Phase 1/2 multiple ascending dose trial of the prostate-specific membrane antigen-targeted antibody drug conjugate MLN2704 in metastatic castration-resistant prostate cancer.

ABSTRACT:

Background

This phase 1/2 study evaluated the dose-limiting toxicity and maximum tolerated dose of MLN2704, a humanized monoclonal antibody MLN591 targeting prostate-specific membrane antigen, linked to the maytansinoid DM1 in patients with progressive metastatic castration-resistant prostate cancer.

Patients and methods

A total of 62 patients received MLN2704 at ascending doses on 4 schedules: weekly (60, 84, 118, and 165mg/m²; 12 patients); every 2 weeks (120, 168, 236, and 330mg/m²; 15 patients); every 3 weeks (330 and 426mg/m²; 18 patients); and on days 1 and 15 of a 6-week schedule (6-week cycle, 330mg/m²; 17 patients). The primary efficacy endpoint was a sustained ≥50% decline from baseline prostate-specific antigen (PSA) wit

SUBMITTER: Milowsky MI 

PROVIDER: S-EPMC5464417 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature