NCT04995419 · OUTCOME

PK of ADC, TAb, MMAE in Plasma: Accumulation Ratio of Cmax (RacCmax)

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

Accumulation ratio is the ratio of Cmax after the dosing interval (Cycle 1 Day 15) divided by Cmax after the first dosing interval (Cycle 1 Day 1).

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

Group	Source count
Enfortumab Vedotin 1.25 mg/kg	10

Reported measurements

ADC

Values in ratio · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin 1.25 mg/kg	1.03	0.150	Not reported	Not reported	Not reported

TAb

Values in ratio · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin 1.25 mg/kg	1.13	0.137	Not reported	Not reported	Not reported

MMAE

Values in ratio · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Enfortumab Vedotin 1.25 mg/kg	1.28	0.499	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.150
value
1.03
title
ADC
categories
measurements
group Id
OG000
spread
0.137
value
1.13
title
TAb
categories
measurements
group Id
OG000
spread
0.499
value
1.28
title
MMAE

denoms

counts
group Id
OG000
value
10
units
Participants

description

Accumulation ratio is the ratio of Cmax after the dosing interval (Cycle 1 Day 15) divided by Cmax after the first dosing interval (Cycle 1 Day 1).

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 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 Plasma: Accumulation Ratio of Cmax (RacCmax)

type

PRIMARY

unit Of Measure

ratio

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Preserved source evidence · Not medical advice