A Phase 1/2 Dose Escalation and Dose Expansion Study of Mecbotamab Vedotin (BA3011) Alone and in Combination With Nivolumab in Adult and Adolescent Patients 12 Years and Older With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 40
- 主要终点
- Phase 1 and 2: Safety Profile
研究概览
简要总结
The objective of this study is to assess the safety and efficacy of mecbotamab vedotin (BA3011) in solid tumors.
详细描述
This is a multi-center, open-label, Phase 1/2 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of mecbotamab vedotin (BA3011), a conditionally active biologic (CAB) AXL-targeted antibody drug conjugate (CAB-AXL-ADC) in patients with advanced solid tumors.
Phase 1 of this study will consist of a dose escalation phase (enrollment complete as of Oct 2019) and a dose expansion phase (enrollment complete as of Jan 2024).
Phase 2 will consist of two parts. Part 1 is designed to evaluate mecbotamab vedotin alone and with nivolumab in patients with various types of advanced sarcomas (enrollment complete as of Jan 2024). Part 2 will evaluate the safety and efficacy of mecbotamab vedotin in patients with undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS).
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have measurable disease.
- •Age ≥ 12 years (Phase 2)
- •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 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 administration.
- •Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.
- •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
BA3011
Phase 1: All patients will receive BA3011, CAB-AXL-ADC.
Phase 2: All patients will receive either BA3011 alone or in combination with PD-1 inhibitor.
干预措施: CAB-AXL-ADC (Biological)
Combination Therapy
Phase 2: BA3011 in combination with PD-1 inhibitor.
干预措施: CAB-AXL-ADC (Biological)
Combination Therapy
Phase 2: BA3011 in combination with PD-1 inhibitor.
干预措施: PD-1 inhibitor (Biological)
结局指标
主要结局
Phase 1 and 2: Safety Profile
时间窗: Up to 24 months
Frequency and severity of AEs and/or SAEs, and changes from baseline in laboratory parameters and vital signs
Phase 2: Confirmed overall 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
Phase 1: Safety Profile
时间窗: Up to 24 months
Assess maximum tolerated dose as defined in the protocol
次要结局
- Phase 1: Overall response rate (ORR)(Up to 24 months)
- Phase 1 and 2: Best overall response (BOR)(Up to 24 months)
- Phase 1: Immunogenicity(Up to 24 months)
- Phase 1 and 2: Time to response (TTR)(Up to 24 months)
- Phase 1 and 2: Overall survival (OS)(Up to 24 months)
- Phase 1 and 2: Tumor size(Up to 24 months)
- Phase 1: Pharmacokinetics(Up to 24 months)
- Phase 1 and 2: Duration of response (DOR)(Up to 24 months)
- Phase 1 and 2: Disease control rate (DCR)(Up to 24 months)
- Phase 1 and 2: Progression-free survival (PFS)(Up to 24 months)