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NCT04442126 · OUTCOME

Assessment of the Volume of Distribution (Vd)

A Study of NM21-1480 in Adult Patients With Advanced Solid Tumors · Source last updated 2025-05-23

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

Measure
MEAN
Unit
L
Interval / dispersion
Standard Deviation
Time frame
From baseline to up to 12 weeks post last dose, up to 48 weeks.

Analysis population: Assessment of the volume of distribution (Vd) determined at C1 for all dose levels with the exception of Part A Dose Level 1,2 and 3. Lower limit of quantification (LLOQ) of NM21-1480 = 5 ng/mL.

Groups in this outcome

Part A Dose Level 1 NM21-1480-Q2W 0.15mg

Flat dose level; 0.15mg (Dose Level 1)

Part A Dose Level 2 NM21-1480-Q2W 1.5mg

Flat dose level; 1.5mg (Dose Level 2)

Part A Dose Level 3 NM21-1480-Q2W 8mg

Flat dose level; 8mg (Dose Level 3)

Part A Dose Level 4 NM21-1480-Q2W 24mg

Flat dose level; 24mg (Dose Level 4)

Part A Dose Level 5 NM21-1480-Q2W 80mg

Flat dose level; 80mg (Dose Level 5)

Part A Dose Level 6 NM21-1480-Q2W 240mg

Flat dose level; 240mg (Dose Level 6)

Part A Dose Level 7 NM21-1480-Q2W 800mg

Flat dose level; mg800 (Dose Level 7)

Part A2 NM21-1480-Q2W

This part of the study consisted of a 1400mg flat dose across one cohort.

Part B NM21-1480-Q2W

This part of the study consisted of a 800mg flat dose across three cohorts.

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

Analysis denominator · Participants

GroupSource count
Part A Dose Level 1 NM21-1480-Q2W 0.15mg0
Part A Dose Level 2 NM21-1480-Q2W 1.5mg0
Part A Dose Level 3 NM21-1480-Q2W 8mg0
Part A Dose Level 4 NM21-1480-Q2W 24mg3
Part A Dose Level 5 NM21-1480-Q2W 80mg5
Part A Dose Level 6 NM21-1480-Q2W 240mg3
Part A Dose Level 7 NM21-1480-Q2W 800mg8
Part A2 NM21-1480-Q2W4
Part B NM21-1480-Q2W4

Reported measurements

Source class 1
Values in L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A Dose Level 4 NM21-1480-Q2W 24mg4.1550.9071Not reportedNot reportedNot reported
Part A Dose Level 5 NM21-1480-Q2W 80mg5.8822.263Not reportedNot reportedNot reported
Part A Dose Level 6 NM21-1480-Q2W 240mg6.6743.379Not reportedNot reportedNot reported
Part A Dose Level 7 NM21-1480-Q2W 800mg4.9520.6848Not reportedNot reportedNot reported
Part A2 NM21-1480-Q2W4.4540.9507Not reportedNot reportedNot reported
Part B NM21-1480-Q2W5.9302.472Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG003
        spread
        0.9071
        value
        4.155
      2. group Id
        OG004
        spread
        2.263
        value
        5.882
      3. group Id
        OG005
        spread
        3.379
        value
        6.674
      4. group Id
        OG006
        spread
        0.6848
        value
        4.952
      5. group Id
        OG007
        spread
        0.9507
        value
        4.454
      6. group Id
        OG008
        spread
        2.472
        value
        5.930
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      5
    6. group Id
      OG005
      value
      3
    7. group Id
      OG006
      value
      8
    8. group Id
      OG007
      value
      4
    9. group Id
      OG008
      value
      4
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    Flat dose level; 0.15mg (Dose Level 1)
    id
    OG000
    title
    Part A Dose Level 1 NM21-1480-Q2W 0.15mg
  2. description
    Flat dose level; 1.5mg (Dose Level 2)
    id
    OG001
    title
    Part A Dose Level 2 NM21-1480-Q2W 1.5mg
  3. description
    Flat dose level; 8mg (Dose Level 3)
    id
    OG002
    title
    Part A Dose Level 3 NM21-1480-Q2W 8mg
  4. description
    Flat dose level; 24mg (Dose Level 4)
    id
    OG003
    title
    Part A Dose Level 4 NM21-1480-Q2W 24mg
  5. description
    Flat dose level; 80mg (Dose Level 5)
    id
    OG004
    title
    Part A Dose Level 5 NM21-1480-Q2W 80mg
  6. description
    Flat dose level; 240mg (Dose Level 6)
    id
    OG005
    title
    Part A Dose Level 6 NM21-1480-Q2W 240mg
  7. description
    Flat dose level; mg800 (Dose Level 7)
    id
    OG006
    title
    Part A Dose Level 7 NM21-1480-Q2W 800mg
  8. description
    This part of the study consisted of a 1400mg flat dose across one cohort.
    id
    OG007
    title
    Part A2 NM21-1480-Q2W
  9. description
    This part of the study consisted of a 800mg flat dose across three cohorts.
    id
    OG008
    title
    Part B NM21-1480-Q2W
param Type
MEAN
population Description
Assessment of the volume of distribution (Vd) determined at C1 for all dose levels with the exception of Part A Dose Level 1,2 and 3. Lower limit of quantification (LLOQ) of NM21-1480 = 5 ng/mL.
reporting Status
POSTED
time Frame
From baseline to up to 12 weeks post last dose, up to 48 weeks.
title
Assessment of the Volume of Distribution (Vd)
type
SECONDARY
unit Of Measure
L

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

Preserved source evidence · Not medical advice