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NCT02988817 · OUTCOME

t1/2 of MMAE for 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
MEDIAN
Unit
Day
Interval / dispersion
Full Range
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: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3

What was measured

The t1/2 of MMAE for 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 1Q3W2
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 Day · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W2.19Not reported2.192.19Not reported
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W2.35Not reported2.352.35Not reported
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W2.470Not reported2.102.70Not reported
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W2.620Not reported1.852.98Not reported
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W2.420Not reported2.023.75Not reported
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W3.128Not reported1.5542.73Not reported
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W2.835Not reported2.453.22Not 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 3Q4W0
Values in Day · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W3.976Not reported2.786.06Not reported
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W3.115Not reported2.495.04Not reported
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W4.739Not reported2.858.70Not reported
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 1Q3W1
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 Day · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W1.94Not reported1.941.94Not reported
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W2.32Not reported2.322.32Not reported
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W2.71Not reported2.712.71Not reported
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W2.52Not reported2.522.52Not reported
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W2.746Not reported2.183.12Not reported
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W3.364Not reported2.854.99Not reported
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W1.98Not reported1.981.98Not 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 Day · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W2.330Not reported2.332.33Not reported
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W3.37Not reported3.373.37Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.19
        upper Limit
        2.19
        value
        2.19
      2. group Id
        OG001
        lower Limit
        2.35
        upper Limit
        2.35
        value
        2.35
      3. group Id
        OG002
        lower Limit
        2.10
        upper Limit
        2.70
        value
        2.470
      4. group Id
        OG003
        lower Limit
        1.85
        upper Limit
        2.98
        value
        2.620
      5. group Id
        OG004
        lower Limit
        2.02
        upper Limit
        3.75
        value
        2.420
      6. group Id
        OG005
        lower Limit
        1.55
        upper Limit
        42.73
        value
        3.128
      7. group Id
        OG006
        lower Limit
        2.45
        upper Limit
        3.22
        value
        2.835
    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
        2
      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
        lower Limit
        2.78
        upper Limit
        6.06
        value
        3.976
      2. group Id
        OG008
        lower Limit
        2.49
        upper Limit
        5.04
        value
        3.115
      3. group Id
        OG009
        lower Limit
        2.85
        upper Limit
        8.70
        value
        4.739
    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
        0
      units
      Participants
    title
    Cycle 1 Day 15
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.94
        upper Limit
        1.94
        value
        1.94
      2. group Id
        OG001
        lower Limit
        2.32
        upper Limit
        2.32
        value
        2.32
      3. group Id
        OG002
        lower Limit
        2.71
        upper Limit
        2.71
        value
        2.71
      4. group Id
        OG003
        lower Limit
        2.52
        upper Limit
        2.52
        value
        2.52
      5. group Id
        OG004
        lower Limit
        2.18
        upper Limit
        3.12
        value
        2.746
      6. group Id
        OG005
        lower Limit
        2.85
        upper Limit
        4.99
        value
        3.364
      7. group Id
        OG006
        lower Limit
        1.98
        upper Limit
        1.98
        value
        1.98
    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
        1
      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. group Id
        OG008
        lower Limit
        2.33
        upper Limit
        2.33
        value
        2.330
      2. group Id
        OG009
        lower Limit
        3.37
        upper Limit
        3.37
        value
        3.37
    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 t1/2 of MMAE for dose-escalation part is reported.
dispersion Type
Full Range
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
MEDIAN
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: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3
title
t1/2 of MMAE for Dose-escalation Part
type
SECONDARY
unit Of Measure
Day

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Preserved source evidence · Not medical advice