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NCT05047536 · OUTCOME

Maximum Plasma Concentration of KZR-261 (Part 1)

KZR-261 in Subjects With Advanced Solid Malignancies · Source last updated 2025-12-19

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

Measure
GEOMETRIC_MEAN
Unit
ng/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1: Day 1, Cycle 1: Day 15, Cycle 2: Day 1, and Cycle 2: Day 15

What was measured

This is the maximum observed plasma concentration (Cmax) observed after administration of KZR-261 in Cycle 1 (Days 1 and 15) and Cycle 2 (Days 1 and 15). The PK parameters were calculated using all timepoints at which the concentration was measured, ie. predose, 15 minutes post start of infusion, end of infusion, and 5, 15, 30 minutes, 1, 2, 4, 6, 24, 48, and 96 hours post infusion.

Analysis population: The PK analyses were performed for all subjects in the PK population (all subjects that received at least one dose plasma KZR-261 concentration measurement during Cycles 1 and 2 of treatment).

Groups in this outcome

Dose 1

Participants received 1.8 mg/m\^2 of KZR-261.

Dose 2

Participants received 3.6 mg/m\^2 of KZR-261.

Dose 3

Participants received 7.2 mg/m\^2 of KZR-261.

Dose 4

Participants received 12 mg/m\^2 of KZR-261.

Dose 5

Participants received 18 mg/m\^2 of KZR-261.

Dose 6

Participants received 27 mg/m\^2 of KZR-261.

Dose 7

Participants received 40 mg/m\^2 of KZR-261.

Dose 8

Participants received 60 mg/m\^2 of KZR-261.

Dose 9

Participants received 80 mg/m\^2 of KZR-261.

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

Analysis denominator · Participants

GroupSource count
Dose 12
Dose 22
Dose 32
Dose 45
Dose 56
Dose 66
Dose 75
Dose 817
Dose 98

Reported measurements

Cycle 1, Day 1

Analysis denominator · Participants

GroupSource count
Dose 12
Dose 22
Dose 32
Dose 45
Dose 56
Dose 66
Dose 75
Dose 817
Dose 98
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Dose 1601.526.9Not reportedNot reportedNot reported
Dose 21414.91.5Not reportedNot reportedNot reported
Dose 31536.134.7Not reportedNot reportedNot reported
Dose 42793.544.9Not reportedNot reportedNot reported
Dose 55126.637.8Not reportedNot reportedNot reported
Dose 67475.810.9Not reportedNot reportedNot reported
Dose 79531.239.5Not reportedNot reportedNot reported
Dose 812159.827.8Not reportedNot reportedNot reported
Dose 916346.527.4Not reportedNot reportedNot reported
Cycle 1, Day 15

Analysis denominator · Participants

GroupSource count
Dose 12
Dose 21
Dose 32
Dose 45
Dose 55
Dose 66
Dose 75
Dose 815
Dose 95
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Dose 1580.635.5Not reportedNot reportedNot reported
Dose 22160.0NANot reportedNot reportedThe measure was only collected for one participant.
Dose 32413.246.0Not reportedNot reportedNot reported
Dose 44149.845.6Not reportedNot reportedNot reported
Dose 54409.640.2Not reportedNot reportedNot reported
Dose 67571.723.8Not reportedNot reportedNot reported
Dose 711906.823.6Not reportedNot reportedNot reported
Dose 812917.136.0Not reportedNot reportedNot reported
Dose 925955.5154.2Not reportedNot reportedNot reported
Cycle 2, Day 1

Analysis denominator · Participants

GroupSource count
Dose 12
Dose 22
Dose 32
Dose 43
Dose 55
Dose 64
Dose 74
Dose 810
Dose 93
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Dose 1566.513.3Not reportedNot reportedNot reported
Dose 21724.446.7Not reportedNot reportedNot reported
Dose 32406.657.4Not reportedNot reportedNot reported
Dose 43712.854.5Not reportedNot reportedNot reported
Dose 54359.118.7Not reportedNot reportedNot reported
Dose 66686.221.1Not reportedNot reportedNot reported
Dose 714497.642.2Not reportedNot reportedNot reported
Dose 812208.536.0Not reportedNot reportedNot reported
Dose 931491.0260.2Not reportedNot reportedNot reported
Cycle 2, Day 15

Analysis denominator · Participants

GroupSource count
Dose 12
Dose 22
Dose 32
Dose 42
Dose 54
Dose 64
Dose 74
Dose 85
Dose 91
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Dose 1603.220.7Not reportedNot reportedNot reported
Dose 21334.661.3Not reportedNot reportedNot reported
Dose 32128.836.3Not reportedNot reportedNot reported
Dose 43510.727.5Not reportedNot reportedNot reported
Dose 54409.628.6Not reportedNot reportedNot reported
Dose 67343.524.9Not reportedNot reportedNot reported
Dose 712218.511.0Not reportedNot reportedNot reported
Dose 815342.731.4Not reportedNot reportedNot reported
Dose 918300.0NANot reportedNot reportedThe measure was only collected for one participant.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        26.9
        value
        601.5
      2. group Id
        OG001
        spread
        1.5
        value
        1414.9
      3. group Id
        OG002
        spread
        34.7
        value
        1536.1
      4. group Id
        OG003
        spread
        44.9
        value
        2793.5
      5. group Id
        OG004
        spread
        37.8
        value
        5126.6
      6. group Id
        OG005
        spread
        10.9
        value
        7475.8
      7. group Id
        OG006
        spread
        39.5
        value
        9531.2
      8. group Id
        OG007
        spread
        27.8
        value
        12159.8
      9. group Id
        OG008
        spread
        27.4
        value
        16346.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        5
      5. group Id
        OG004
        value
        6
      6. group Id
        OG005
        value
        6
      7. group Id
        OG006
        value
        5
      8. group Id
        OG007
        value
        17
      9. group Id
        OG008
        value
        8
      units
      Participants
    title
    Cycle 1, Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        35.5
        value
        580.6
      2. comment
        The measure was only collected for one participant.
        group Id
        OG001
        spread
        NA
        value
        2160.0
      3. group Id
        OG002
        spread
        46.0
        value
        2413.2
      4. group Id
        OG003
        spread
        45.6
        value
        4149.8
      5. group Id
        OG004
        spread
        40.2
        value
        4409.6
      6. group Id
        OG005
        spread
        23.8
        value
        7571.7
      7. group Id
        OG006
        spread
        23.6
        value
        11906.8
      8. group Id
        OG007
        spread
        36.0
        value
        12917.1
      9. group Id
        OG008
        spread
        154.2
        value
        25955.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        5
      5. group Id
        OG004
        value
        5
      6. group Id
        OG005
        value
        6
      7. group Id
        OG006
        value
        5
      8. group Id
        OG007
        value
        15
      9. group Id
        OG008
        value
        5
      units
      Participants
    title
    Cycle 1, Day 15
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.3
        value
        566.5
      2. group Id
        OG001
        spread
        46.7
        value
        1724.4
      3. group Id
        OG002
        spread
        57.4
        value
        2406.6
      4. group Id
        OG003
        spread
        54.5
        value
        3712.8
      5. group Id
        OG004
        spread
        18.7
        value
        4359.1
      6. group Id
        OG005
        spread
        21.1
        value
        6686.2
      7. group Id
        OG006
        spread
        42.2
        value
        14497.6
      8. group Id
        OG007
        spread
        36.0
        value
        12208.5
      9. group Id
        OG008
        spread
        260.2
        value
        31491.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        5
      6. group Id
        OG005
        value
        4
      7. group Id
        OG006
        value
        4
      8. group Id
        OG007
        value
        10
      9. group Id
        OG008
        value
        3
      units
      Participants
    title
    Cycle 2, Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.7
        value
        603.2
      2. group Id
        OG001
        spread
        61.3
        value
        1334.6
      3. group Id
        OG002
        spread
        36.3
        value
        2128.8
      4. group Id
        OG003
        spread
        27.5
        value
        3510.7
      5. group Id
        OG004
        spread
        28.6
        value
        4409.6
      6. group Id
        OG005
        spread
        24.9
        value
        7343.5
      7. group Id
        OG006
        spread
        11.0
        value
        12218.5
      8. group Id
        OG007
        spread
        31.4
        value
        15342.7
      9. comment
        The measure was only collected for one participant.
        group Id
        OG008
        spread
        NA
        value
        18300.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        4
      7. group Id
        OG006
        value
        4
      8. group Id
        OG007
        value
        5
      9. group Id
        OG008
        value
        1
      units
      Participants
    title
    Cycle 2, Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      2
    4. group Id
      OG003
      value
      5
    5. group Id
      OG004
      value
      6
    6. group Id
      OG005
      value
      6
    7. group Id
      OG006
      value
      5
    8. group Id
      OG007
      value
      17
    9. group Id
      OG008
      value
      8
    units
    Participants
description
This is the maximum observed plasma concentration (Cmax) observed after administration of KZR-261 in Cycle 1 (Days 1 and 15) and Cycle 2 (Days 1 and 15). The PK parameters were calculated using all timepoints at which the concentration was measured, ie. predose, 15 minutes post start of infusion, end of infusion, and 5, 15, 30 minutes, 1, 2, 4, 6, 24, 48, and 96 hours post infusion.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received 1.8 mg/m\^2 of KZR-261.
    id
    OG000
    title
    Dose 1
  2. description
    Participants received 3.6 mg/m\^2 of KZR-261.
    id
    OG001
    title
    Dose 2
  3. description
    Participants received 7.2 mg/m\^2 of KZR-261.
    id
    OG002
    title
    Dose 3
  4. description
    Participants received 12 mg/m\^2 of KZR-261.
    id
    OG003
    title
    Dose 4
  5. description
    Participants received 18 mg/m\^2 of KZR-261.
    id
    OG004
    title
    Dose 5
  6. description
    Participants received 27 mg/m\^2 of KZR-261.
    id
    OG005
    title
    Dose 6
  7. description
    Participants received 40 mg/m\^2 of KZR-261.
    id
    OG006
    title
    Dose 7
  8. description
    Participants received 60 mg/m\^2 of KZR-261.
    id
    OG007
    title
    Dose 8
  9. description
    Participants received 80 mg/m\^2 of KZR-261.
    id
    OG008
    title
    Dose 9
param Type
GEOMETRIC_MEAN
population Description
The PK analyses were performed for all subjects in the PK population (all subjects that received at least one dose plasma KZR-261 concentration measurement during Cycles 1 and 2 of treatment).
reporting Status
POSTED
time Frame
Cycle 1: Day 1, Cycle 1: Day 15, Cycle 2: Day 1, and Cycle 2: Day 15
title
Maximum Plasma Concentration of KZR-261 (Part 1)
type
PRIMARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice