Open-label Phase 2 Study Evaluating Efficacy and Safety of SAR566658 Treatment in Patients With CA6 Positive Metastatic Triple Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 23
- 试验地点
- 13
- 主要终点
- Number of Participants With Investigational Medicinal Product (IMP)-Related Predefined Safety Criteria Findings
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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).
干预措施: SAR566658 (ACT14884) (Drug)
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).
干预措施: SAR566658 (ACT14884) (Drug)
结局指标
主要结局
Number of Participants With Investigational Medicinal Product (IMP)-Related Predefined Safety Criteria Findings
时间窗: Up to Cycle 2 (each cycle of 21 days)
Predefined safety criteria was defined as occurrence of following IMP-related treatment-emergent adverse event (TEAE) (based on National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v4.03): Grade greater than or equal to (\>=) 3 TEAE from the System Organ Class (SOC) of eye disorders, Grade \>=3 peripheral neuropathy (Preferred Term), Grade \>=4 TEAE. Per NCI-CTCAE v4.03, Adverse Events (AE) were graded as follows: Grade 1: Mild; asymptomatic/mild symptoms; Grade 2: Moderate; minimal, local or non-invasive intervention indicated; Grade 3: Severe or medically significant; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; Grade 5: Death related to AE.
Percentage of Participants With Objective Response
时间窗: Baseline, every 6 weeks until radiological disease progression or study cut-off, whichever comes first (maximum number of cycles was 3, each cycle 21 days)
Objective Response in participants was defined as the participants with complete response (CR) and partial response (PR) as best response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). As per RECIST 1.1, CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
次要结局
- Percentage of Participants With Disease Control(Baseline, every 6 weeks until radiological disease progression or study cut-off, whichever comes first (maximum number of cycles was 3, each cycle 21 days))
- Duration of Response (DOR)(Baseline, every 6 weeks until radiological disease progression or study cut-off, whichever comes first (maximum number of cycles was 3, each cycle 21 days))
- Progression Free Survival (PFS)(Baseline, every 6 weeks until radiological disease progression or study cut-off, whichever comes first (maximum number of cycles was 3, each cycle 21 days))
- Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events (SAE)(Up to 30 days after last drug administration (maximum number of cycles was 3, each cycle 21 days))
- Time to Tumor Progression (TTP)(Baseline, every 6 weeks until radiological disease progression or study cut-off, whichever comes first (maximum number of cycles was 3, each cycle 21 days))
- Number of Participants With Keratopathies (Corneal Toxicity)(Up to 30 days after last drug administration (maximum number of cycles was 3, each cycle 21 days))
- Number of Participants With Positive Anti-SAR566658 Antibodies Response(Up to 3 treatment cycles, each cycle 21 days)