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NCT02988817 · OUTCOME

Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part

Enapotamab Vedotin (HuMax-AXL-ADC) Safety Study in Patients With Solid Tumors · Source last updated 2023-08-01

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

Measure
GEOMETRIC_MEAN
Unit
L/day
Interval / dispersion
Geometric Coefficient of Variation
Time frame
For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3

What was measured

The total CL of conjugated enapotamab vedotin in dose-escalation part is reported.

Analysis population: The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.

Groups in this outcome

Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.

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-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W1
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W1
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W3
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W3
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W10
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W11
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W3
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W3
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W3
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W6
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W3

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W1
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W1
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W3
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W3
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W10
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W10
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W3
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W0
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W0
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W0
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W0
Values in L/day · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W4.053NANot reportedNot reportedGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W3.446NANot reportedNot reportedGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W3.53821.8Not reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W2.30728.3Not reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W2.20222.2Not reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W2.20525.4Not reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W1.78324.3Not reportedNot reportedNot reported
Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W0
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W0
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W0
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W0
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W0
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W0
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W0
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W3
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W3
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W6
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W1
Values in L/day · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W3.6799.4Not reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W3.08493.8Not reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W3.40231.3Not reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W2.629NANot reportedNot reportedGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
Cycle 3 day 1

Analysis denominator · Participants

GroupSource count
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W1
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W1
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W1
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W1
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W8
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W4
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W0
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W0
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W0
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W0
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W0
Values in L/day · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W4.360NANot reportedNot reportedGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W4.187NANot reportedNot reportedGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W3.000NANot reportedNot reportedGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W2.160NANot reportedNot reportedGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W2.28527.1Not reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W2.53914.7Not reportedNot reportedNot reported
Cycle 3 Day 15

Analysis denominator · Participants

GroupSource count
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W0
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W0
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W0
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W0
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W0
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W0
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W0
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W0
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W1
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W1
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W0
Values in L/day · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W2.281NANot reportedNot reportedGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W3.412NANot reportedNot reportedGeometric coefficient of variation was not derived as only one participant was evaluated for this arm.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
        group Id
        OG000
        spread
        NA
        value
        4.053
      2. comment
        Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
        group Id
        OG001
        spread
        NA
        value
        3.446
      3. group Id
        OG002
        spread
        21.8
        value
        3.538
      4. group Id
        OG003
        spread
        28.3
        value
        2.307
      5. group Id
        OG004
        spread
        22.2
        value
        2.202
      6. group Id
        OG005
        spread
        25.4
        value
        2.205
      7. group Id
        OG006
        spread
        24.3
        value
        1.783
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        10
      6. group Id
        OG005
        value
        10
      7. group Id
        OG006
        value
        3
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG007
        spread
        9.4
        value
        3.679
      2. group Id
        OG008
        spread
        93.8
        value
        3.084
      3. group Id
        OG009
        spread
        31.3
        value
        3.402
      4. comment
        Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
        group Id
        OG010
        spread
        NA
        value
        2.629
    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
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        3
      9. group Id
        OG008
        value
        3
      10. group Id
        OG009
        value
        6
      11. group Id
        OG010
        value
        1
      units
      Participants
    title
    Cycle 1 Day 15
  3. categories
    1. measurements
      1. comment
        Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
        group Id
        OG000
        spread
        NA
        value
        4.360
      2. comment
        Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
        group Id
        OG001
        spread
        NA
        value
        4.187
      3. comment
        Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
        group Id
        OG002
        spread
        NA
        value
        3.000
      4. comment
        Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
        group Id
        OG003
        spread
        NA
        value
        2.160
      5. group Id
        OG004
        spread
        27.1
        value
        2.285
      6. group Id
        OG005
        spread
        14.7
        value
        2.539
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        8
      6. group Id
        OG005
        value
        4
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      units
      Participants
    title
    Cycle 3 day 1
  4. categories
    1. measurements
      1. comment
        Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
        group Id
        OG008
        spread
        NA
        value
        2.281
      2. comment
        Geometric coefficient of variation was not derived as only one participant was evaluated for this arm.
        group Id
        OG009
        spread
        NA
        value
        3.412
    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
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        1
      11. group Id
        OG010
        value
        0
      units
      Participants
    title
    Cycle 3 Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      10
    6. group Id
      OG005
      value
      11
    7. group Id
      OG006
      value
      3
    8. group Id
      OG007
      value
      3
    9. group Id
      OG008
      value
      3
    10. group Id
      OG009
      value
      6
    11. group Id
      OG010
      value
      3
    units
    Participants
description
The total CL of conjugated enapotamab vedotin in dose-escalation part is reported.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
    id
    OG000
    title
    Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
  2. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
    id
    OG001
    title
    Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
  3. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
    id
    OG002
    title
    Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
  4. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
    id
    OG003
    title
    Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
  5. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
    id
    OG004
    title
    Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
  6. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
    id
    OG005
    title
    Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
  7. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
    id
    OG006
    title
    Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
  8. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
    id
    OG007
    title
    Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
  9. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
    id
    OG008
    title
    Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
  10. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
    id
    OG009
    title
    Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
  11. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
    id
    OG010
    title
    Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
param Type
GEOMETRIC_MEAN
population Description
The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
reporting Status
POSTED
time Frame
For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
title
Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part
type
SECONDARY
unit Of Measure
L/day

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Preserved source evidence · Not medical advice