First-in-human trial exploring safety, antitumor activity, and pharmacokinetics of Sym013, a recombinant pan-HER antibody mixture, in advanced epithelial malignancies

Conclusion.  During the conduct of the study, management of frequent infusion-related reactions, skin toxicities, and mucosal disorders, which are indicative of HER inhibition, necessitated multiple protocol amendments. The investigators, in concert with the Sponsor, agreed that achieving a tolerated regimen w ith acceptable target saturation was unlikely.Trial registry:www.clinicaltrials.gov; NCT02906670 (September 20, 2016).
Source: Investigational New Drugs - Category: Drugs & Pharmacology Source Type: research