A Phase 2 Open-Label Study of Ozuriftamab Vedotin (BA3021) in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 7
- 主要终点
- Confirmed Objective Response Rate (ORR) per RECIST v1.1
研究概览
简要总结
This is a multi-center, open-label Phase 2 study designed to evaluate the efficacy and safety of BA3021 in PD-1/L1 failure patients with ROR-2 expression in recurrent or metastatic squamous cell carcinoma of the head and neck.
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
- •Histologically or cytologically confirmed recurrent or metastatic SCCHN Stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy). The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. Patients may not have a primary tumor site of nasopharynx (any histology).
- •Documented treatment failure of no more than one approved PD-1/L1 inhibitor either administered alone or in combination.
- •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 1.
排除标准
- •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 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
Cohort M1
Monotherapy BA3021 Q2W dosing regimen
干预措施: Ozuriftamab Vedotin (Biological)
Cohort M2
Monotherapy BA3021 2Q3W dosing regimen
干预措施: Ozuriftamab Vedotin (Biological)
Cohort N1
Neoadjuvant/induction setting combination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen prior to surgery.
干预措施: Ozuriftamab Vedotin (Biological)
Cohort N1
Neoadjuvant/induction setting combination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen prior to surgery.
干预措施: Pembrolizumab (Biological)
Cohort N1
Neoadjuvant/induction setting combination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen prior to surgery.
干预措施: Evalstotug (BA3071) (Biological)
Cohort C1
Combination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen
干预措施: Ozuriftamab Vedotin (Biological)
Cohort C1
Combination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen
干预措施: Pembrolizumab (Biological)
Cohort C1
Combination therapy of BA3021 2Q3W dosing regimen, pembrolizumab Q3W dosing regimen, and BA3071 Q3W dosing regimen
干预措施: Evalstotug (BA3071) (Biological)
Cohort C2
Combination therapy of BA3021 2Q3W dosing regimen, and pembrolizumab Q3W dosing regimen
干预措施: Ozuriftamab Vedotin (Biological)
Cohort C2
Combination therapy of BA3021 2Q3W dosing regimen, and pembrolizumab Q3W dosing regimen
干预措施: Pembrolizumab (Biological)
Cohort C3
Combination therapy of BA3021 2Q3W dosing regimen and cetuximab QW dosing regimen
干预措施: Ozuriftamab Vedotin (Biological)
Cohort C3
Combination therapy of BA3021 2Q3W dosing regimen and cetuximab QW dosing regimen
干预措施: Cetuximab (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 or Serious Adverse Events as assessed by CTCAE v5
时间窗: Up to 24 months
Measured by frequency and severity of adverse events as assessed by CTCAE 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)
- Overall survival (OS)(Up to 24 months)
- Complete response (CR)(Up to 24 months)