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NCT04995419 · OUTCOME

PK of ADC, TAb, MMAE in Serum: Terminal Elimination Half-life (t1/2)

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 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)

What was measured

t1/2 was 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

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin 1.25 mg/kg10
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin 1.25 mg/kg2.81Not reported2.283.70Not reported
TAb

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin 1.25 mg/kg10
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin 1.25 mg/kg3.82Not reported3.115.49Not reported
MMAE

Analysis denominator · Participants

GroupSource count
Enfortumab Vedotin 1.25 mg/kg9
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin 1.25 mg/kg3.12Not reported2.833.82Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.28
        upper Limit
        3.70
        value
        2.81
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      units
      Participants
    title
    ADC
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.11
        upper Limit
        5.49
        value
        3.82
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      units
      Participants
    title
    TAb
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.83
        upper Limit
        3.82
        value
        3.12
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    MMAE
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
t1/2 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 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: Terminal Elimination Half-life (t1/2)
type
PRIMARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice