Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03397706 · OUTCOME

Overall Response Rate

Dose Escalation & Expansion Study of Oral VRx-3996 & Valganciclovir in Subjects With EBV+ Lymphoid Malignancies · Source last updated 2025-03-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to approximately 2 years

What was measured

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)

Analysis population: Efficacy Evaluable Analysis Set, defined as all patients with measurable/evaluable disease at screening who met all eligibility criteria and had at least one evaluable post-baseline efficacy tumor assessment. Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.

Groups in this outcome

Phase 1b Dose Escalation Cohort 1

VRx-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID

Phase 1b Dose Escalation Cohort 2a

VRx-3996: 5 mg BID valganciclovir: 450 mg BID

Phase 1b Dose Escalation Cohort 2b

VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID

Phase 1b Dose Escalation Cohort 2c

VRx-3996: 10 mg QD valganciclovir: 900 mg QD

Phase 1b Dose Escalation Cohort 3

VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD

Phase 2 Dose Expansion - Capsule

VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)

Phase 2 Dose Expansion - Tablet

VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase 1b Dose Escalation Cohort 16
Phase 1b Dose Escalation Cohort 2a2
Phase 1b Dose Escalation Cohort 2b2
Phase 1b Dose Escalation Cohort 2c4
Phase 1b Dose Escalation Cohort 35
Phase 2 Dose Expansion - Capsule23
Phase 2 Dose Expansion - Tablet8

Reported measurements

Source class 1

Complete Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1b Dose Escalation Cohort 12Not reportedNot reportedNot reportedNot reported
Phase 1b Dose Escalation Cohort 2a1Not reportedNot reportedNot reportedNot reported
Phase 1b Dose Escalation Cohort 2b0Not reportedNot reportedNot reportedNot reported
Phase 1b Dose Escalation Cohort 2c0Not reportedNot reportedNot reportedNot reported
Phase 1b Dose Escalation Cohort 31Not reportedNot reportedNot reportedNot reported
Phase 2 Dose Expansion - Capsule3Not reportedNot reportedNot reportedNot reported
Phase 2 Dose Expansion - Tablet1Not reportedNot reportedNot reportedNot reported

Partial Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1b Dose Escalation Cohort 11Not reportedNot reportedNot reportedNot reported
Phase 1b Dose Escalation Cohort 2a1Not reportedNot reportedNot reportedNot reported
Phase 1b Dose Escalation Cohort 2b1Not reportedNot reportedNot reportedNot reported
Phase 1b Dose Escalation Cohort 2c0Not reportedNot reportedNot reportedNot reported
Phase 1b Dose Escalation Cohort 32Not reportedNot reportedNot reportedNot reported
Phase 2 Dose Expansion - Capsule4Not reportedNot reportedNot reportedNot reported
Phase 2 Dose Expansion - Tablet1Not reportedNot reportedNot reportedNot reported

Stable Disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1b Dose Escalation Cohort 11Not reportedNot reportedNot reportedNot reported
Phase 1b Dose Escalation Cohort 2a0Not reportedNot reportedNot reportedNot reported
Phase 1b Dose Escalation Cohort 2b0Not reportedNot reportedNot reportedNot reported
Phase 1b Dose Escalation Cohort 2c1Not reportedNot reportedNot reportedNot reported
Phase 1b Dose Escalation Cohort 31Not reportedNot reportedNot reportedNot reported
Phase 2 Dose Expansion - Capsule5Not reportedNot reportedNot reportedNot reported
Phase 2 Dose Expansion - Tablet1Not reportedNot reportedNot reportedNot reported

Progressive Disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1b Dose Escalation Cohort 12Not reportedNot reportedNot reportedNot reported
Phase 1b Dose Escalation Cohort 2a0Not reportedNot reportedNot reportedNot reported
Phase 1b Dose Escalation Cohort 2b1Not reportedNot reportedNot reportedNot reported
Phase 1b Dose Escalation Cohort 2c3Not reportedNot reportedNot reportedNot reported
Phase 1b Dose Escalation Cohort 31Not reportedNot reportedNot reportedNot reported
Phase 2 Dose Expansion - Capsule11Not reportedNot reportedNot reportedNot reported
Phase 2 Dose Expansion - Tablet5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        3
      7. group Id
        OG006
        value
        1
      title
      Complete Response
    2. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        4
      7. group Id
        OG006
        value
        1
      title
      Partial Response
    3. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        5
      7. group Id
        OG006
        value
        1
      title
      Stable Disease
    4. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        11
      7. group Id
        OG006
        value
        5
      title
      Progressive Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      2
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      5
    6. group Id
      OG005
      value
      23
    7. group Id
      OG006
      value
      8
    units
    Participants
description
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)
groups
  1. description
    VRx-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID
    id
    OG000
    title
    Phase 1b Dose Escalation Cohort 1
  2. description
    VRx-3996: 5 mg BID valganciclovir: 450 mg BID
    id
    OG001
    title
    Phase 1b Dose Escalation Cohort 2a
  3. description
    VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID
    id
    OG002
    title
    Phase 1b Dose Escalation Cohort 2b
  4. description
    VRx-3996: 10 mg QD valganciclovir: 900 mg QD
    id
    OG003
    title
    Phase 1b Dose Escalation Cohort 2c
  5. description
    VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD
    id
    OG004
    title
    Phase 1b Dose Escalation Cohort 3
  6. description
    VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)
    id
    OG005
    title
    Phase 2 Dose Expansion - Capsule
  7. description
    VRx-3996 (RP2D: 20 mg QD on Days 1 to 4/week) and valganciclovir (RP2D: 900 mg QD)
    id
    OG006
    title
    Phase 2 Dose Expansion - Tablet
param Type
COUNT_OF_PARTICIPANTS
population Description
Efficacy Evaluable Analysis Set, defined as all patients with measurable/evaluable disease at screening who met all eligibility criteria and had at least one evaluable post-baseline efficacy tumor assessment. Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.
reporting Status
POSTED
time Frame
Up to approximately 2 years
title
Overall Response Rate
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice