Neoplasms

Blood and Lymph Conditions

Immune System Diseases

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Infections

Symptoms and General Pathology

Rare Diseases

Lymphoma

Immunologic Deficiency Syndromes

Epstein-Barr Virus Infections

Lymphoproliferative Disorders

Virus Diseases

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Immunoproliferative Disorders

Herpesviridae Infections

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Anti-Infective Agents

All Drugs and Chemicals

Valganciclovir

Antiviral Agents

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

VRx-3996 (RP2D: recommended phase 2 dose) and valganciclovir

Assessment of VRx-3996 tablet and valganciclovir PK parameters at the RP2D

VRx-3996

Jill DeFratis Robinson

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.

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 PK cohort to investigate the PK parameters of the tablet formulation.

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

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

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

Determination of a safe and tolerable Recommended Phase 2 Dose (RP2D)

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

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

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

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

The interval between the date of first study drug administration and the date of PD or death, whichever is first reported

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV-Associated Lymphoid Malignancies	NCT03397706	Epstein-Barr Vi... Lymphoprolifera...	VRx-3996 Valganciclovir	18 Years -	Viracta Therapeutics, Inc.
Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV-Associated Lymphoid Malignancies	NCT03397706	Epstein-Barr Vi... Lymphoprolifera...	VRx-3996 Valganciclovir	18 Years -	Viracta Therapeutics, Inc.

Spots Global Cancer Trial Database for relapsed, refractory, ebv+ lymphoid malignancy