Study Evaluating Efficacy and Safety of SAR566658 Treatment in Patients With CA6 Positive Metastatic Triple Negative Breast Cancer

The duration of the study for 1 patient will include a screening period of up to 21 days
prior to first study drug administration, 3-week treatment cycle(s) (until 30 days after last
SAR566658 administration), and a follow-up period. Each patient will be treated until
radiological disease progression, unacceptable toxicity, or patient's refusal of further
study treatment.

Inclusion criteria :

- Measurable Metastatic triple negative breast cancer (TNBC).

- Patients with CA6-positive disease.

- Patients received at least 1 prior chemotherapy regimen but no more than 3 for
advanced/metastatic disease.

- Prior anticancer therapy must have contained anthracycline (eg, doxorubicin), if not
contraindicated, and a taxane (eg, docetaxel, paclitaxel) in an adjuvant/neo-adjuvant
or metastatic setting.

Exclusion criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status ≥2.

- Patient less than 18 years old.

- Pregnant or breast-feeding women.

- Patients with reproductive potential who do not agree to use accepted and effective
method of contraception during the study treatment period and for 6 months following
discontinuation of study drug.

- Wash out period of less than 3 weeks or 5 half-lives from previous antitumor
chemotherapy, immunotherapy, or any investigational treatment.

- History of brain metastasis (other than totally resected or previously irradiated and
nonprogressive/relapsed), spinal cord compression or carcinomatous meningitis, or new
evidence of brain leptomeningeal disease.

- Prior treatment with eribulin as last prior therapy or prior maytansinoid treatments
(DM1 or DM4 antibody-drug conjugates [ADCs]).

- Known intolerance to infused protein products including other monoclonal antibodies
and ADCs.

- Poor bone marrow reserve and/or poor organ function.

- Symptomatic peripheral neuropathy Grade ≥2.

- Previous history of chronic corneal diseases (even if asymptomatic) or unresolved
acute nonrecurrent corneal conditions.

- Patients wearing contact lenses who are not willing to stop wearing them for the
duration of the study.

- Medical conditions requiring concomitant administration of strong CYP3A4 inhibitors,
unless it can be discontinued at least 2 weeks before 1st administration of SAR566658.

- Contraindications to the use of ophthalmic vasoconstrictor and/or corticosteroid.

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.