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VRx-3996 and valganciclovir

Phase 1

Epstein-Barr Virus-Associated Lymphoma | Small molecule | Oncology |Viracta Therapeutics, Inc.|Last Updated: Mar 20, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment64
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03397706Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV+ Lymphoid MalignanciesPHASE1 COMPLETED 64Mar 29, 2018May 4, 2023Mar 20, 202528 United States, Brazil
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Study Endpoints
Primary Endpoints
Number (Proportion) of Participants With Adverse Events (AEs)
Up to approximately 2 years

Number (percentage) of patients experiencing at least one treatment-emergent adverse event, defined as those untoward medical events with onset after the first dose of study drug or existing events that worsened after the first dose during the study

Number (Proportion) of Participants With Dose-Limiting Toxicities (DLTs) in Phase 1b
Cycle 1 (28 days)

Number (percentage) of patients experiencing a DLT during the first cycle (28 days) of study treatment in Phase 1b, defined as an adverse event (AE) or clinically significant abnormal laboratory value that was at least possibly related to study drugs and was not primarily related to disease, disease progression, concomitant medication(s), or intercurrent illness. In addition, to be considered a DLT, the AE had to meet at least one of the following criteria: * Grade 4 anemia unexplained by underlying disease * Grade 4 febrile neutropenia * Grade 4 neutropenia lasting \>5 days * Any other Grade 4 hematologic toxicity (thrombocytopenia, neutropenia, febrile neutropenia, anemia) of any duration * Grade 4 or higher tumor lysis syndrome * Grade 3 or higher thrombocytopenia (with or without bleeding) * Any requirement for platelet transfusion * Grade 3 or higher non-hematologic toxicity despite adequate supportive care * Results in a dose hold of \>7 consecutive days

Overall Response Rate
Up to approximately 2 years

Number (percentage) of patients with a best overall complete response (CR) or partial response (PR) according to the Lugano 2014 criteria (Cheson, Bruce D. et al. J Clin Oncology 2014;32(27):3059-68), where CR included complete metabolic response (no/minimal fluorodeoxyglucose \[FDG\] uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions, and PR included partial metabolic response (reduced FDG uptake compared with baseline) or radiologic response (target lesions ≤ 50% decrease in the sum of the product of perpendicular diameters of up to 6 target measurable nodes and extranodal sites)

Secondary Endpoints
Duration of Response
Up to approximately 2 years
Time to Response
Up to approximately 2 years
Progression-Free Survival
Up to approximately 2 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1b Dose EscalationEXPERIMENTALVRx-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
Phase 2 Expansion - CapsuleEXPERIMENTALVRx-3996 and valganciclovir at the recommended Phase 2 dose (RP2D)
Phase 2 Expansion - TabletEXPERIMENTALVRx-3996 and valganciclovir at the recommended Phase 2 dose (RP2D)
Interventions
NameTypeDescription
VRx-3996 and valganciclovirCOMBINATION_PRODUCTsecond-generation histone deacetylase (HDAC) inhibitor, nanatinostat (previously referred to as either VRx-3996 or CHR-3396)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites28

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 f...

Countries:United StatesBrazil
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