A Phase Ib/II, Multicenter Study of LJM716 in Combination With Cetuximab in Patients With Platinum-pretreated Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Phase Ib: Number of Total Dose-limiting Toxicity (DLT) During Dose Escalation to Determine Maximum Tolerated Dose (MTD)
研究概览
简要总结
To establish whether LJM716 in combination with cetuximab is safe and has beneficial effects in patients with platinum-pretreated recurrent/metastatic head and neck squamous cell carcinoma.
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
- •Most recent regimen contains both platinum and cetuximab (Phase II, group B).
- •ECOG Performance Status (PS) ≤
- •Recovery from all AEs of previous anti-cancer therapies, to baseline or to CTCAE Grade ≤ 1, except for alopecia.
- •Measurable disease as determined by RECIST v1.1.
排除标准
- •Previous anti-HER3 antibody treatment.
- •Symptomatic brain metastasis.
- •Prior systemic anti-cancer treatment, within a period of time that is shorter than the cycle length used for that treatment prior to starting study treatment.
- •Prior anaphylactic or other severe infusion reaction to human immunoglobulin or antibody formulations.
- •Inadequate end organ function.
- •Ongoing diarrhea CTCAE Grade ≥
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Phase Ib: Number of Total Dose-limiting Toxicity (DLT) During Dose Escalation to Determine Maximum Tolerated Dose (MTD)
时间窗: 35 days
The dose escalation part of the study will be guided by a well-established statistical method/model to estimate the maximum tolerated dose of LJM716 in combination with cetuximab
Phase Ib: Target lesion change compared to baseline in patients, per RECIST 1.1
时间窗: 6 months
Assessment of the preliminary anti-tumor activity of LJM716 in combination. Change in target lesion measurements, from baseline as per RECIST 1.1
Phase II: Percentage of Patients with an Objective Overall Response (OOR) per RECIST 1.1
时间窗: 6 months
Patients with an Objective Overall Response (OOR) were those whose best response to treatment was a complete response (CR) or a partial response (PR) assessed by imaging, as pr RECIST 1.1.
次要结局
- Duration of response (DOR) per RECIST 1.1(6 months)
- blood concentration versus time profiles blood PK parameters of LJM716 and cetuximab concentration(6 months)
- Best overall response (BOR), per RECIST 1.1(6 months)
- Safety and tolerability of the LJM716- cetuximab combination(6 months)
- Overall survival (OS) per RECIST 1.1(12 months)
- Progression free survival (PFS) per RECIST 1.1(6 months)