A Phase 2 Study of BA3011 Alone and in Combination With PD-1 Inhibitor in Adult Patients With Metastatic Non-small Cell Lung Cancer (NSCLC) Who Had Prior Disease Progression on a PD-1/L-1 Inhibitor, EGFR, or ALK Inhibitor.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 59
- 主要终点
- Confirmed Objective Response Rate (ORR) per RECIST v1.1
研究概览
简要总结
The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in NSCLC
详细描述
This is a multi-center, open-label, Phase 2 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3011, a conditionally active biologic (CAB) AXL-targeted antibody drug conjugate (CAB-AXL-ADC), alone and in combination with PD-1 inhibitor in patients with metastatic non-small cell lung cancer (NSCLC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have measurable disease.
- •Age ≥ 18 years
- •Adequate renal function
- •Adequate liver function
- •Adequate hematological function
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Life expectancy of at least three months.
排除标准
- •Patients must not have clinically significant cardiac disease.
- •Patients must not have known non-controlled CNS metastasis.
- •Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.
- •Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as well as known or suspected allergy or intolerance to any agent given during this study.
- •Patients must not have had major surgery within 4 weeks before first BA3011
- •Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
- •Patients must not be women who are pregnant or breast feeding.
研究组 & 干预措施
CAB-AXL-ADC (BA3011)
CAB-AXL-ADC (BA3011) alone
干预措施: CAB-AXL-ADC (Biological)
CAB-AXL-ADC (BA3011)+PD-1 inhibitor
CAB-AXL-ADC (BA3011) with PD-1 inhibitor
干预措施: CAB-AXL-ADC (Biological)
CAB-AXL-ADC (BA3011)+PD-1 inhibitor
CAB-AXL-ADC (BA3011) with PD-1 inhibitor
干预措施: PD-1 inhibitor (Biological)
结局指标
主要结局
Confirmed Objective Response Rate (ORR) per RECIST v1.1
时间窗: Up to 24 months
Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1
Incidence of Adverse Events (AEs)or Serious Adverse Events (SAEs) as assessed by CTCAE v4.03/v5
时间窗: Up to 24 months
Measured by frequency and severity of adverse events as assessed by CTCAE v4.03/v5
次要结局
- Duration of response (DOR)(Up to 24 months)
- Progression-free survival (PFS)(Up to 24 months)
- Best overall response (BOR)(Up to 24 months)
- Disease control rate (DCR)(Up to 24 months)
- Time to response (TTR)(Up to 24 months)
- Percent change from baseline in target lesion sum of diameters(Up to 24 months)
- Overall survival (OS)(Up to 24 months)