A Phase 1/2 Safety and Efficacy Dose Escalation / Dose Expansion Study of a CAB-ROR2-ADC, Alone and in Combination With a PD-1 Inhibitor, in Patients With Advanced Solid Tumors (Ph1) and Melanoma and NSCLC Patients (Ph2)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 58
- 主要终点
- Phase 1: Safety Profile
研究概览
简要总结
The objective of this study is to assess safety and efficacy of CAB-ROR2-ADC 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 BA3021, a conditionally active biologic (CAB) ROR2-targeted antibody drug conjugate (CAB-ROR2-ADC) BA3021 in patients with advanced solid tumors.
This study will consist of a dose escalation phase and a dose expansion phase with BA3021 in Phase 1. Phase 2 will study BA3021 alone or in combination with a PD-1 inhibitor.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor and have failed all available standard of care (SoC) therapy and for whom no curative therapy is available or who are not eligible, intolerant to or refuse standard therapy.
- •Patients must have measurable disease.
- •For the dose expansion phase: Patients with locally advanced unresectable or metastatic, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC) and soft tissue sarcoma (STS)
- •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 a history of ≥ Grade 3 allergic reactions to mAb therapy as wellas 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 BA3021 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
Monotherapy - CAB-ROR2-ADC (BA3021) alone
BA3021 alone Q2W dosing regimen
干预措施: CAB-ROR2-ADC (Biological)
Combination Therapy
CAB-ROR2-ADC (BA3021) with PD-1 inhibitor
干预措施: CAB-ROR2-ADC (Biological)
Combination Therapy
CAB-ROR2-ADC (BA3021) with PD-1 inhibitor
干预措施: PD-1 inhibitor (Biological)
结局指标
主要结局
Phase 1: Safety Profile
时间窗: Up to 24 months
Assess maximum tolerated dose as defined in the protocol
Phase 1 and 2: Safety Profile
时间窗: Up to 24 months
Frequency and severity of AEs and/or SAEs
Phase 2: Confirmed Objective Response Rate (ORR)
时间窗: Up to 24 months
Proportion of patients who achieve a confirmed CR or PR
次要结局
- Phase 1 and 2: Overall survival (OS)(Up to 24 months)
- Phase 1 and 2: Progression-free survival (PFS)(Up to 24 months)
- Phase 1: Pharmacokinetics(Up to 24 months)
- Phase 1: Confirmed Objective Response Rate (ORR)(Up to 24 months)
- Phase 1 and 2: Tumor size(Up to 24 months)
- Phase 1 and 2: Duration of response (DOR)(Up to 24 months)
- Phase 1 and 2: Best overall response (OR)(Up to 24 months)
- Phase 1 and 2: Disease control rate (DCR)(Up to 24 months)
- Phase 1: Immunogenicity(Up to 24 months)
- Phase 1 and 2: Time to response (TTR)(Up to 24 months)