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.