Study Evaluating Efficacy and Safety of SAR566658 Treatment in Patients With CA6 Positive Metastatic Triple Negative Breast Cancer

• Status: Terminated
• Trial end date: 2018-09-07
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

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.