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NCT04995419 · OUTCOME

PK of ADC, TAb, MMAE in Serum: Accumulation Ratio of AUC0-7d ( RacAUC0-7d)

A Study to Evaluate Enfortumab Vedotin (ASG-22CE) in Chinese Participants With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Platinum-containing Chemotherapy and Programmed Cell Death Protein-1 ( PD 1) / (Programmed Death Ligand-1 (PD-L1) Inhibitor Therapy · Source last updated 2025-10-07

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

Measure
MEAN
Unit
ratio
Interval / dispersion
Standard Deviation
Time frame
Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)

What was measured

RacAUC0-7d was calculated using AUC0-7d and derived from the PK blood samples collected.

Analysis population: PKAS population with available data were analyzed.

Groups in this outcome

Enfortumab Vedotin 1.25 mg/kg

Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.

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

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin 1.25 mg/kg10

Reported measurements

ADC
Values in ratio · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin 1.25 mg/kg1.200.228Not reportedNot reportedNot reported
TAb
Values in ratio · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin 1.25 mg/kg1.290.208Not reportedNot reportedNot reported
MMAE
Values in ratio · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin 1.25 mg/kg1.320.486Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.228
        value
        1.20
    title
    ADC
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.208
        value
        1.29
    title
    TAb
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.486
        value
        1.32
    title
    MMAE
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
RacAUC0-7d was calculated using AUC0-7d and derived from the PK blood samples collected.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
    id
    OG000
    title
    Enfortumab Vedotin 1.25 mg/kg
param Type
MEAN
population Description
PKAS population with available data were analyzed.
reporting Status
POSTED
time Frame
Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)
title
PK of ADC, TAb, MMAE in Serum: Accumulation Ratio of AUC0-7d ( RacAUC0-7d)
type
PRIMARY
unit Of Measure
ratio

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice