Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV+ Lymphoid Malignancies
Purpose
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
- Epstein-Barr Virus-Associated Lymphoma
- Lymphoproliferative Disorders
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- Phase 1: dose escalation phase (3+3 design with definitions of dose limiting toxicity) to define a recommended phase 2 dose Phase 2: dose expansion Tablet PK Cohort
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Phase 1b Dose Escalation |
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 |
|
|
Experimental Phase 2 Expansion - Capsule |
VRx-3996 and valganciclovir at the recommended Phase 2 dose (RP2D) |
|
|
Experimental Phase 2 Expansion - Tablet |
VRx-3996 and valganciclovir at the recommended Phase 2 dose (RP2D) |
|
More Details
- Status
- Completed
- Sponsor
- Viracta Therapeutics, Inc.
Study Contact
Detailed Description
The purpose of this study is to determine whether VRx-3996 in combination with valganciclovir is safe, determine the side effect profile, and to determine whether this therapy may help patients with EBV-related lymphomas. The study has two phases. Goals of the first phase include determining a safe and tolerable dose that can be administered in phase 2. Goals of the second phase include further evaluating the safety and tolerability of VRx-3996 in combination with valganciclovir, evaluating how the drugs are metabolized in the body, evaluating response rates and other exploratory objectives that will help the researchers evaluate how these drugs work in the body. Participants will receive daily oral doses of the two study drugs and will have multiple study visits where they will have blood collected, physical examinations, and other medical monitoring. Following completion of the Ph2, the study will enroll additional patients into a Tablet Pharmacokinetic (PK) cohort to investigate the PK parameters of the tablet formulation.