Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04995419 · OUTCOME

PK of ADC, TAb, MMAE in Serum: Area Under Concentration-time Curve From 0 to Day 28 (AUC0-28d) 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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Cycle 1 Day 15: pre-dose, EOI, 2 hour, 4 hour post-dose (each cycle = 28 days)

What was measured

AUC0-28d was derived from the PK blood samples collected.

Analysis population: Per protocol, data for AUC0-28d was planned to be calculated using non-compartment analysis (NCA) only if data permits, therefore AUC 0-28d was removed from the planned analysis in SAP.

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/kg0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
AUC0-28d was derived from the PK blood samples collected.
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
population Description
Per protocol, data for AUC0-28d was planned to be calculated using non-compartment analysis (NCA) only if data permits, therefore AUC 0-28d was removed from the planned analysis in SAP.
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: Area Under Concentration-time Curve From 0 to Day 28 (AUC0-28d) at Cycle 1 Day 15
type
PRIMARY

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

Preserved source evidence · Not medical advice