Phase I/II study of the antibody-drug conjugate glembatumumab vedotin in patients with advanced melanoma.

ABSTRACT:

Purpose

The antibody-drug conjugate glembatumumab vedotin links a fully human immunoglobulin G2 monoclonal antibody against the melanoma-related glycoprotein NMB (gpNMB) to the potent cytotoxin monomethyl auristatin E. This study evaluated the safety and activity of glembatumumab vedotin in patients with advanced melanoma.

Patients and methods

Patients received glembatumumab vedotin every 3 weeks (schedule 1) in a dose escalation and phase II expansion at the maximum-tolerated dose (MTD). Dosing during 2 of 3 weeks (schedule 2) and weekly (schedule 3) was also assessed. The primary end points were safety and pharmacokinetics. The secondary end points included antitumor activity, gpNMB expression, and immunogenicity.

Results

One hundred seventeen patients were treated

SUBMITTER: Ott PA 

PROVIDER: S-EPMC4879709 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature