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NCT04995419 · OUTCOME

PK of MMAE in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 15

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
picograms per milliliter (pg/mL)
Interval / dispersion
Standard Deviation
Time frame
Cycle 1 Day 15: pre-dose

What was measured

Ctrough 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/kg12

Reported measurements

Source class 1
Values in picograms per milliliter (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Enfortumab Vedotin 1.25 mg/kg18801680Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1680
        value
        1880
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
description
Ctrough was 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
title
PK of MMAE in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 15
type
PRIMARY
unit Of Measure
picograms per milliliter (pg/mL)

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

Preserved source evidence · Not medical advice