal Carcinoma and EBV-Related Gastric Carcinoma, run by Viracta Therapeutics, Inc. at 13 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Hong Kong, Malaysia, Taiwan, Australia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1b: Incidence of Dose-Limiting Toxicities (DLTs) (time frame: DLT period of 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05166577.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.

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