NCT03433027已完成2 期
A Phase 2 Trial of Intratumoral EGFR Antisense DNA (BB-401) in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC) Who Have Failed All Available Standard Therapies
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 6
- 主要终点
- Overall Response (OR) of the injected tumor
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and efficacy of intratumoral injections with an Epidermal Growth Factor Receptor (EGFR) AntiSense DNA (BB-401) in patients with metastatic/recurrent HNSCC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 HNSCC
- •Failed (or are ineligible/decline to receive) all available standard therapies
- •Stable, treated brain metastases
- •One target lesion defined as measurable (via RECIST v1.1), with a maximum longest diameter of 4 cm, and suitable for injection
- •Eastern Cooperative Oncology Group (ECOG) 0-2
- •Agree to biopsies of a selected primary lesion and where possible of a second untreated lesion at baseline and end of treatment
- •Ceased anti-cancer therapy for at least 3 weeks or 5 half-lives for chemotherapy based treatment regimen, or 4 weeks from any therapy with therapeutic biologicals or any type of investigational therapy
排除标准
- •Nasopharyngeal Carcinoma
- •Concomitant anti-cancer therapy
- •Unresolved toxicities from prior treatments
- •Patients in whom the indicator lesion is at risk of hemorrhage or clinically significant swelling/inflammation
研究组 & 干预措施
BB-401
Experimental
BB-401 Intratumoral injection
干预措施: BB-401 (Drug)
结局指标
主要结局
Overall Response (OR) of the injected tumor
时间窗: Up to 20 months (estimated length of the study)
Overall response is defined as Complete Response (CR) or Partial Response (PR) as evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee version 1.1
次要结局
- Overall Survival (OS)(Up to 20 months (estimated length of study))
- Duration of Response (DoR)(20 months (estimated length of study))
- Disease Control Rate (DCR)(End of Treatment Visit (Week 9) through to study end (up to 18 months))
- Progression Free Survival (PFS)(Up to 20 months (estimated length of study))
研究者
研究点 (6)
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