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HDAC inhibitor

Nanatinostat + Valganciclovir/Pembrolizumab for Nasopharyngeal Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Viracta Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Phase 1b exploratory proof-of-concept cohort only: Advanced/metastatic EBV+ non-NPC solid tumors with no available curative therapies

ECOG performance status 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 3 years

Awards & highlights

Study Summary

This trial will test if nanatinostat, in combination with valganciclovir or pembrolizumab, is safe and effective in treating patients with relapsed/refractory EBV-positive solid tumors or recurrent/metastatic nasopharyngeal carcinoma.

Who is the study for?

This trial is for adults with advanced EBV+ solid tumors, including nasopharyngeal carcinoma, who've tried at least one platinum-based chemotherapy but no more than three treatments. They must have measurable disease and be in good physical condition (ECOG 0 or 1), with proper bone marrow and liver function.Check my eligibility

What is being tested?

The study tests nanatinostat combined with valganciclovir for EBV+ solid tumors, and adds pembrolizumab for recurrent/metastatic nasopharyngeal carcinoma. It aims to assess the safety and effectiveness of these combinations.See study design

What are the potential side effects?

Potential side effects may include gastrointestinal issues due to oral medication absorption challenges, immune system reactions from autoimmune diseases being triggered or worsened, liver problems from hepatitis B/C infections, and complications related to CNS disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have an advanced cancer linked to EBV with no cure.

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I am fully active or can carry out light work.

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I have EBV+ nasopharyngeal cancer that has returned or spread, and I've had 1-3 treatments already.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1b: Incidence of dose-limiting toxicities (DLTs)

Phase 2: Overall response rate (ORR)

Secondary outcome measures

Disease control rate (DCR)

Duration of response (DOR)

Incidence and severity of adverse events

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Nanatinostat in combination with valganciclovir and pembrolizumabExperimental Treatment3 Interventions

Group II: Nanatinostat in combination with valganciclovirExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Valganciclovir

2019

Completed Phase 4

~2160

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Viracta Therapeutics, Inc.Lead Sponsor

3 Previous Clinical Trials

218 Total Patients Enrolled

Lisa Rojkjaer, MDStudy DirectorViracta Therapeutics

1 Previous Clinical Trials

140 Total Patients Enrolled

Darrel P Cohen, MD, PhDStudy DirectorViracta Therapeutics

1 Previous Clinical Trials

14 Total Patients Enrolled

Media Library

Nanatinostat (HDAC inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05166577 — Phase 1 & 2

Carcinoma Research Study Groups: Nanatinostat in combination with valganciclovir, Nanatinostat in combination with valganciclovir and pembrolizumab

Carcinoma Clinical Trial 2023: Nanatinostat Highlights & Side Effects. Trial Name: NCT05166577 — Phase 1 & 2

Nanatinostat (HDAC inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05166577 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What therapeutic purposes does Nanatinostat typically serve?

"Nanatinostat is primarily used to treat unresectable melanoma, however its clinical efficacy can also extend to addressing high risk of recurrence and microsatellite instability."

Answered by AI

Has recruitment for this study begun yet?

"As indicated by the listing on clinicaltrials.gov, this experiment is actively recruiting participants. The initial posting was made on October 7th 2021 and the information has been most recently refreshed as of November 22nd 2022."

Answered by AI

What is the maximum capacity of this clinical trial's participant pool?

"Viracta Therapeutics, Inc. is responsible for the recruitment of a hundred participants that meet this trial's criteria from two distinct locations: University of Colorado Hospital in Aurora and The Oncology Institute of Hope and Innovation in Torrance, California."

Answered by AI

How many locations have enrolled in the experiment?

"The research project is being conducted in 6 distinct locations, with 3 centres situated in Aurora, Torrance and Lynwood. Other cities are also available to choose from so that the distance between the trial site and you can be minimized."

Answered by AI

Has there been previous research focused on Nanatinostat?

"Since 2004, Nanatinostat has been studied extensively with 293 completed clinical studies. Currently, 973 active trials are being conducted and many of them take place in Aurora, Colorado."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Nanatinostat Plus Valganciclovir in Patients With Advanced EBV+ Solid Tumors, and in Combination With Pembrolizumab in EBV+ RM-NPC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05166577.

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