Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV-Associated Lymphoid Malignancies

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A two part, Phase 1b/2 study to define a recommended Phase 2 dose of VRx-3996 in combination with valganciclovir (Phase 1b) designed to evaluate the efficacy of this combination in relapsed/refractory EBV+ lymphomas.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Viracta Therapeutics, Inc.
• Treatments: Ganciclovir; Valganciclovir

Criteria

Key Inclusion Criteria:

• Relapsed/refractory, pathologically confirmed EBV+ lymphoid malignancy or lymphoproliferative disease

• Absence of available therapy with reasonable likelihood of cure or significant clinical benefit

• Adequate hematologic, hepatic and renal function as defined by laboratory assessment

Key Exclusion Criteria:

• Known primary CNS lymphoma

• Known CNS metastases or leptomeningeal disease unless appropriately treated and neurologically stable for at least 4 weeks

• Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy

• Refractory graft versus host disease (GvHD) not responding to treatment

• Known active hepatitis B virus infection

• Circulating hepatitis C virus on qPCR

• Known history of HHV-6 chromosomal integration

• Known history of HIV infection