study evaluating efficacy and safety of sar566658 treatment in patients with ca6 positive metastatic triple negative breast cancer

Conditions: Triple Negative Breast Cancer

Summary: primary objective: to evaluate the tumor objective response rate (orr), according to the response evaluation criteria in solid tumors (recist 1.1) of sar566658 in participants with anti-carbonic anhydrase 6 (ca6)-positive metastatic triple negative breast cancer (tnbc). part 1: to select the sar566658 dose based on orr and safety of 2 dose levels of sar566658. part 2: part 2a: to demonstrate the activity of sar566658 based on orr in participants overexpressing ca6 (membrane intensity of 2+, 3+ in greater than or equal to (\>=) 30% of tumor cells) treated at the selected dose in an expanded cohort, in addition to the participants treated in part 1. - part 2b: to assess the efficacy in participants with metastatic tnbc and mild ca6 expression. secondary objectives: 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.

the duration of the study for 1 participant included a screening period of up to 21 days prior to first study drug administration, 3-week treatment cycle(s) (until 30 days after last sar566658 administration), and a follow-up period. each participant was treated until radiological disease progression, unacceptable toxicity, or participant's refusal of further study treatment.

Eligibility criteria:
inclusion criteria : * measurable metastatic tnbc. * participants with ca6-positive disease. * participants 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. exclusion criteria: * eastern cooperative oncology group (ecog) performance status \>=2. * participant less than 18 years old. * pregnant or breast-feeding women. * participants 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. * participants wearing contact lenses who are not willing to stop wearing them for the duration of the study. * medical conditions requiring concomitant administration of strong cytochrome p450 3a4 (cyp3a4) inhibitors, unless it could be discontinued at least 2 weeks before 1st administration of sar566658. * contraindications to the use of ophthalmic vasoconstrictor and/or corticosteroid. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.