NCT05513573进行中（未招募）2 期
A Randomized, Double-Blind, Multi-Center Phase II Clinical Study to Compare the Efficacy and Safety of HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection) + Serplulimab (HLX10, Recombinant Anti-PD-1 Humanized Monoclonal Antibody) +Chemotherapy Versus Placebo + Serplulimab + Chemotherapy in First-Line Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
Shanghai Henlius Biotech1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年12月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
A Randomized, Double-Blind, Multi-Center Phase II Clinical Study to Compare the Efficacy and Safety of HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection) + Serplulimab (HLX10, Recombinant Anti-PD-1 Humanized Monoclonal Antibody) +Chemotherapy Versus Placebo + Serplulimab + Chemotherapy in First-Line Treatment of Patients with Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Voluntarily participate in the clinical study; fully understand, be informed about the study, and have signed the informed consent form (ICF); be willing to follow and be able to complete all trial procedures.
- •Males or females aged ≥ 18 years at the time of signing the ICF.
- •Histologically or cytologically proven recurrent or metastastic NPC.
- •At least one measurable target lesion is assessed by the IRRC according to the RECIST v1.1 within 4 weeks prior to randomization.
- •An ECOG performance status score of 0-1 within 7 days prior to the first dose of the investigational product.
- •An expected survival period ≥ 12 weeks.
排除标准
- •Other active malignancies within 3 years prior to the first dose of investigational product. Localized tumors that have been cured such as superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, and breast cancer in situ are acceptable.
- •Patients who are going to receive or have received an organ or bone marrow transplant.
- •With uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage (monthly or more frequently).
- •With cerebrovascular accident, myocardial infarction, unstable angina, poorly controlled arrhythmia (including QTc intervals ≥ 450 ms for males and ≥ 470 ms for females) (QTc intervals are calculated by Fridericia formula) within half a year.
- •Class III to IV cardiac insufficiency according to New York Heart Association (NYHA) classification (Appendix 5) or an LVEF (left ventricular ejection fraction) < 50% by cardiac color Doppler.
- •Inadequately controlled hypertension (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg).
- •With human immunodeficiency virus (HIV) infection.
研究组 & 干预措施
Placebo+HLX10+chemotherapy
Experimental
干预措施: HLX10 (Drug)
HLX07+HLX10+chemotherapy
Experimental
干预措施: HLX07 (Drug)
HLX07+HLX10+chemotherapy
Experimental
干预措施: HLX10 (Drug)
HLX07+HLX10+chemotherapy
Experimental
干预措施: chemotherapy (Drug)
Placebo+HLX10+chemotherapy
Experimental
干预措施: placebo (Drug)
Placebo+HLX10+chemotherapy
Experimental
干预措施: chemotherapy (Drug)
结局指标
主要结局
ORR
时间窗: up to 24 weeks
Objective response rate (ORR) (assessed by the IRRC according to the RECIST v1.1 criteria)
次要结局
- PFS(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 14 months)
研究者
研究点 (1)
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