An Open-label, Single Arm, Phase II Trial to Investigate the Safety and Efficacy of Sym004 in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) Who Have Failed Anti-EGFR Monoclonal Antibody-based Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 10
- 主要终点
- Progression Free Survival (PFS) Time
研究概览
简要总结
The trial is designed as a multi-center, open label Phase 2 trial that investigates the efficacy and safety of Sym004 in subjects with squamous cell cancer of the head and neck (SCCHN). Subjects included must have responded to previous anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody-based therapy and subsequently become resistant to that therapy. It is believed that Sym004 has the potential to induce tumor responses and provide a superior treatment option to subjects with advanced SCCHN.
Symphogen was the sponsor for planning/conducting and reporting results for this trial.
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 confirmed diagnosis initially or at relapse of SCCHN of the oral cavity, oropharynx, hypopharynx or larynx
- •Recurrent and/or metastatic SCCHN not amenable to curative treatment with surgery and/or (chemo)radiation
- •Previous treatment with an anti-EGFR monoclonal antibody (mAb) in the palliative setting either as monotherapy or in combination with chemotherapy or radiotherapy and showing:
- •Documented clinical benefit or response for at least 8 weeks (PR, CR or SD) on the anti-EGFR mAb-based therapy and
- •Documented disease progression (verified by computed tomography [CT] scan or magnetic resonance imaging [MRI] according to RECIST (1.1) during or within 12 weeks following the last administration of anti-EGFR mAb
- •Accessible tumor for biopsy and subject acceptance of repeat tumor biopsies
- •Other protocol-defined inclusion criteria could apply
排除标准
- •More than 2 lines of prior chemotherapy in the palliative setting
- •Expected survival <12 weeks
- •Subjects with known brain metastases
- •Chemotherapy or radiation therapy within 21 days prior to Visit 2 at the exception of palliative radiotherapy for bleeding or pain, which is allowed anytime, if not given on target lesions
- •Anti-EGFR mAbs within 14 days prior to Visit 2
- •Major surgery within 4 weeks prior to Visit 2 and subjects must have recovered from effects of major surgery
- •Other protocol-defined exclusion criteria could apply
研究组 & 干预措施
Sym004
干预措施: Sym004 (Drug)
结局指标
主要结局
Progression Free Survival (PFS) Time
时间窗: Time from the first infusion of Sym004 until progressive disease or death, assessed up to 24 weeks
The PFS time was defined as the time from first infusion of Sym004 until progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. or death. PD was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on trial. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The unequivocal progression of existing non-target lesions and the appearance of one or more lesions was also considered progression. Subjects who died without confirmed PD were considered as progressed. Subjects who died or showed PD more than 21 days after last treatment were censored (that is, were considered alive without progression on Day 21 after last treatment). Evaluation was done using Kaplan-Meier estimates.
次要结局
- Minimum Serum Concentration (Cmin)(Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3)
- Duration of Overall Response(Time from first infusion of Sym004 until disease progression or death, assessed up to 18 months)
- Area Under the Serum Concentration Curve From Time Zero to Infinity (AUC [0-inf])(Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3)
- Maximum Serum Concentration (Cmax)(Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3)
- Time to Progression (TTP)(Time from first infusion of Sym04 until disease progression, assessed up to 18 months)
- Objective Tumor Response and Derived Endpoints (Objective Response Rate and Disease Control Rate)(Time from first infusion of Sym004 until disease progression or death, assessed up to 18 months)
- Overall Survival Time(Time from first infusion of Sym004 until death, assessed up to 18 months)
- Number of Subjects With Detectable Biomarkers at Any Visit(Weeks 0 and 4; and 4 weeks after last dose)
- Area Under the Serum Concentration Curve From Time Zero to 168 Hours (AUC [0-168])(Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3)
- Time to Reach Minimum Serum Concentration (Tmin)(Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3)
- Clearance (CL)(Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3)
- Terminal Half Life (T1/2)(Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3)
- Time to Reach Maximum Serum Concentration (Tmax)(Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3)
- Volume of Distribution (Vz)(Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3)
- Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Death and AEs Leading to Discontinuation(From the first dose of study drug administration up to 4 weeks after the last dose of study drug administration)