A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of CDX-3379 in Combination With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 10
- 主要终点
- Objective Response Rate
研究概览
简要总结
This is a study to determine the clinical benefit (how well the drug works), safety and tolerability of combining CDX-3379 and cetuximab. The study will enroll patients with advanced head and neck squamous cell carcinoma who have previously received cetuximab and progressed.
详细描述
CDX-3379 is a fully human monoclonal antibody that binds to a molecule called human epidermal growth factor receptor 3 (HER3 or ErbB3) found on certain cells and may act to promote anti-tumor effects.
Cetuximab is a human monoclonal antibody that blocks EGFR, a protein receptor that regulates cell growth.
This study will evaluate the safety, tolerability and efficacy of CDX-3379 in combination with cetuximab in patients with advanced head and neck squamous cell carcinoma who have previously received cetuximab and progressed.
Eligible patients that enroll in the study will be given the dose of 12 mg/kg CDX-3379 once every 3 weeks in combination with 400 mg/m2 cetuximab on the first day followed by weekly doses of 250 mg/m2 cetuximab.
Up to 45 patients will be enrolled. All patients enrolled in the study will be closely monitored to determine if there is a response to the treatment as well as for any side effects that may occur.
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 head and neck squamous cell carcinoma.
- •Human papilloma virus (HPV) negative tumor.
- •Prior treatment with a check-point inhibitor targeting PD-1, unless not a candidate.
- •Prior treatment with cetuximab with tumor progression during or within 6 months after completing treatment.
- •Measurable disease.
- •Life expectancy ≥ 12 weeks.
- •If of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 6 months following last treatment.
- •Willingness to undergo a tumor biopsy prior to starting treatment (or if biopsy is not feasible, provide archival tissue).
排除标准
- •Previous treatment with CDX-3379 or other anti-ErbB3 targeted agents.
- •Nasal, paranasal sinus, or nasopharyngeal carcinoma, aside from WHO Type I and II (keratinizing, non-EBV positive) nasopharyngeal carcinoma which will be allowed.
- •Major surgery within 4 weeks prior to first dose of study treatment.
- •Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to first dose of study treatment.
- •Monoclonal based therapies within 4 weeks (excluding cetuximab) and all other immunotherapy within 2 weeks prior to first dose of study treatment.
- •Other prior malignancy, active within 3 years, except for localized prostate cancer, cervical carcinoma in situ, non-melanomatous carcinoma of the skin, stage 1 differentiated thyroid cancer or ductal carcinoma in situ of the breast.
- •Active, untreated central nervous system metastases.
- •Active autoimmune disease or documented history of autoimmune disease.
- •Significant cardiovascular disease including CHF or poorly controlled hypertension.
研究组 & 干预措施
CDX-3379 and cetuximab
During the treatment phase of the study, eligible patients will receive assigned treatments in 3 week cycles until progression.
干预措施: CDX-3379 and cetuximab (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: The proportion of evaluable patients who achieve a best overall response of complete or partial response according to RECIST 1.1 assessed up to 24 months.
The percentage of patients who achieve a complete response or partial response per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST version 1.1), Complete Response (CR) = disappearance of all target lesions and non-target lesions, Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions.
次要结局
- Overall Survival (OS)(The time from start of study drug to death from any cause (up to approximately 2 years))
- Clinical Benefit Response (CBR)(Every 8 weeks, starting with first dose until disease progression, assessed up to approximately 2 years)
- Duration of Response (DOR)(First occurrence of a documented objective response to disease progression or death (up to approximately 2 years))
- Progression-free Survival (PFS)(From first dose to the first occurrence of disease progression or death due to any cause (up to approximately 2 years))
- Incidence of Adverse Events [Safety and Tolerability](Following at least one dose of study treatment through 30 days after last dose of CDX-3379.)
- Tumor DNA Biomarkers.(Tumor tissue is obtained during screening window via single biopsy procedure.)