Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV-Associated Lymphoid Malignancies
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ClinicalTrials.gov Identifier: NCT03397706 |
Recruitment Status :
Recruiting
First Posted : January 12, 2018
Last Update Posted : July 28, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Epstein-Barr Virus Associated Lymphoma Lymphoproliferative Disorders | Drug: VRx-3996 Drug: Valganciclovir | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 65 participants |
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 PK Cohort |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1b/2 Open-Label, Dose Escalation & Expansion Study of Orally Administered VRx-3996 & Valganciclovir in Subjects With Epstein-Barr Virus-Associated Lymphoid Malignancies |
Actual Study Start Date : | March 29, 2018 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | December 2022 |

Arm | Intervention/treatment |
---|---|
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 |
Drug: VRx-3996
Taken orally once or twice daily
Other Name: Nanatinostat Drug: Valganciclovir Taken orally once or twice daily |
Experimental: Phase 2 Dose Expansion
VRx-3996 (RP2D: recommended phase 2 dose) and valganciclovir
|
Drug: VRx-3996
Taken orally once or twice daily
Other Name: Nanatinostat Drug: Valganciclovir Taken orally once or twice daily |
Experimental: PK Cohort
Assessment of VRx-3996 tablet and valganciclovir PK parameters at the RP2D
|
Drug: VRx-3996
Taken orally once or twice daily
Other Name: Nanatinostat Drug: Valganciclovir Taken orally once or twice daily |
- Incidence of adverse events and changes in clinical safety laboratory values in Dose Escalation and Cohort Expansion [ Time Frame: Up to approximately 2 years ]Determination of a safe and tolerable Recommended Phase 2 Dose (RP2D)
- Incidence of Dose Limiting Toxicities in Dose Escalation and Cohort Expansion [ Time Frame: Up to approximately 2 years ]
- ORR as measured by stable disease (SD), partial response (PR), and complete response (CR) by radiographic assessment [ Time Frame: Up to approximately 2 years ]
- Single-dose and steady-state Cmax of VRx-3996 and valganciclovir [ Time Frame: Through Cycle 2 Day 15 (each cycle is 28 days) ]PK assessment of both VRx-3996 and valganciclovir pre-dose and at hours 0.5, 1, 2, 4, and 6 post-dose on C1 and C2D1 and pre-dose and at hour 2 on C1D2 ,C1D15, and C2D15
- Single-dose and steady-state AUC of VRx-3996 and valganciclovir [ Time Frame: Through Cycle 2 Day 15 (each cycle is 28 days) ]PK assessment of both VRx-3996 and valganciclovir pre-dose and at hours 0.5, 1, 2, 4, and 6 post-dose on C1 and C2D1 and pre-dose and at hour 2 on C1D2 ,C1D15, and C2D15
- Steady-state elimination half-life of VRx-3996 and valganciclovir [ Time Frame: Through Cycle 2 Day 15 (each cycle is 28 days) ]PK assessment of both VRx-3996 and valganciclovir pre-dose and at hours 0.5, 1, 2, 4, and 6 post-dose on C1 and C2D1 and pre-dose and at hour 2 on C1D2, C1D15, and C2D15
- Time to response [ Time Frame: Approximately 6 months ]The time from the start of first study drug administration to the first overall tumor response observed for subjects who achieved a CR or PR
- Duration of response [ Time Frame: Up to approximately 2 years ]The time interval (days) from date of the first overall response (CR or PR; achieved after study drug administration) to the date of disease progression
- Progression-free survival [ Time Frame: Up to approximately 2 years ]The interval between the date of first study drug administration and the date of PD or death, whichever is first reported

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397706
Contact: Robert McRae, Vice President, Operations | 858-400-8470 | ClinicalTrials@Viracta.com |

Study Director: | Robert McRae | Viracta Therapeutics |
Responsible Party: | Viracta Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT03397706 |
Other Study ID Numbers: |
VT3996-201 |
First Posted: | January 12, 2018 Key Record Dates |
Last Update Posted: | July 28, 2021 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
EBV+ post-transplant lymphoproliferative malignancy EBV-associated lymphoproliferative disorders associated with acquired immunodeficiency Relapsed, refractory, EBV+ lymphoid malignancy |
Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Valganciclovir Antiviral Agents Anti-Infective Agents |