Phase 2
N=64
Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV+ Lymphoid Malignancies
Epstein-Barr Virus-Associated Lymphoma · Lymphoproliferative Disorders
Bottom Line
View on ClinicalTrials.gov: NCT03397706 ↗Enrolled (actual)
64
Serious AEs
35.9%
Results posted
Mar 2025
Primary outcome: Primary: Number (Proportion) of Participants With Adverse Events (AEs) — 7; 5; 4; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VRx-3996 and valganciclovir (Combination_product)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Viracta Therapeutics, Inc.
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number (Proportion) of Participants With Adverse Events (AEs) |
7; 5; 4; 4; 5; 30 | — |
| PRIMARY Number (Proportion) of Participants With Dose-Limiting Toxicities (DLTs) in Phase 1b |
4; 0; 0; 0; 0 | — |
| PRIMARY Overall Response Rate |
2; 1; 0; 0; 1; 3 | — |
| SECONDARY Duration of Response |
825.5; 116.5; 113.0; NA; 634.0; NA | — |
| SECONDARY Time to Response |
NA; 52.5; NA; NA; 162.0; NA | — |
| SECONDARY Progression-Free Survival |
209.0; 168.0; 107.5; 55.5; 185.0; 66.0 | — |
| SECONDARY Disease Control Rate |
4; 2; 1; 1; 4; 12 | — |
| SECONDARY Overall Survival |
227.0; 578.0; NA; 168.5; 496.0; 801.0 | — |
| SECONDARY Cmax (ng/mL) of VRx-3996 |
29.8; 83.3; 214; 196; 298; 334 | — |
| SECONDARY Cmax (ng/mL) of Valganciclovir |
4230; 6712; 7300; 14900; 8690; 14200 | — |
| SECONDARY Area Under Curve (AUC) 0-t of VRx-3996 |
128; 229; 340; 417; 587; 638 | — |
| SECONDARY AUC 0-t of of Valganciclovir |
15600; 24400; 25200; 49700; 28300; 46600 | — |
| SECONDARY Half-life of VRx-3996 |
1.89; 1.44; 1.46; 1.43; 1.10; 1.87 | — |
| SECONDARY Half-life of Valganciclovir |
3.56; 3.13; 3.32; 2.17; 2.43; 2.61 | — |
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 Epstein-Barr Virus Associated Lymphoma (EBV+ lymphomas).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03397706). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.