A Proof-of-Concept Clinical Trial of Intratumoral Injection of GLA-SE, a Toll-like Receptor-4 Agonist, in Patients With Merkel Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Safety and feasibility
研究概览
简要总结
This is a single arm, open-label, single center study evaluating the safety, feasibility, clinical efficacy and immunogenicity of GLA-SE administration to patients with Merkel cell carcinoma. Ten patients will be treated. The goal is for GLA-SE to assist the patient's own immune system in attacking the cancer cells.
详细描述
This is a single arm, open-label, single center study evaluating the safety, feasibility, clinical efficacy and immunogenicity of GLA-SE administration to patients with Merkel cell carcinoma. Ten patients with metastatic or locoregional disease will be treated. The goal is for GLA-SE to assist the patient's own immune system in attacking the cancer cells.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy-confirmed Merkel cell carcinoma with metastatic or loco-regional disease.
- •Patients must have at least one injectable lesion, defined as an easily palpable superficial lesion (cutaneous, subcutaneous or lymph nodal metastasis) that can be accurately localized, stabilized by palpation, and is superficial enough to enable IT injection.
- •ECOG performance status score 0, 1 or 2
- •≥ 18 years of age
- •Life expectancy of ≥ three months.
- •Adequate neutrophil and platelet counts
- •Adequate renal and hepatic function
- •Willing to undergo pre-treatment lesion biopsy and post-treatment lesion biopsy
- •Use of effective contraception
- •Signed informed consent document
- •Members of all genders, races and ethnic groups are eligible for this trial
排除标准
- •Prior chemotherapy or a major surgical procedure within 3 weeks, or radiotherapy within 2 weeks prior to first study treatment
- •No concurrent anti-cancer treatment (including topical agents such as imiquimod) or investigational agents
- •Active, untreated brain metastases
- •Pregnant or nursing
- •Use of any systemic immunosuppressive agents
- •Immunosuppressed patients
- •Uncontrolled depression or other major psychiatric disorder
研究组 & 干预措施
GLA-SE
Glucopyranosyl Lipid A in Stable Emulsion
干预措施: GLA-SE (Biological)
结局指标
主要结局
Safety and feasibility
时间窗: 1 year
The number of treatment-related adverse events
次要结局
- Clinical efficacy and Immunogenicity(1 Year)