26 Participants Needed

Nanatinostat + Valganciclovir/Pembrolizumab for Nasopharyngeal Cancer

Recruiting at 21 trial locations
AK
Overseen ByAfton Katkov, MSc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of nanatinostat, valganciclovir, and pembrolizumab in patients with certain EBV-related cancers. Nanatinostat makes cancer cells more vulnerable, allowing valganciclovir to kill them, while pembrolizumab boosts the immune system to fight the cancer.

Who Is on the Research Team?

DP

Darrel P Cohen, MD, PhD

Principal Investigator

Viracta Therapeutics

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Measurable disease per RECIST v1.1
I have an advanced cancer linked to EBV with no cure.
I am fully active or can carry out light work.
See 2 more

Exclusion Criteria

I cannot take pills or have a condition that affects how my body absorbs medication.
I have an autoimmune disease treated with strong medication.
I have an active brain or spinal cord disease.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1b Dose Escalation

Nanatinostat dose escalation starting at 20 mg orally daily, 4 days per week, and valganciclovir starting at 900 mg orally daily to evaluate safety and determine the recommended Phase 2 dose

4 weeks
Weekly visits for dose escalation monitoring

Phase 1b Cohort

Patients with other EBV+ solid tumors receive nanatinostat in combination with valganciclovir at the RP2D

Approximately 28 days
Visits every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Nanatinostat
  • Pembrolizumab
  • Valganciclovir
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Nanatinostat in combination with valganciclovir and pembrolizumabExperimental Treatment3 Interventions
Phase 2: Nanatinostat and valganciclovir at the confirmed recommended Phase 2 doses in combination with pembrolizumab 200 mg intravenous (IV) every 3 weeks
Group II: Nanatinostat in combination with valganciclovirExperimental Treatment2 Interventions
Phase 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Viracta Therapeutics, Inc.

Lead Sponsor

Trials
4
Recruited
200+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security