A Study of SAR428926 in Patients With Advanced Solid Tumors

Inclusion criteria :

• Patients with advanced solid tumor with no standard alternative treatment.
• Availability of archived tumor tissue for SAR428926 targeted antigen testing.
• For participants in the Escalation Phase: human epidermal growth factor receptor 2 (HER2) negative breast cancer (BC), gastric cancer, colorectal cancer (CRC), ovarian cancer, prostate cancer and non small-cell lung cancer (NSCLC).
• For participants in the Expansion Phase: patients with TNBC, prostate cancer, CRC, ovarian cancer or NSCLC and positive SAR428926 targeted antigen.
• At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and one lesion amenable to biopsy in expansion cohort only (except for NSCLC patients).

Exclusion criteria:

• Age less than 18 years old.
• Eastern Cooperative Oncology Group (ECOG) performance status more than 1.
• New or progressing brain metastases.
• Concurrent treatment with any other anticancer therapy or inadequate wash-out period for prior anticancer therapies, including other experimental anticancer treatment, before first administration of SAR428926, or non resolution of toxicities induced by these anticancer therapies.
• Women of reproductive potential and male subjects with female partners of childbearing potential who are not willing to avoid pregnancy.
• Pregnancy or breast feeding.
• Prior maytansinoid treatments (DM1 or DM4 antibody drug conjugates [ADCs]).
• Unwillingness and inability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
• Significant concomitant illness, including psychiatric condition that, in the opinion of the Investigator or Sponsor, would adversely affect the patient's participation in the study.
• Any surgery within the preceding 3 weeks.
• Known human immunodeficiency virus (HIV) infection or active hepatitis B or C viral infection.
• Poor bone marrow reserve.
• Poor kidney and liver function.
• Previous history of chronic corneal diseases (even if asymptomatic) or unresolved acute non-recurrent corneal conditions. Patients wearing contact lenses who are not willing to stop wearing them for the duration of the study.
• Unresolved signs and symptoms of peripheral neuropathy; Grade 1 is acceptable.
• Abnormal cardiac function defined by a left ventricular ejection fraction (LVEF) <50%.
• Known intolerance to infused protein products including other monoclonal antibodies and ADCs.
• Medical conditions requiring concomitant administration of medications with narrow therapeutic window, metabolized by CYPs and which a dose reduction cannot be considered.
• Medical conditions requiring concomitant administration of strong CYP3A inhibitors, unless it can be discontinued at least two weeks before first administration of SAR428926.
• Other prior neoplasm.
• 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.