A Single-arm, Open-Label, Multicenter Phase II Clinical Study to Evaluate Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) in Patients With Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma (CSCC)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
Following basal cell carcinoma, Cutaneous Squamous Cell Carcinoma (CSCC) is the most common skin cancer and its incidence remains on a steady rise. The vast majority of CSCC lesions are treated with surgical resection and have a cure rate exceeding 90 percent in early-stage disease. In stark contrast, the 5-year overall survival rate is below 50% for locally advanced patients and less than 10 percent for those with distant metastases. Although the commonly used cisplatin-based combination chemotherapies may achieve an overall response rate of up to 80%, the efficacy is usually not durable. Moreover, the use of chemotherapy is limited due to the many adverse events, especially in elderly patients, who are the largest population of concern for CSCC. The purpose of this study was to assess safety, efficacy in patients with locally advanced or metastatic CSCC given HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection).
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
- •Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF); be willing to follow and be able to complete all study procedures;
- •Aged ≥ 18 years.
- •Histopathologically or cytologically confirmed diagnosis of locally advanced or metastatic Cutaneous Squamous Cell Carcinoma (CSCC).
- •Measurable lesion according to RECIST v1.1 by IRRC.
- •ECOG score 0-
- •Expected survival 12 weeks.
- •For fertile female subjects, the pregnancy test must be negative within 7 days before the first dose.
排除标准
- •Prior systemic anti-EGFR monoclonal antibody therapy.
- •A history of other malignancies within three years, except for cured cervical carcinoma in situ, adenocarcinoma in situ of the breast, or tumors that do not require interventional treatment after radical surgery.
- •Participant has any other histologic type of skin cancer, eg, basal cell carcinoma that has not been definitively treated with surgery or radiation, Bowen's disease, MCC, melanoma.
- •Participants with any prior allogeneic solid organ or bone marrow transplantations.
- •Symptomatic brain or meningeal metastases (unless the patient has been on > treatment for 3 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
- •Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage.
- •Active clinical severe infection.
研究组 & 干预措施
HLX07
HLX07 1500mg ivgtt Q3W
干预措施: HLX07 (Drug)
结局指标
主要结局
ORR
时间窗: up to 2 years
Objective response rate by IRRC assessment per RECIST v1.1
PFS
时间窗: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years
Progression-free survival by independent radiological review committee (IRRC) assessment per RECIST v1.1
次要结局
- OS(from the date of first dose unitl the date of death from any cause，assessed up to 2 years)
- DOR(from the date when CR or PR (whichever recorded earlier) is firstly achieved until the date when disease progression or death is firstly recorded (whichever occurs earlier),assessed up to 2 years)