First in Man Study of SAR566658 Administered in Patients With CA6-Positive and Refractory Solid Tumor

Summary

Primary Objective: To determine the maximum tolerated dose (MTD) of SAR566658 Secondary Objectives: * To characterize the safety profile of SAR566658 * To evaluate the pharmacokinetic profile of SAR566658 * To assess the potential immunogenicity of SAR566658 * To assess preliminary antitumor activity * To assess the effect of SAR566658 at recommended dose on CYP3A enzyme activity using midazolam * To assess safety in the alternative schedules of SAR566658 administration

Timeline

Start

2010-09-08

Primary completion

2017-04-07

Completion

2017-04-07

Drugs

Indications