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Sponsor: Sanofi
Conditions: Triple Negative Breast Cancer
Interventions: SAR566658 (ACT14884)
Countries: Belgium, Czechia, Italy, Netherlands, Spain
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.
Sex: FEMALE
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
- Leuven, Belgium
- Prague, Czechia
- Genova, Italy
- Milan, Italy
- Roma, Italy
- Maastricht, Netherlands
- Rotterdam, Netherlands
- Barcelona, Spain
- Lleida, Spain
- Madrid, Spain
- Madrid, Spain
- Seville, Spain
- Valencia, Spain