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NCT02460224 · OUTCOME

Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525

Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies. · Source last updated 2022-02-10

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
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).

What was measured

Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.

Analysis population: All patients in phase 1 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.

Groups in this outcome

Phase 1: LAG525 1 mg/kg Q2W

Single-agent LAG525 1 mg/kg Q2W

Phase 1: LAG525 3 mg/kg Q2W

Single-agent LAG525 3 mg/kg Q2W

Phase 1: LAG525 5 mg/kg Q2W

Single-agent LAG525 5 mg/kg Q2W

Phase 1: LAG525 10 mg/kg Q2W

Single-agent LAG525 10 mg/kg Q2W

Phase 1: LAG525 15 mg/kg Q2W

Single-agent LAG525 15 mg/kg Q2W

Phase 1: LAG525 240 mg Q2W

Single-agent LAG525 240 mg Q2W

Phase 1: LAG525 400 mg Q2W

Single-agent LAG525 400 mg Q2W

Phase 1: LAG525 3 mg/kg Q4W

Single-agent LAG525 3 mg/kg Q4W

Phase 1: LAG525 5 mg/kg Q4W

Single-agent LAG525 5 mg/kg Q4W

Phase 1: LAG525 10 mg/kg Q4W

Single-agent LAG525 10 mg/kg Q4W

Phase 1: LAG525 400 mg Q4W

Single-agent LAG525 400 mg Q4W

Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W

Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)

Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W

Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)

Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W

Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)

Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W

Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)

Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W

Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)

Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W

Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)

Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W

Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)

Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W

Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)

Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W

Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)

Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W

Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)

Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W

Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)

Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W

Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)

Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W

Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)

Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W

Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)

Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W

Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)

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

Analysis denominator · Participants

GroupSource count
Phase 1: LAG525 1 mg/kg Q2W17
Phase 1: LAG525 3 mg/kg Q2W12
Phase 1: LAG525 5 mg/kg Q2W6
Phase 1: LAG525 10 mg/kg Q2W6
Phase 1: LAG525 15 mg/kg Q2W6
Phase 1: LAG525 240 mg Q2W29
Phase 1: LAG525 400 mg Q2W30
Phase 1: LAG525 3 mg/kg Q4W5
Phase 1: LAG525 5 mg/kg Q4W6
Phase 1: LAG525 10 mg/kg Q4W11
Phase 1: LAG525 400 mg Q4W5
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W6
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W6
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W6
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W5
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W6
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W20
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W5
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W11
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W7
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W4
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W10
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W6
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W11
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W6
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W6

Reported measurements

Cycle 1, ROW patients

Analysis denominator · Participants

GroupSource count
Phase 1: LAG525 1 mg/kg Q2W12
Phase 1: LAG525 3 mg/kg Q2W12
Phase 1: LAG525 5 mg/kg Q2W6
Phase 1: LAG525 10 mg/kg Q2W6
Phase 1: LAG525 15 mg/kg Q2W6
Phase 1: LAG525 240 mg Q2W24
Phase 1: LAG525 400 mg Q2W23
Phase 1: LAG525 3 mg/kg Q4W5
Phase 1: LAG525 5 mg/kg Q4W6
Phase 1: LAG525 10 mg/kg Q4W6
Phase 1: LAG525 400 mg Q4W5
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W6
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W5
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W6
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W4
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W6
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W16
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W3
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W9
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W7
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W3
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W9
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W5
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W9
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W5
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W6
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1: LAG525 1 mg/kg Q2W1.73Not reported1.52.45Not reported
Phase 1: LAG525 3 mg/kg Q2W1.6Not reported1.12.62Not reported
Phase 1: LAG525 5 mg/kg Q2W1.63Not reported1.172.13Not reported
Phase 1: LAG525 10 mg/kg Q2W1.63Not reported1.52.35Not reported
Phase 1: LAG525 15 mg/kg Q2W1.99Not reported1.482.07Not reported
Phase 1: LAG525 240 mg Q2W1.59Not reported1.52.17Not reported
Phase 1: LAG525 400 mg Q2W1.57Not reported1.472.45Not reported
Phase 1: LAG525 3 mg/kg Q4W1.58Not reported1.032.25Not reported
Phase 1: LAG525 5 mg/kg Q4W2.1Not reported1.52.17Not reported
Phase 1: LAG525 10 mg/kg Q4W2.02Not reported1.52.28Not reported
Phase 1: LAG525 400 mg Q4W1.5Not reported1.51.68Not reported
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W1.5Not reported1.51.65Not reported
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W1.5Not reported0.9331.53Not reported
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W1.5Not reported1.471.52Not reported
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W1.53Not reported1.51.58Not reported
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W1.55Not reported1.52.03Not reported
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W1.52Not reported1.024.25Not reported
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W1.5Not reported1.51.58Not reported
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W1.57Not reported14.45Not reported
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W1.52Not reported1.51.55Not reported
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W1.5Not reported1.51.5Not reported
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W1.58Not reported1.52.07Not reported
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W1.58Not reported1.52.1Not reported
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W1.5Not reported1.52.57Not reported
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W1.7Not reported1.572.08Not reported
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W1.5Not reported01.55Not reported
Cycle 3, ROW patients

Analysis denominator · Participants

GroupSource count
Phase 1: LAG525 1 mg/kg Q2W4
Phase 1: LAG525 3 mg/kg Q2W7
Phase 1: LAG525 5 mg/kg Q2W1
Phase 1: LAG525 10 mg/kg Q2W1
Phase 1: LAG525 15 mg/kg Q2W3
Phase 1: LAG525 240 mg Q2W9
Phase 1: LAG525 400 mg Q2W9
Phase 1: LAG525 3 mg/kg Q4W3
Phase 1: LAG525 5 mg/kg Q4W2
Phase 1: LAG525 10 mg/kg Q4W2
Phase 1: LAG525 400 mg Q4W2
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W3
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W4
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W3
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W3
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W4
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W14
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W2
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W5
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W3
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W2
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W4
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W2
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W6
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W5
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W3
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1: LAG525 1 mg/kg Q2W1.83Not reported1.52.12Not reported
Phase 1: LAG525 3 mg/kg Q2W2.05Not reported1.552.08Not reported
Phase 1: LAG525 5 mg/kg Q2W1.08Not reported1.081.08Not reported
Phase 1: LAG525 10 mg/kg Q2W1.55Not reported1.551.55Not reported
Phase 1: LAG525 15 mg/kg Q2W1.67Not reported1.672.08Not reported
Phase 1: LAG525 240 mg Q2W1.58Not reported1.332.05Not reported
Phase 1: LAG525 400 mg Q2W1.5Not reported1.52.55Not reported
Phase 1: LAG525 3 mg/kg Q4W2.08Not reported1.522.12Not reported
Phase 1: LAG525 5 mg/kg Q4W1.93Not reported1.572.3Not reported
Phase 1: LAG525 10 mg/kg Q4W1.83Not reported1.652Not reported
Phase 1: LAG525 400 mg Q4W1.5Not reported1.51.5Not reported
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W1.72Not reported1.571.83Not reported
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W1.51Not reported1.51.57Not reported
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W1.5Not reported1.51.58Not reported
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W1.5Not reported1.51.52Not reported
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W1.53Not reported1.52Not reported
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W1.53Not reported1.483.77Not reported
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W1.58Not reported1.581.58Not reported
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W1.52Not reported11.55Not reported
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W1.58Not reported1.51.75Not reported
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W1.54Not reported1.51.58Not reported
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W1.58Not reported1.52.05Not reported
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W1.75Not reported1.52Not reported
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W1.53Not reported1.52.55Not reported
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W1.58Not reported02Not reported
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W1.58Not reported1.571.58Not reported
Cycle 1, Japanese patients

Analysis denominator · Participants

GroupSource count
Phase 1: LAG525 1 mg/kg Q2W4
Phase 1: LAG525 3 mg/kg Q2W0
Phase 1: LAG525 5 mg/kg Q2W0
Phase 1: LAG525 10 mg/kg Q2W0
Phase 1: LAG525 15 mg/kg Q2W0
Phase 1: LAG525 240 mg Q2W4
Phase 1: LAG525 400 mg Q2W6
Phase 1: LAG525 3 mg/kg Q4W0
Phase 1: LAG525 5 mg/kg Q4W0
Phase 1: LAG525 10 mg/kg Q4W0
Phase 1: LAG525 400 mg Q4W0
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W0
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W0
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W0
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W0
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W0
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W0
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W0
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W0
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W0
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W0
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W0
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W0
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W0
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W0
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W0
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1: LAG525 1 mg/kg Q2W1.58Not reported1.551.68Not reported
Phase 1: LAG525 240 mg Q2W1.54Not reported1.51.63Not reported
Phase 1: LAG525 400 mg Q2W1.54Not reported1.521.55Not reported
Cycle 3, Japanese patients

Analysis denominator · Participants

GroupSource count
Phase 1: LAG525 1 mg/kg Q2W2
Phase 1: LAG525 3 mg/kg Q2W0
Phase 1: LAG525 5 mg/kg Q2W0
Phase 1: LAG525 10 mg/kg Q2W0
Phase 1: LAG525 15 mg/kg Q2W0
Phase 1: LAG525 240 mg Q2W1
Phase 1: LAG525 400 mg Q2W3
Phase 1: LAG525 3 mg/kg Q4W0
Phase 1: LAG525 5 mg/kg Q4W0
Phase 1: LAG525 10 mg/kg Q4W0
Phase 1: LAG525 400 mg Q4W0
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W0
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W0
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W0
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W0
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W0
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W0
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W0
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W0
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W0
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W0
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W0
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W0
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W0
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W0
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W0
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1: LAG525 1 mg/kg Q2W1.63Not reported1.581.68Not reported
Phase 1: LAG525 240 mg Q2W1.57Not reported1.571.57Not reported
Phase 1: LAG525 400 mg Q2W1.6Not reported1.551.67Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.5
        upper Limit
        2.45
        value
        1.73
      2. group Id
        OG001
        lower Limit
        1.1
        upper Limit
        2.62
        value
        1.6
      3. group Id
        OG002
        lower Limit
        1.17
        upper Limit
        2.13
        value
        1.63
      4. group Id
        OG003
        lower Limit
        1.5
        upper Limit
        2.35
        value
        1.63
      5. group Id
        OG004
        lower Limit
        1.48
        upper Limit
        2.07
        value
        1.99
      6. group Id
        OG005
        lower Limit
        1.5
        upper Limit
        2.17
        value
        1.59
      7. group Id
        OG006
        lower Limit
        1.47
        upper Limit
        2.45
        value
        1.57
      8. group Id
        OG007
        lower Limit
        1.03
        upper Limit
        2.25
        value
        1.58
      9. group Id
        OG008
        lower Limit
        1.5
        upper Limit
        2.17
        value
        2.1
      10. group Id
        OG009
        lower Limit
        1.5
        upper Limit
        2.28
        value
        2.02
      11. group Id
        OG010
        lower Limit
        1.5
        upper Limit
        1.68
        value
        1.5
      12. group Id
        OG011
        lower Limit
        1.5
        upper Limit
        1.65
        value
        1.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        6
      6. group Id
        OG005
        value
        24
      7. group Id
        OG006
        value
        23
      8. group Id
        OG007
        value
        5
      9. group Id
        OG008
        value
        6
      10. group Id
        OG009
        value
        6
      11. group Id
        OG010
        value
        5
      12. group Id
        OG011
        value
        6
      units
      Participants
    title
    Cycle 1, ROW patients
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.5
        upper Limit
        2.12
        value
        1.83
      2. group Id
        OG001
        lower Limit
        1.55
        upper Limit
        2.08
        value
        2.05
      3. group Id
        OG002
        lower Limit
        1.08
        upper Limit
        1.08
        value
        1.08
      4. group Id
        OG003
        lower Limit
        1.55
        upper Limit
        1.55
        value
        1.55
      5. group Id
        OG004
        lower Limit
        1.67
        upper Limit
        2.08
        value
        1.67
      6. group Id
        OG005
        lower Limit
        1.33
        upper Limit
        2.05
        value
        1.58
      7. group Id
        OG006
        lower Limit
        1.5
        upper Limit
        2.55
        value
        1.5
      8. group Id
        OG007
        lower Limit
        1.52
        upper Limit
        2.12
        value
        2.08
      9. group Id
        OG008
        lower Limit
        1.57
        upper Limit
        2.3
        value
        1.93
      10. group Id
        OG009
        lower Limit
        1.65
        upper Limit
        2
        value
        1.83
      11. group Id
        OG010
        lower Limit
        1.5
        upper Limit
        1.5
        value
        1.5
      12. group Id
        OG011
        lower Limit
        1.57
        upper Limit
        1.83
        value
        1.72
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        9
      7. group Id
        OG006
        value
        9
      8. group Id
        OG007
        value
        3
      9. group Id
        OG008
        value
        2
      10. group Id
        OG009
        value
        2
      11. group Id
        OG010
        value
        2
      12. group Id
        OG011
        value
        3
      units
      Participants
    title
    Cycle 3, ROW patients
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.55
        upper Limit
        1.68
        value
        1.58
      2. group Id
        OG005
        lower Limit
        1.5
        upper Limit
        1.63
        value
        1.54
      3. group Id
        OG006
        lower Limit
        1.52
        upper Limit
        1.55
        value
        1.54
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      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
        4
      7. group Id
        OG006
        value
        6
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
      units
      Participants
    title
    Cycle 1, Japanese patients
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.58
        upper Limit
        1.68
        value
        1.63
      2. group Id
        OG005
        lower Limit
        1.57
        upper Limit
        1.57
        value
        1.57
      3. group Id
        OG006
        lower Limit
        1.55
        upper Limit
        1.67
        value
        1.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      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
        1
      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
      12. group Id
        OG011
        value
        0
      units
      Participants
    title
    Cycle 3, Japanese patients
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    2. group Id
      OG001
      value
      12
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      6
    6. group Id
      OG005
      value
      29
    7. group Id
      OG006
      value
      30
    8. group Id
      OG007
      value
      5
    9. group Id
      OG008
      value
      6
    10. group Id
      OG009
      value
      11
    11. group Id
      OG010
      value
      5
    12. group Id
      OG011
      value
      6
    units
    Participants
description
Pharmacokinetic (PK) parameters were calculated based on LAG525 serum concentrations by using non-compartmental methods. Tmax is defined as the time to reach maximum (peak) serum concentration following a dose. Actual recorded sampling times were considered for the calculations.
dispersion Type
Full Range
groups
  1. description
    Single-agent LAG525 1 mg/kg Q2W
    id
    OG000
    title
    Phase 1: LAG525 1 mg/kg Q2W
  2. description
    Single-agent LAG525 3 mg/kg Q2W
    id
    OG001
    title
    Phase 1: LAG525 3 mg/kg Q2W
  3. description
    Single-agent LAG525 5 mg/kg Q2W
    id
    OG002
    title
    Phase 1: LAG525 5 mg/kg Q2W
  4. description
    Single-agent LAG525 10 mg/kg Q2W
    id
    OG003
    title
    Phase 1: LAG525 10 mg/kg Q2W
  5. description
    Single-agent LAG525 15 mg/kg Q2W
    id
    OG004
    title
    Phase 1: LAG525 15 mg/kg Q2W
  6. description
    Single-agent LAG525 240 mg Q2W
    id
    OG005
    title
    Phase 1: LAG525 240 mg Q2W
  7. description
    Single-agent LAG525 400 mg Q2W
    id
    OG006
    title
    Phase 1: LAG525 400 mg Q2W
  8. description
    Single-agent LAG525 3 mg/kg Q4W
    id
    OG007
    title
    Phase 1: LAG525 3 mg/kg Q4W
  9. description
    Single-agent LAG525 5 mg/kg Q4W
    id
    OG008
    title
    Phase 1: LAG525 5 mg/kg Q4W
  10. description
    Single-agent LAG525 10 mg/kg Q4W
    id
    OG009
    title
    Phase 1: LAG525 10 mg/kg Q4W
  11. description
    Single-agent LAG525 400 mg Q4W
    id
    OG010
    title
    Phase 1: LAG525 400 mg Q4W
  12. description
    Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
    id
    OG011
    title
    Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
param Type
MEDIAN
population Description
All patients in phase 1 who received at least one full or partial dose of LAG525 and who had at least one serum sample providing evaluable PK data.
reporting Status
POSTED
time Frame
pre-infusion, 1, 24, 168, 240 and 336 hours post-infusion, and 504 hours (Q3W regimens only) and 672 hours (Q4W regimens only) post infusion on Cycle 1 Day 1 and Cycle 3 Day 1. The duration of one cycle was 14 days (Q2W), 21 days (Q3W) and 28 days (Q4W).
title
Phase 1: Time to Reach Maximum Serum Concentration (Tmax) of LAG525
type
SECONDARY
unit Of Measure
days

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