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

NCT ID: NCT02984683

Last Updated: 2021-09-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-23
• Study Completion Date: 2018-09-07

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SAR566658 90 mg/m^2

Participants received SAR566658 90 milligram per square meter (mg/m\^2) as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).

Group Type: EXPERIMENTAL

SAR566658 (ACT14884)

Intervention Type: DRUG

Pharmaceutical form:Solution Route of administration: Intravenous

SAR566658 120 mg/m^2

Participants received SAR566658 120 mg/m\^2 as intravenous infusion on Day 1 and Day 8 of each 21-day treatment cycle (maximum number of cycles received was 3).

Group Type: EXPERIMENTAL

SAR566658 (ACT14884)

Intervention Type: DRUG

Pharmaceutical form:Solution Route of administration: Intravenous

Interventions

SAR566658 (ACT14884)

Pharmaceutical form:Solution Route of administration: Intravenous

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 0560001

Leuven, , Belgium

Investigational Site Number 2030002

Prague, , Czechia

Investigational Site Number 3800003

Genova, , Italy

Investigational Site Number 3800001

Milan, , Italy

Investigational Site Number 3800004

Roma, , Italy

Investigational Site Number 5280001

Maastricht, , Netherlands

Investigational Site Number 5280002

Rotterdam, , Netherlands

Investigational Site Number 7240002

Barcelona, , Spain

Investigational Site Number 7240005

Lleida, , Spain

Investigational Site Number 7240001

Madrid, , Spain

Investigational Site Number 7240006

Madrid, , Spain

Investigational Site Number 7240003

Seville, , Spain

Investigational Site Number 7240004

Valencia, , Spain

Countries

Belgium; Czechia; Italy; Netherlands; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-001962-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1182-7044

Identifier Type: OTHER

Identifier Source: secondary_id

ACT14884

Identifier Type: -

Identifier Source: org_study_id