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NCT05047536 · OUTCOME

The Plasma Concentration Time Curve 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
hr*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 area under the curve (AUC) from predose through postdose 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, and 24 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 hr*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Dose 1653.214.5Not reportedNot reportedNot reported
Dose 21483.4101.6Not reportedNot reportedNot reported
Dose 32252.713.7Not reportedNot reportedNot reported
Dose 45592.074.6Not reportedNot reportedNot reported
Dose 56427.130.8Not reportedNot reportedNot reported
Dose 69919.211.1Not reportedNot reportedNot reported
Dose 715766.715.3Not reportedNot reportedNot reported
Dose 822918.945.4Not reportedNot reportedNot reported
Dose 934948.331.7Not 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 hr*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Dose 1528.620.5Not reportedNot reportedNot reported
Dose 22596.4NANot reportedNot reportedOnly one participant had measurements at this timepoint.
Dose 32511.242.4Not reportedNot reportedNot reported
Dose 44259.126.4Not reportedNot reportedNot reported
Dose 56280.131.8Not reportedNot reportedNot reported
Dose 68944.016.4Not reportedNot reportedNot reported
Dose 714624.813.9Not reportedNot reportedNot reported
Dose 818088.127.0Not reportedNot reportedNot reported
Dose 938084.696.2Not 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 hr*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Dose 1532.22.9Not reportedNot reportedNot reported
Dose 21506.868.2Not reportedNot reportedNot reported
Dose 32485.012.1Not reportedNot reportedNot reported
Dose 46536.580.4Not reportedNot reportedNot reported
Dose 57030.021.6Not reportedNot reportedNot reported
Dose 610171.018.0Not reportedNot reportedNot reported
Dose 720581.536.2Not reportedNot reportedNot reported
Dose 820847.357.6Not reportedNot reportedNot reported
Dose 948172.792.3Not 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 hr*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Dose 1568.621.8Not reportedNot reportedNot reported
Dose 21304.578.3Not reportedNot reportedNot reported
Dose 32126.422.7Not reportedNot reportedNot reported
Dose 45135.953.6Not reportedNot reportedNot reported
Dose 56246.628.2Not reportedNot reportedNot reported
Dose 68958.023.2Not reportedNot reportedNot reported
Dose 717093.816.0Not reportedNot reportedNot reported
Dose 822390.031.7Not reportedNot reportedNot reported
Dose 937991.6NANot reportedNot reportedOnly one participant had measurements at this timepoint.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.5
        value
        653.2
      2. group Id
        OG001
        spread
        101.6
        value
        1483.4
      3. group Id
        OG002
        spread
        13.7
        value
        2252.7
      4. group Id
        OG003
        spread
        74.6
        value
        5592.0
      5. group Id
        OG004
        spread
        30.8
        value
        6427.1
      6. group Id
        OG005
        spread
        11.1
        value
        9919.2
      7. group Id
        OG006
        spread
        15.3
        value
        15766.7
      8. group Id
        OG007
        spread
        45.4
        value
        22918.9
      9. group Id
        OG008
        spread
        31.7
        value
        34948.3
    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
        20.5
        value
        528.6
      2. comment
        Only one participant had measurements at this timepoint.
        group Id
        OG001
        spread
        NA
        value
        2596.4
      3. group Id
        OG002
        spread
        42.4
        value
        2511.2
      4. group Id
        OG003
        spread
        26.4
        value
        4259.1
      5. group Id
        OG004
        spread
        31.8
        value
        6280.1
      6. group Id
        OG005
        spread
        16.4
        value
        8944.0
      7. group Id
        OG006
        spread
        13.9
        value
        14624.8
      8. group Id
        OG007
        spread
        27.0
        value
        18088.1
      9. group Id
        OG008
        spread
        96.2
        value
        38084.6
    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
        2.9
        value
        532.2
      2. group Id
        OG001
        spread
        68.2
        value
        1506.8
      3. group Id
        OG002
        spread
        12.1
        value
        2485.0
      4. group Id
        OG003
        spread
        80.4
        value
        6536.5
      5. group Id
        OG004
        spread
        21.6
        value
        7030.0
      6. group Id
        OG005
        spread
        18.0
        value
        10171.0
      7. group Id
        OG006
        spread
        36.2
        value
        20581.5
      8. group Id
        OG007
        spread
        57.6
        value
        20847.3
      9. group Id
        OG008
        spread
        92.3
        value
        48172.7
    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
        21.8
        value
        568.6
      2. group Id
        OG001
        spread
        78.3
        value
        1304.5
      3. group Id
        OG002
        spread
        22.7
        value
        2126.4
      4. group Id
        OG003
        spread
        53.6
        value
        5135.9
      5. group Id
        OG004
        spread
        28.2
        value
        6246.6
      6. group Id
        OG005
        spread
        23.2
        value
        8958.0
      7. group Id
        OG006
        spread
        16.0
        value
        17093.8
      8. group Id
        OG007
        spread
        31.7
        value
        22390.0
      9. comment
        Only one participant had measurements at this timepoint.
        group Id
        OG008
        spread
        NA
        value
        37991.6
    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 area under the curve (AUC) from predose through postdose 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, and 24 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
The Plasma Concentration Time Curve of KZR-261 (Part 1)
type
PRIMARY
unit Of Measure
hr*ng/mL

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Preserved source evidence · Not medical advice