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NCT02669017 · OUTCOME

Terminal Half-life (Thalf) of ADCT-402

Study of ADCT-402 in Patients With Relapsed or Refractory B-cell Lineage Non Hodgkin Lymphoma (B-NHL) · Source last updated 2021-05-19

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

Measure
MEDIAN
Unit
days
Interval / dispersion
Full Range
Time frame
Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)

What was measured

Thalf of Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199). Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.

Analysis population: Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.

Groups in this outcome

Part 1: 15 μg/kg Q3W

Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).

Part 1: 30 μg/kg Q3W

Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).

Part 1: 60 μg/kg Q3W

Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).

Part 1: 90 μg/kg Q3W

Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).

Parts 1 and 2: 120 μg/kg Q3W

Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.

Parts 1 and 2: 150 μg/kg Q3W

Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.

Part 1: 200 μg/kg Q3W

Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.

Part 1: 200 μg/kg Q6W

Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 6 week cycle (Q6W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.

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 1: 15 μg/kg Q3W4
Part 1: 30 μg/kg Q3W4
Part 1: 60 μg/kg Q3W2
Part 1: 90 μg/kg Q3W4
Parts 1 and 2: 120 μg/kg Q3W38
Parts 1 and 2: 150 μg/kg Q3W69
Part 1: 200 μg/kg Q3W11
Part 1: 200 μg/kg Q6W13

Reported measurements

PBD conjugated Ab: Cycle 1

Analysis denominator · Participants

GroupSource count
Part 1: 15 μg/kg Q3W3
Part 1: 30 μg/kg Q3W2
Part 1: 60 μg/kg Q3W2
Part 1: 90 μg/kg Q3W2
Parts 1 and 2: 120 μg/kg Q3W15
Parts 1 and 2: 150 μg/kg Q3W47
Part 1: 200 μg/kg Q3W4
Part 1: 200 μg/kg Q6W13
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: 15 μg/kg Q3W1.15Not reported1.042.56Not reported
Part 1: 30 μg/kg Q3W6.84Not reported5.747.94Not reported
Part 1: 60 μg/kg Q3W6.30Not reported4.308.30Not reported
Part 1: 90 μg/kg Q3W3.97Not reported0.9237.01Not reported
Parts 1 and 2: 120 μg/kg Q3W6.33Not reported0.5159.50Not reported
Parts 1 and 2: 150 μg/kg Q3W6.43Not reported0.14613.1Not reported
Part 1: 200 μg/kg Q3W7.96Not reported6.4316.6Not reported
Part 1: 200 μg/kg Q6W10.4Not reported0.056019.6Not reported
PBD conjugated Ab: Cycle 2

Analysis denominator · Participants

GroupSource count
Part 1: 15 μg/kg Q3W4
Part 1: 30 μg/kg Q3W4
Part 1: 60 μg/kg Q3W2
Part 1: 90 μg/kg Q3W4
Parts 1 and 2: 120 μg/kg Q3W38
Parts 1 and 2: 150 μg/kg Q3W69
Part 1: 200 μg/kg Q3W11
Part 1: 200 μg/kg Q6W12
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: 15 μg/kg Q3W3.98Not reported0.90911.1Not reported
Part 1: 30 μg/kg Q3W10.1Not reported6.7217.1Not reported
Part 1: 60 μg/kg Q3W16.3Not reported11.121.4Not reported
Part 1: 90 μg/kg Q3W11.4Not reported1.7819.2Not reported
Parts 1 and 2: 120 μg/kg Q3W12.5Not reported1.7428.7Not reported
Parts 1 and 2: 150 μg/kg Q3W11.6Not reported1.5033.0Not reported
Part 1: 200 μg/kg Q3W16.3Not reported8.1428.8Not reported
Part 1: 200 μg/kg Q6W15.5Not reported4.8225.0Not reported
total Ab: Cycle 1

Analysis denominator · Participants

GroupSource count
Part 1: 15 μg/kg Q3W1
Part 1: 30 μg/kg Q3W0
Part 1: 60 μg/kg Q3W0
Part 1: 90 μg/kg Q3W1
Parts 1 and 2: 120 μg/kg Q3W12
Parts 1 and 2: 150 μg/kg Q3W37
Part 1: 200 μg/kg Q3W2
Part 1: 200 μg/kg Q6W12
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: 15 μg/kg Q3W2.75Not reported2.752.75Not reported
Part 1: 90 μg/kg Q3W8.82Not reported8.828.82Not reported
Parts 1 and 2: 120 μg/kg Q3W7.00Not reported0.32510.6Not reported
Parts 1 and 2: 150 μg/kg Q3W6.58Not reported0.075917.7Not reported
Part 1: 200 μg/kg Q3W9.39Not reported0.66118.1Not reported
Part 1: 200 μg/kg Q6W12.7Not reported0.24819.0Not reported
total Ab: Cycle 2

Analysis denominator · Participants

GroupSource count
Part 1: 15 μg/kg Q3W4
Part 1: 30 μg/kg Q3W3
Part 1: 60 μg/kg Q3W2
Part 1: 90 μg/kg Q3W4
Parts 1 and 2: 120 μg/kg Q3W34
Parts 1 and 2: 150 μg/kg Q3W66
Part 1: 200 μg/kg Q3W10
Part 1: 200 μg/kg Q6W12
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: 15 μg/kg Q3W3.71Not reported0.86013.0Not reported
Part 1: 30 μg/kg Q3W9.58Not reported7.1115.4Not reported
Part 1: 60 μg/kg Q3W16.5Not reported12.920.0Not reported
Part 1: 90 μg/kg Q3W13.4Not reported1.2738.5Not reported
Parts 1 and 2: 120 μg/kg Q3W14.9Not reported2.0733.5Not reported
Parts 1 and 2: 150 μg/kg Q3W14.3Not reported0.26936.0Not reported
Part 1: 200 μg/kg Q3W14.7Not reported8.4727.8Not reported
Part 1: 200 μg/kg Q6W18.4Not reported6.1839.9Not reported
SG3199: Cycle 1

Analysis denominator · Participants

GroupSource count
Part 1: 15 μg/kg Q3W0
Part 1: 30 μg/kg Q3W0
Part 1: 60 μg/kg Q3W0
Part 1: 90 μg/kg Q3W0
Parts 1 and 2: 120 μg/kg Q3W0
Parts 1 and 2: 150 μg/kg Q3W0
Part 1: 200 μg/kg Q3W0
Part 1: 200 μg/kg Q6W0
SG3199: Cycle 2

Analysis denominator · Participants

GroupSource count
Part 1: 15 μg/kg Q3W0
Part 1: 30 μg/kg Q3W0
Part 1: 60 μg/kg Q3W0
Part 1: 90 μg/kg Q3W0
Parts 1 and 2: 120 μg/kg Q3W0
Parts 1 and 2: 150 μg/kg Q3W0
Part 1: 200 μg/kg Q3W0
Part 1: 200 μg/kg Q6W0
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.04
        upper Limit
        2.56
        value
        1.15
      2. group Id
        OG001
        lower Limit
        5.74
        upper Limit
        7.94
        value
        6.84
      3. group Id
        OG002
        lower Limit
        4.30
        upper Limit
        8.30
        value
        6.30
      4. group Id
        OG003
        lower Limit
        0.923
        upper Limit
        7.01
        value
        3.97
      5. group Id
        OG004
        lower Limit
        0.515
        upper Limit
        9.50
        value
        6.33
      6. group Id
        OG005
        lower Limit
        0.146
        upper Limit
        13.1
        value
        6.43
      7. group Id
        OG006
        lower Limit
        6.43
        upper Limit
        16.6
        value
        7.96
      8. group Id
        OG007
        lower Limit
        0.0560
        upper Limit
        19.6
        value
        10.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        15
      6. group Id
        OG005
        value
        47
      7. group Id
        OG006
        value
        4
      8. group Id
        OG007
        value
        13
      units
      Participants
    title
    PBD conjugated Ab: Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.909
        upper Limit
        11.1
        value
        3.98
      2. group Id
        OG001
        lower Limit
        6.72
        upper Limit
        17.1
        value
        10.1
      3. group Id
        OG002
        lower Limit
        11.1
        upper Limit
        21.4
        value
        16.3
      4. group Id
        OG003
        lower Limit
        1.78
        upper Limit
        19.2
        value
        11.4
      5. group Id
        OG004
        lower Limit
        1.74
        upper Limit
        28.7
        value
        12.5
      6. group Id
        OG005
        lower Limit
        1.50
        upper Limit
        33.0
        value
        11.6
      7. group Id
        OG006
        lower Limit
        8.14
        upper Limit
        28.8
        value
        16.3
      8. group Id
        OG007
        lower Limit
        4.82
        upper Limit
        25.0
        value
        15.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        38
      6. group Id
        OG005
        value
        69
      7. group Id
        OG006
        value
        11
      8. group Id
        OG007
        value
        12
      units
      Participants
    title
    PBD conjugated Ab: Cycle 2
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.75
        upper Limit
        2.75
        value
        2.75
      2. group Id
        OG003
        lower Limit
        8.82
        upper Limit
        8.82
        value
        8.82
      3. group Id
        OG004
        lower Limit
        0.325
        upper Limit
        10.6
        value
        7.00
      4. group Id
        OG005
        lower Limit
        0.0759
        upper Limit
        17.7
        value
        6.58
      5. group Id
        OG006
        lower Limit
        0.661
        upper Limit
        18.1
        value
        9.39
      6. group Id
        OG007
        lower Limit
        0.248
        upper Limit
        19.0
        value
        12.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        12
      6. group Id
        OG005
        value
        37
      7. group Id
        OG006
        value
        2
      8. group Id
        OG007
        value
        12
      units
      Participants
    title
    total Ab: Cycle 1
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.860
        upper Limit
        13.0
        value
        3.71
      2. group Id
        OG001
        lower Limit
        7.11
        upper Limit
        15.4
        value
        9.58
      3. group Id
        OG002
        lower Limit
        12.9
        upper Limit
        20.0
        value
        16.5
      4. group Id
        OG003
        lower Limit
        1.27
        upper Limit
        38.5
        value
        13.4
      5. group Id
        OG004
        lower Limit
        2.07
        upper Limit
        33.5
        value
        14.9
      6. group Id
        OG005
        lower Limit
        0.269
        upper Limit
        36.0
        value
        14.3
      7. group Id
        OG006
        lower Limit
        8.47
        upper Limit
        27.8
        value
        14.7
      8. group Id
        OG007
        lower Limit
        6.18
        upper Limit
        39.9
        value
        18.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        34
      6. group Id
        OG005
        value
        66
      7. group Id
        OG006
        value
        10
      8. group Id
        OG007
        value
        12
      units
      Participants
    title
    total Ab: Cycle 2
  5. 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
      units
      Participants
    title
    SG3199: Cycle 1
  6. 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
      units
      Participants
    title
    SG3199: Cycle 2
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      2
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      38
    6. group Id
      OG005
      value
      69
    7. group Id
      OG006
      value
      11
    8. group Id
      OG007
      value
      13
    units
    Participants
description
Thalf of Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199). Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
dispersion Type
Full Range
groups
  1. description
    Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    OG000
    title
    Part 1: 15 μg/kg Q3W
  2. description
    Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    OG001
    title
    Part 1: 30 μg/kg Q3W
  3. description
    Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    OG002
    title
    Part 1: 60 μg/kg Q3W
  4. description
    Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    OG003
    title
    Part 1: 90 μg/kg Q3W
  5. description
    Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
    id
    OG004
    title
    Parts 1 and 2: 120 μg/kg Q3W
  6. description
    Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
    id
    OG005
    title
    Parts 1 and 2: 150 μg/kg Q3W
  7. description
    Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
    id
    OG006
    title
    Part 1: 200 μg/kg Q3W
  8. description
    Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 6 week cycle (Q6W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
    id
    OG007
    title
    Part 1: 200 μg/kg Q6W
param Type
MEDIAN
population Description
Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
reporting Status
POSTED
time Frame
Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
title
Terminal Half-life (Thalf) of ADCT-402
type
SECONDARY
unit Of Measure
days

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Preserved source evidence · Not medical advice