Phase I trial of EpCAM-targeting immunotoxin MOC31PE, alone and in combination with cyclosporin.

ABSTRACT:

Background

A phase I trial was performed to determine the maximum tolerated dose (MTD), safety, pharmacokinetics and immunogenicity of the anti-EpCAM immunotoxin (IT) MOC31PE in cancer patients. An important part of the study was to investigate whether the addition of Sandimmune (cyclosporin, CsA) suppressed the development of anti-IT antibodies.

Methods

Patients with EpCAM-positive metastatic disease were eligible for treatment with intravenous MOC31PE using a modified Fibonacci dose escalation sequence. Maximum tolerated dose was first established without, then with intravenously administered CsA.

Results

Sixty-three patients were treated with MOC31PE in doses ranging from 0.5 to 8 μg kg(-1). Maximum tolerated dose was 8 μg kg(-1) for MOC31PE alone, and 6.5 μg kg(-1

SUBMITTER: Andersson Y 

PROVIDER: S-EPMC4705890 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature