NCT02984683

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

Open-label Phase 2 Study Evaluating Efficacy and Safety of SAR566658 Treatment in Patients With CA6 Positive Metastatic Triple Negative Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Sanofi · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	SAR566658 (ACT14884)	Pharmaceutical form:Solution Route of administration: Intravenous

Timeline

• Start date: 2017-03-23
• Primary completion: 2018-09-07
• Completion: 2018-09-07
• First posted: 2016-12-07
• Last updated: 2021-09-08
• Results posted: 2021-09-08

Locations

13 sites across 5 countries: Belgium, Czechia, Italy, Netherlands, Spain

Regulatory

• FDA-regulated drug study