Study Evaluating Efficacy and Safety of SAR566658 Treatment in Patients With CA6 Positive Metastatic Triple Negative Breast Cancer
Condition: Triple Negative Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Intervention: SAR566658 (ACT14884)
Intervention description: Pharmaceutical form:Solution Route of administration: Intravenous
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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.