Evaluation of SAR408701 in Patients With Advanced Solid Tumors

Exclusion Criteria

• •Aged less than 18 years.
• •Eastern Cooperative Oncology Group (ECOG) performance status more than 1.
• •New or progressing brain involvement.
• •Concurrent treatment with any other anticancer therapy or inadequate wash-out period for prior anticancer therapies before first administration of SAR408701, or non-resolution of toxicities induced by these anticancer therapies.
• •Female or male patients with reproductive potential who do not agree to use an accepted effective method of contraception during the study treatment period and for at least 3 months following completion of study treatment.
• •Pregnancy or breast-feeding.
• •Participation to any clinical research study evaluating another investigational drug or therapy within 3 weeks of initiation of study regimen.
• •Prior therapy targeting CEACAM5.
• •Prior maytansinoid treatments (DM1 or DM4 antibody drug conjugates).
• •Poor bone marrow reserve resulting in low blood cell counts.
• •Poor kidney and liver functions.
• •Any of the following within 6 months prior to study enrolment: infectious or inflammatory bowel disease, diverticulitis, gastrointestinal perforation, intestinal obstruction, and gastrointestinal hemorrhage. Patients with malabsorption syndrome are excluded.
• •Previous history and or unresolved corneal disorders. The use of contact lenses is not permitted.
• •Unresolved signs and symptoms of neuropathy; Grade 1 is acceptable if prior neurotoxic drugs such as cisplatin or taxanes.
• •Abnormal cardiac function defined by a left ventricular ejection fraction (LVEF) of \<50%.
• •Cardiac conduction defects, or any other clinically significant arrhythmias.
• •Known intolerance to infused protein products.
• •Medical conditions requiring concomitant administration of medications with narrow therapeutic window, metabolized by cytochrome P450 (CYPs) enzymes 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 1st administration of SAR408701.
• •Contraindications to the use of ophthalmic vasoconstrictor and/or corticosteroid as per package insert of each drug, including the following: increase intraocular pressure, prior or current glaucoma, narrow-angle glaucoma, ongoing eye infection, uncontrolled hypertension, known/suspected allergy to constituents of the preparation (such as sodium bisulfite).
• •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.