Phase Ib Trial of Multiple-ascending Doses of EMD 1201081 in Combination With 5-FU/Cisplatin and Cetuximab in First-line Subjects With Recurrent/ Metastatic Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Maximum-tolerated-dose (MTD) at 0.16 mg/kg cohort size testing
研究概览
简要总结
The primary purpose of this trial is to assess the safety and tolerability of EMD 1201081, a novel immunomodulatory agent that is an agonist of TLR9, in combination with 5-FU/cisplatin and cetuximab in first line treatment of patients with recurrent/metastatic squamous cell carcinoma of the head and neck, and to determine the maximum tolerated dose (MTD) among the dose levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 diagnosis of squamous cell carcinoma of the head and neck (SCCHN).
- •Recurrent and/or metastatic SCCHN, not suitable for local therapy.
- •At least 1 measurable lesion either by computerized tomography (CT) scan or magnetic resonance imaging (MRI) (according to RECIST 1.0).
- •Karnofsky performance status (KPS) of ≥ 70 / Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at trial entry.
排除标准
- •Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 2 months prior to trial entry.
- •Nasopharyngeal carcinoma.
- •Medical history of diagnosed interstitial lung disease.
- •Known hypersensitivity against any of the components of the trial treatment.
- •Previous treatment with experimental or non-approved epidermal growth factor receptor (EGFR) targeting therapy or experimental or nonapproved EGFR signal transduction inhibitors (prior treatment with cetuximab is allowed).
- •Relevant cardiovascular co-morbidities.
- •Concomitant chronic systemic immune therapy, or hormonal therapy as cancer therapy, steroid use ≥ 10 mg prednisone equivalent.
- •Known human immunodeficiency virus (HIV) positivity, active hepatitis C, or active hepatitis B.
研究组 & 干预措施
Arm 1 (Part 1)
干预措施: EMD 1201081 + 5-FU + Cisplatin + Cetuximab (Drug)
Arm 2 (Expansion cohorts -Part 2 and Part 2a)
干预措施: EMD 1201081 + 5-FU + Cisplatin + Cetuximab (Drug)
结局指标
主要结局
Maximum-tolerated-dose (MTD) at 0.16 mg/kg cohort size testing
时间窗: 3 weeks
Occurrence of treatment-related dose-limiting toxicity during the first cycle (3 weeks) of treatment in subjects treated with multi-ascending doses of EMD 1201081 in combination with 5-FU/cisplatin + cetuximab.
Maximum-tolerated-dose (MTD) at 0.32 mg/kg cohort size testing
时间窗: 3 weeks
Occurrence of treatment-related dose-limiting toxicity during the first cycle (3 weeks) of treatment in subjects treated with multi-ascending doses of EMD 1201081 in combination with 5-FU/cisplatin + cetuximab.
Maximum-tolerated-dose (MTD) at 0.48 mg/kg cohort size testing
时间窗: 3 weeks
Occurrence of treatment-related dose-limiting toxicity during the first cycle (3 weeks) of treatment in subjects treated with multi-ascending doses of EMD 1201081 in combination with 5-FU/cisplatin + cetuximab.
Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
时间窗: Baseline up to 49 days after last study drug administration
次要结局
- Number of subjects with best overall response(8 months)
- Pharmacokinetic parameters: Cmax, Tmax and AUC (0-t)(Days 1, 8 and 15)