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.