Authors
Johann S De Bono, Nicole Concin, David S Hong, Fiona C Thistlethwaite, Jean-Pascal Machiels, Hendrik-Tobias Arkenau, Ruth Plummer, Robert Hugh Jones, Dorte Nielsen, Kristian Windfeld, Srinivas Ghatta, Brian M Slomovitz, James F Spicer, Jeffrey Yachnin, Joo Ern Ang, Paul Morten Mau-Sørensen, Martin David Forster, Dearbhaile Collins, Emma Dean, Reshma A Rangwala, Ulrik Lassen
Publication date
2019/3/1
Journal
The lancet oncology
Volume
20
Issue
3
Pages
383-393
Publisher
Elsevier
Description
Background
Tisotumab vedotin is a first-in-human antibody–drug conjugate directed against tissue factor, which is expressed across multiple solid tumour types and is associated with poor clinical outcomes. We aimed to establish the safety, tolerability, pharmacokinetic profile, and antitumour activity of tisotumab vedotin in a mixed population of patients with locally advanced or metastatic (or both) solid tumours known to express tissue factor.
Methods
InnovaTV 201 is a phase 1–2, open-label, dose-escalation and dose-expansion study done at 21 centres in the USA and Europe. Patients (aged ≥18 years) had relapsed, advanced, or metastatic cancer of the ovary, cervix, endometrium, bladder, prostate, oesophagus, squamous cell carcinoma of the head and neck or non-small-cell lung cancer; an Eastern Cooperative Oncology Group performance status of 0–1; and had relapsed after or were not eligible to receive …
Total citations
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