Clinical trial · Interventional
Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV+ Lymphoid Malignancies
A Phase 1b/2 Open-Label, Dose Escalation & Expansion Study of Orally Administered Viracta (VRx)-3996 & Valganciclovir in Subjects With Epstein-Barr Virus-Associated Lymphoid Malignancies
NCT03397706CI-TRIAL-00087427completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 Epstein-Barr Virus Associated Lymphoma (EBV+ lymphomas).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epstein-Barr Virus-Associated Lymphoma | — | UNRESOLVED | — |
| Lymphoproliferative Disorders | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VRx-3996 and valganciclovir | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Phase 1b Dose Escalation
- description
- VRx-3996 (cohort 1) and valganciclovir VRx-3996 (cohort 2) and valganciclovir VRx-3996 (cohort 3) and valganciclovir VRx-3996 (cohort 4) and valganciclovir VRx-3996 (cohort 5) and valganciclovir
- interventionNames
- Combination Product: VRx-3996 and valganciclovir
- type
- EXPERIMENTAL
- label
- Phase 2 Expansion - Capsule
- description
- VRx-3996 and valganciclovir at the recommended Phase 2 dose (RP2D)
- interventionNames
- Combination Product: VRx-3996 and valganciclovir
- type
- EXPERIMENTAL
- label
- Phase 2 Expansion - Tablet
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Relapsed/refractory, pathologically confirmed Epstein-Barr Virus positive (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 central nervous system (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 quantitative polymerase chain reaction (qPCR) * Known history of human herpes virus (HHV)-6 chromosomal integration * Known history of HIV infection
References
Publications (1)
- DERIVEDHaverkos B, Alpdogan O, Baiocchi R, Brammer JE, Feldman TA, Capra M, Brem EA, Nair S, Scheinberg P, Pereira J, Shune L, Joffe E, Young P, Spruill S, Katkov A, McRae R, Royston I, Faller DV, Rojkjaer L, Porcu P. Targeted therapy with nanatinostat and valganciclovir in recurrent EBV-positive lymphoid malignancies: a phase 1b/2 study. Blood Adv. 2023 Oct 24;7(20):6339-6350. doi: 10.1182/bloodadvances.2023010330. PMID 37530631