The dose-escalation Phase I trial will evaluate the safety profile, pharmacokinetics and antitumour activity of brentuximab vedotin when administered sequentially or in combination with multi-agent front-line chemotherapy regimens.
The study is expected to enroll 60 patients across multiple centres in the US and Europe.
Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, which is highly expressed in ALCL, and is being jointly developed by Seattle Genetics and Millennium.
Under the terms of collaboration agreement, Seattle Genetics will have rights to commercialise brentuximab vedotin in the US and Canada, while Millennium will have commercialisation rights in the rest of the world.