Evaluation of SAR408701 in Japanese Patients With Advanced Malignant Solid Tumors

Exclusion Criteria

• •Patient less than 20 years old.
• •Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥2.
• •Life expectancy \<12 weeks.
• •Known or symptomatic brain metastasis (other than totally resected or previously irradiated and non-progressive/relapsing) or lepto-meningeal carcinomatosis.
• •Female patients of childbearing potential and male patients with female partners of childbearing 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 IMP.
• •Significant concomitant illnesses, including all severe medical conditions which, in the opinion of the Investigator or Sponsor, would impair the patient's participation in the study or interpretation of the results.
• •Prior therapy targeting CEACAM5.
• •Prior maytansinoid treatments (maytansinoid derivative 1 \[DM1\] or maytansinoid derivative 4 \[DM4\] antibody drug conjugates).
• •Previous history and or unresolved corneal disorders.
• •Medical conditions requiring concomitant administration of medications with narrow therapeutic window, metabolized by cytochrome P450 (CYP) and for which a dose reduction cannot be considered.
• •Medical conditions requiring concomitant administration of strong CYP3A inhibitor, unless it can be discontinued at least 2 weeks before first administration of SAR408701.
• •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.