ArticleCPT: pharmacometrics & systems pharmacology2025
PBPK Modeling to Predict Clinical Drug-Drug Interaction and Impact of Hepatic Impairment for an ADC With the Payload Auristatin F-Hydroxypropylamide.
Article in CPT: pharmacometrics & systems pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
- Applications of Pharmacometrics in Antibody-Drug Conjugate Development.Pharmaceutics · 2026Review
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Upifitamab rilsodotin-an antibody drug conjugate (ADC)-comprises a NaPi2b-targeted antibody conjugated to an auristatin-based payload (auristatin F-hydroxypropylamide [AF-HPA]). AF-HPA is metabolized by cytochrome P450 3A4 (CYP3A4) and, to a lower extent, by CYP3A5 and demonstrates both reversible and time-dependent inhibition of CYP3A4. AF-HPA is also a P-glycoprotein (P-gp) substrate. A PBPK model was developed using a mixed "bottom-up" and "top-down" modeling approach with a combination of in vitro, nonclinical, and clinical ADME/PK data. The model recapitulated the clinical PK of conjugated and unconjugated AF-HPA. Simulations were used to predict the potential of unconjugated AF-HPA to be a victim or perpetrator of clinical drug-drug interactions (DDI) and predict the impact of hepatic impairment on the exposure to unconjugated AF-HPA. Simulations suggested negligible potential for clinical DDI between unconjugated AF-HPA and CYP3A substrates. Simulations also showed ~30% increase in unconjugated AF-HPA exposure following an IV dose of 36 mg/m
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