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NCT03881488 · OUTCOME

Area Under the Serum Concentrations of CTX-471 Versus Time Curve (AUC)

Study of CTX-471 as a Monotherapy or in Combination With Pembrolizumab in Patients Post PD-1/PD-L1 Inhibitors in Metastatic or Locally Advanced Malignancies · Source last updated 2026-10-09

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

Measure
GEOMETRIC_MEAN
Unit
h∙ng/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Monotherapy arms: before Week 1 dose; 1, 6, 24 hours and 2 weeks after Week 1 dose; before Week 9 dose; 1, 6, 24 hours after Week 9 dose. Combination therapy arms: before Week 1 dose; 1, 6, 24 hours and 2 weeks after Week 1 dose.

What was measured

AUC(0-24) = AUC from time 0 to 24 hours (1 day); AUC(0-336) = AUC from time 0 to 336 hours (14 days). Calculated from plasma concentrations measured from samples collected at the time points below.

Analysis population: Pharmacokinetic Analysis Set: all patients who received CTX-471 (and pembrolizumab in combination arms) and had at least 1 post-treatment measurement and no protocol deviations or events affecting the validity of the results

Groups in this outcome

CTX-471 Monotherapy 0.1 mg/kg

0.1 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks

CTX-471 Monotherapy 0.3 mg/kg

0.3 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks

CTX-471 Monotherapy 0.6 mg/kg

0.6 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks

CTX-471 Monotherapy 1.2 mg/kg

1.2 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks

CTX-471 Combination 0.1 mg/kg

0.1 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks + 400 mg of pembrolizumab by IV infusion over 30 minutes every 6 weeks

CTX-471 Combination 0.3 mg/kg

0.3 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks + 400 mg of pembrolizumab by IV infusion over 30 minutes every 6 weeks

CTX-471 Combination 0.6 mg/kg

0.6 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks + 400 mg of pembrolizumab by IV infusion over 30 minutes every 6 weeks

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

Analysis denominator · Participants

GroupSource count
CTX-471 Monotherapy 0.1 mg/kg3
CTX-471 Monotherapy 0.3 mg/kg13
CTX-471 Monotherapy 0.6 mg/kg13
CTX-471 Monotherapy 1.2 mg/kg5
CTX-471 Combination 0.1 mg/kg2
CTX-471 Combination 0.3 mg/kg3
CTX-471 Combination 0.6 mg/kg4

Reported measurements

Week 1 AUC(0-24)

Analysis denominator · Participants

GroupSource count
CTX-471 Monotherapy 0.1 mg/kg3
CTX-471 Monotherapy 0.3 mg/kg13
CTX-471 Monotherapy 0.6 mg/kg13
CTX-471 Monotherapy 1.2 mg/kg5
CTX-471 Combination 0.1 mg/kg2
CTX-471 Combination 0.3 mg/kg3
CTX-471 Combination 0.6 mg/kg4
Values in h∙ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
CTX-471 Monotherapy 0.1 mg/kg33849.438.4Not reportedNot reportedNot reported
CTX-471 Monotherapy 0.3 mg/kg123698.850.5Not reportedNot reportedNot reported
CTX-471 Monotherapy 0.6 mg/kg208795.638.7Not reportedNot reportedNot reported
CTX-471 Monotherapy 1.2 mg/kg498570.532.5Not reportedNot reportedNot reported
CTX-471 Combination 0.1 mg/kgNANANot reportedNot reportedInsufficient data to calculate geometric mean and geometric coefficient of variation
CTX-471 Combination 0.3 mg/kg161090.86.8Not reportedNot reportedNot reported
CTX-471 Combination 0.6 mg/kg149520.7344.0Not reportedNot reportedNot reported
Week 1 AUC(0-336)

Analysis denominator · Participants

GroupSource count
CTX-471 Monotherapy 0.1 mg/kg3
CTX-471 Monotherapy 0.3 mg/kg13
CTX-471 Monotherapy 0.6 mg/kg13
CTX-471 Monotherapy 1.2 mg/kg5
CTX-471 Combination 0.1 mg/kg2
CTX-471 Combination 0.3 mg/kg3
CTX-471 Combination 0.6 mg/kg4
Values in h∙ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
CTX-471 Monotherapy 0.1 mg/kg223886.841.7Not reportedNot reportedNot reported
CTX-471 Monotherapy 0.3 mg/kg818109.945.7Not reportedNot reportedNot reported
CTX-471 Monotherapy 0.6 mg/kg1579811.427.5Not reportedNot reportedNot reported
CTX-471 Monotherapy 1.2 mg/kg3500751.437.5Not reportedNot reportedNot reported
CTX-471 Combination 0.1 mg/kgNANANot reportedNot reportedInsufficient data to calculate geometric mean and geometric coefficient of variation
CTX-471 Combination 0.3 mg/kg1123811.424.3Not reportedNot reportedNot reported
CTX-471 Combination 0.6 mg/kg1034157.2357.5Not reportedNot reportedNot reported
Week 9 (steady state) AUC(0-24)

Analysis denominator · Participants

GroupSource count
CTX-471 Monotherapy 0.1 mg/kg1
CTX-471 Monotherapy 0.3 mg/kg4
CTX-471 Monotherapy 0.6 mg/kg3
CTX-471 Monotherapy 1.2 mg/kg3
CTX-471 Combination 0.1 mg/kg0
CTX-471 Combination 0.3 mg/kg0
CTX-471 Combination 0.6 mg/kg0
Values in h∙ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
CTX-471 Monotherapy 0.1 mg/kg66000.0NANot reportedNot reportedA geometric mean coefficient of variation cannot be calculated for data from only 1 participant.
CTX-471 Monotherapy 0.3 mg/kg184610.221.9Not reportedNot reportedNot reported
CTX-471 Monotherapy 0.6 mg/kg224875.816.7Not reportedNot reportedNot reported
CTX-471 Monotherapy 1.2 mg/kg466764.055.4Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        38.4
        value
        33849.4
      2. group Id
        OG001
        spread
        50.5
        value
        123698.8
      3. group Id
        OG002
        spread
        38.7
        value
        208795.6
      4. group Id
        OG003
        spread
        32.5
        value
        498570.5
      5. comment
        Insufficient data to calculate geometric mean and geometric coefficient of variation
        group Id
        OG004
        spread
        NA
        value
        NA
      6. group Id
        OG005
        spread
        6.8
        value
        161090.8
      7. group Id
        OG006
        spread
        344.0
        value
        149520.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        5
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        3
      7. group Id
        OG006
        value
        4
      units
      Participants
    title
    Week 1 AUC(0-24)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        41.7
        value
        223886.8
      2. group Id
        OG001
        spread
        45.7
        value
        818109.9
      3. group Id
        OG002
        spread
        27.5
        value
        1579811.4
      4. group Id
        OG003
        spread
        37.5
        value
        3500751.4
      5. comment
        Insufficient data to calculate geometric mean and geometric coefficient of variation
        group Id
        OG004
        spread
        NA
        value
        NA
      6. group Id
        OG005
        spread
        24.3
        value
        1123811.4
      7. group Id
        OG006
        spread
        357.5
        value
        1034157.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        5
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        3
      7. group Id
        OG006
        value
        4
      units
      Participants
    title
    Week 1 AUC(0-336)
  3. categories
    1. measurements
      1. comment
        A geometric mean coefficient of variation cannot be calculated for data from only 1 participant.
        group Id
        OG000
        spread
        NA
        value
        66000.0
      2. group Id
        OG001
        spread
        21.9
        value
        184610.2
      3. group Id
        OG002
        spread
        16.7
        value
        224875.8
      4. group Id
        OG003
        spread
        55.4
        value
        466764.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      units
      Participants
    title
    Week 9 (steady state) AUC(0-24)
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      13
    3. group Id
      OG002
      value
      13
    4. group Id
      OG003
      value
      5
    5. group Id
      OG004
      value
      2
    6. group Id
      OG005
      value
      3
    7. group Id
      OG006
      value
      4
    units
    Participants
description
AUC(0-24) = AUC from time 0 to 24 hours (1 day); AUC(0-336) = AUC from time 0 to 336 hours (14 days). Calculated from plasma concentrations measured from samples collected at the time points below.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    0.1 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks
    id
    OG000
    title
    CTX-471 Monotherapy 0.1 mg/kg
  2. description
    0.3 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks
    id
    OG001
    title
    CTX-471 Monotherapy 0.3 mg/kg
  3. description
    0.6 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks
    id
    OG002
    title
    CTX-471 Monotherapy 0.6 mg/kg
  4. description
    1.2 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks
    id
    OG003
    title
    CTX-471 Monotherapy 1.2 mg/kg
  5. description
    0.1 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks + 400 mg of pembrolizumab by IV infusion over 30 minutes every 6 weeks
    id
    OG004
    title
    CTX-471 Combination 0.1 mg/kg
  6. description
    0.3 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks + 400 mg of pembrolizumab by IV infusion over 30 minutes every 6 weeks
    id
    OG005
    title
    CTX-471 Combination 0.3 mg/kg
  7. description
    0.6 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks + 400 mg of pembrolizumab by IV infusion over 30 minutes every 6 weeks
    id
    OG006
    title
    CTX-471 Combination 0.6 mg/kg
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic Analysis Set: all patients who received CTX-471 (and pembrolizumab in combination arms) and had at least 1 post-treatment measurement and no protocol deviations or events affecting the validity of the results
reporting Status
POSTED
time Frame
Monotherapy arms: before Week 1 dose; 1, 6, 24 hours and 2 weeks after Week 1 dose; before Week 9 dose; 1, 6, 24 hours after Week 9 dose. Combination therapy arms: before Week 1 dose; 1, 6, 24 hours and 2 weeks after Week 1 dose.
title
Area Under the Serum Concentrations of CTX-471 Versus Time Curve (AUC)
type
SECONDARY
unit Of Measure
h∙ng/mL

Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0

Preserved source evidence · Not medical advice