To select in the first part the SAR566658 dose based on Objective Response Rate (ORR) and safety of 2 dose levels and to demonstrate in the second part the efficacy of the selected dose based on ORR.
- To assess:
- Disease Control Rate (DCR), Duration Of Response (DOR), Progression-Free Survival (PFS), and Time To Progression (TTP)
- The impact of ocular primary prophylaxis on the incidence of keratopathies;
- The potential immunogenicity of SAR566658
- To evaluate the global safety profile
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.
- 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.
|Maximum Eligible Age:||N/A|
|Minimum Eligible Age:||18 Years|