NCT04995419 · OUTCOME

PK of ADC , TAb in Serum: Trough Concentration (Ctrough) 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: MEAN
Unit: ug/mL
Interval / dispersion: Standard Deviation
Time frame: Cycle 1 Day 1: pre-dose

What was measured

As per planned analysis, if more than 50% of PK concentrations were below the limit of quantification (i.e 0) at a given time point, standard deviation was not reported.

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

Group	Source count
Enfortumab Vedotin 1.25 mg/kg	13

Reported measurements

ADC

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin 1.25 mg/kg	0	NA	Not reported	Not reported	Standard Deviation was not reported in summary statistics because more than 50% of ADC concentrations at pre-dose were 0.

TAb

Values in ug/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin 1.25 mg/kg	0	NA	Not reported	Not reported	Standard Deviation was not reported in summary statistics because more than 50% of TAb concentrations at pre-dose were 0.

Complete source fields

classes

categories
measurements
comment
Standard Deviation was not reported in summary statistics because more than 50% of ADC concentrations at pre-dose were 0.
group Id
OG000
spread
NA
value
0
title
ADC
categories
measurements
comment
Standard Deviation was not reported in summary statistics because more than 50% of TAb concentrations at pre-dose were 0.
group Id
OG000
spread
NA
value
0
title
TAb

denoms

counts
group Id
OG000
value
13
units
Participants

description

As per planned analysis, if more than 50% of PK concentrations were below the limit of quantification (i.e 0) at a given time point, standard deviation was not reported.

dispersion Type

Standard Deviation

groups

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.

reporting Status

POSTED

time Frame

Cycle 1 Day 1: pre-dose

title

PK of ADC , TAb in Serum: Trough Concentration (Ctrough) at Cycle 1 Day 1

type

PRIMARY

unit Of Measure

ug/mL

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

Preserved source evidence · Not medical advice