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

The duration of the study for one patient in the dose escalation phase of the study will
include a screening period of up to 3 weeks, a 3-week treatment cycle(s) and a 2-week
treatment cycle(s). The patients may continue treatment until disease progression,
unacceptable toxicity, or willingness to stop, followed by a minimum of 30-day follow-up. If
a patient treated in dose escalation part or in an expansion cohorts, continues to benefit
from the treatment at the time of Clinical Study Report, the patient can continue study
treatment and will continue to undergo all assessments as per the study flowchart. Such
patients will be followed at least until 30 days after the last IMP administration.

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.