Study of the Safety of VB6-845 in Patients With Advanced Solid Tumours of Epithelial Origin

The primary study objective of this Phase 1 trial was to determine the maximum tolerated dose (MTD) of VB6-845 and evaluate the safety and tolerability of VB6-845 when administered as a monotherapy intravenous (IV) infusion (over 3 hours), once weekly in 4-week cycles, to subjects with EpCAM positive advanced solid tumours of epithelial origin.

Secondary objectives included evaluating the pharmacokinetic profile and immunogenicity of VB6-845 and assessing exploratory efficacy of VB6-845.

Dose cohorts of 3-6 subjects with EpCAM positive advanced solid tumours of epithelial origin are to be entered into the study. The starting dose is defined as 1.00 mg/kg, which is 1/10 of the no observed adverse effect level (NOAEL) reached in preclinical studies. Doses are to be escalated according to the modified Fibonacci design until 2 out of 3 or 2 out of 6 subjects experienced a Dose Limiting Toxicity (DLT). The MTD is to be reached when \<2 out of 6 subjects experienced a DLT. An additional 12 subjects are to be enrolled at the MTD for further characterization of VB6-845 at that level.

Regardless of dose cohort, subjects are to continue to receive treatment until an unacceptable toxicity occurred, all lesions completely disappeared or disease progression is determined.