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

Inclusion criteria: Diagnosis of CA6-positive solid tumors as moderate to intense membrane staining of ≥15% of tumor cells for which no standard therapy is available. Exclusion criteria: * Eastem Cooperative Oncology Group performance status ≥2. * Any serious active disease or co-morbid condition, which, in the opinion of the Investigator, may interfere with the safety or the compliance with the study. * Poor bone marrow reserve. * Poor liver and renal function. * Pregnant or breast-feeding woman. * No use of effective birth control methods, when applicable. * No resolution of all specific toxicities (excluding alopecia) related to any prior anti-cancer therapy to Grade ≤1 according to the National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.03 grade scaling. * Wash out period of less than 3 weeks from previous antitumor therapy or any investigational treatment, (and less than 6 weeks in case of prior nitroso-urea and or mitomycin C treatment). Patients will be eligible if hormonotherapy (ie, for breast tumors) is discontinued before first Investigational product administration. * Wash out period of less than 1 week from last palliative dose of radiotherapy. * Patients with respiratory insufficiency defined by a decrease more than 50% compared to theoretical baseline pulmonary volumes and theoretical baseline Diffusing capacity of the Lung for Carbon monoxyde. * Any lung radiotherapy in patient's cancer history. * Patients with previous history or active interstitial lung disease or pulmonary fibrosis. * Patients with abnormal cardiac function defined by a Left Ventricular Ejection Fraction \<50%. * Patients with previous history of acute cardiac failure. * Patients with previous history and/or unresolved corneal disorders. * Known intolerance to infused protein products or maytansinoids. * Patients treated with strong CYP3A inhibitors within 2 weeks prior study drug administration. * For patients to be treated in the midazolam cohort: * Any treatment known to induce CYP3A isoenzymes or to inhibit CYP3A4 activities not allowed within 2 weeks before midazolam administration and up to the end of pharmacokinetic sampling following the last midazolam administration. * Any contra-indications to midazolam, according to the applicable labeling. * Patients older than 60 years. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.