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Clinical trial

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

ID
Name
VT3996-201
Description
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.
Trial arms
Trial start
2018-03-29
Estimated PCD
2023-04-01
Trial end
2023-05-04
Status
Completed
Phase
Early phase I
Treatment
VRx-3996
Taken orally once or twice daily
Arms:
PK Cohort, Phase 1b Dose Escalation, Phase 2 Dose Expansion
Other names:
Nanatinostat
Valganciclovir
Taken orally once or twice daily
Arms:
PK Cohort, Phase 1b Dose Escalation, Phase 2 Dose Expansion
Size
64
Primary endpoint
Incidence of adverse events and changes in clinical safety laboratory values in Dose Escalation and Cohort Expansion
Up to approximately 2 years
Incidence of Dose Limiting Toxicities in Dose Escalation and Cohort Expansion
Up to approximately 2 years
ORR as measured by stable disease (SD), partial response (PR), and complete response (CR) by radiographic assessment
Up to approximately 2 years
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Phase 1: dose escalation phase (3+3 design with definitions of dose limiting toxicity) to define a recommended phase 2 dose\n\nPhase 2: dose expansion\n\nPK Cohort', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 64, 'type': 'ACTUAL'}}
Updated at
2024-03-05

1 organization

2 products

2 indications

Organization
Viracta Therapeutics
Product
VRx-3996
Indication
Epstein-Barr Virus Associated Lymphoma
Indication
Lymphoproliferative Disorders
Product
Valganciclovir