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NCT04995419 · OUTCOME

PK of ADC, TAb, MMAE in Serum: Time to Maximum Concentration (Tmax) at Cycle 1 Day 1

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
MEDIAN
Unit
days
Interval / dispersion
Full Range
Time frame
Cycle 1 Day 1: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)

What was measured

Tmax was derived from the PK blood samples collected.

Analysis population: PKAS population.

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/kg13

Reported measurements

ADC
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin 1.25 mg/kg0.0340Not reported0.02780.0917Not reported
TAb
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin 1.25 mg/kg0.0340Not reported0.02431.89Not reported
MMAE
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin 1.25 mg/kg2.00Not reported1.872.93Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0278
        upper Limit
        0.0917
        value
        0.0340
    title
    ADC
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0243
        upper Limit
        1.89
        value
        0.0340
    title
    TAb
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.87
        upper Limit
        2.93
        value
        2.00
    title
    MMAE
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
Tmax was derived from the PK blood samples collected.
dispersion Type
Full Range
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
MEDIAN
population Description
PKAS population.
reporting Status
POSTED
time Frame
Cycle 1 Day 1: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)
title
PK of ADC, TAb, MMAE in Serum: Time to Maximum Concentration (Tmax) at Cycle 1 Day 1
type
PRIMARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice