Enfortumab vedotin exposure and weight-band dosing

40 kg — approved, 1.25 mg/kg tier

Fixed-input intact-ADC trajectory under the declared monotherapy schedule.

Readouts

Central concentration · mg/L

Central concentration over the selected simulation window.

AUC first · mg*h/L

AUC first over the selected simulation window.

AUC late · mg*h/L

AUC late over the selected simulation window.

Accounted amount · mg

Accounted amount over the selected simulation window.

Study purpose

• How do the model's key biological readouts change under 40 kg — approved, 1.25 mg/kg tier?

Assumptions

• Conditional fixed-input intact-ADC exposure, with individual deviations fixed to zero in the supplied contexts.
• The 500-person source demographic sample and original random draws are unavailable; reference trajectories are not population geometric means, CVs or equivalence results.
• All administrations use the monotherapy schedule: days 1, 8 and 15 of each 28-day cycle, represented at hours 0, 168 and 336 within each cycle; 30-minute infusions.
• The first-cycle observer stops at 672 h; the late observer starts at 6048 h and is read at the fixed 6720 h endpoint. It does not stop automatically if the horizon is extended.
• The late window corresponds to days 252–280; it is not initialized at an exact periodic steady state.
• Weight-band probes use interior weights because the publication does not determine every shared boundary inclusion.
• The 110 kg probes use the explicitly reported initial 1.25 mg/kg cap of 125 mg; no reduced-tier high-weight cap is inferred.
• Dose amounts and body weight are frozen together; changing weight requires rebuilding both PK inputs and the corresponding administration amounts.
• No unconjugated payload, antitumor response, toxicity or clinical dosing recommendation is calculated.