First in Man Study of SAR566658 Administered in Patients With CA6-Positive and Refractory Solid Tumor
Status:
Completed
Trial end date:
2017-04-07
Target enrollment:
Participant gender:
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