Open-label Phase 2 study evaluating efficacy and safety of SAR566658 treatment in patients with CA6 positive metastatic Triple Negative Breast Cancer - ACT14884

Sanofi-aventis0 个研究点目标入组 5 人开始时间: 待定最近更新: 2024年2月28日

研究概览

暂无简介。

•-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, 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.
•-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 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.

发起方