Nanatinostat + Valganciclovir/Pembrolizumab for Nasopharyngeal Cancer

Recruiting in Toronto (>99 mi)

+21 other locations

Overseen By Afton Katkov, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Viracta Therapeutics, Inc.

Must not be taking: Cytotoxic drugs, Biologic therapy

Disqualifiers: Active CNS disease, Autoimmune, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

26 Participants Needed

Trial Summary

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.

Research Team

Darrel P Cohen, MD, PhD

Principal Investigator

Viracta Therapeutics

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Nanatinostat in combination with valganciclovir and pembrolizumab Experimental Treatment 3 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 valganciclovir Experimental Treatment 2 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

Who Is Running the Clinical Trial?

Viracta Therapeutics, Inc.

Lead Sponsor

Trials

4

Recruited

200+