A Phase I Clinical Study To Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) in Patients With Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The proportion of patients experiencing dose limiting toxicity (DLT) events
研究概览
简要总结
This Phase1, open-label and dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of HLX07 administered as a single-agent by IV infusion every 3 weeks to patients with locally advanced or metastatic solid malignancies, who have failed or are intolerant to standard therapy, or for whom no standard therapy is available.
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 75 Years（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);
- •Aged ≥ 18 years, ≤ 75 years;
- •Patients must have histologically confirmed malignant solid tumors which are advanced or metastatic, have failed prior standard treatment, and be intolerant or ineligible for standard therapy;
- •Measurable disease according to RECIST Version 1.1;
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
- •Expected survival 12 weeks;
- •Adequate organ function;
- •For fertile female subjects, the pregnancy test must be negative within 7 days before the first dose;
排除标准
- •Prior anti-EGFR (including EGFR ADC) monoclonal antibody therapy;
- •A history of other malignancies within two years, except for cured Localized tumor;
- •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
This study uses the "3+3" design to investigate the safety and determine the MTD of HLX07. Four dose levels of 800 mg, 1200 mg, 1500 mg and 1800 mg are planned for dose finding. Enrollment will continue until a maximum of 24 patients are enrolled.
干预措施: HLX07 (Drug)
结局指标
主要结局
The proportion of patients experiencing dose limiting toxicity (DLT) events
时间窗: from first dose to the end of Cycle 1 (each cycle is 21 days)
The Incidence of Treatment-Related Adverse Events
时间窗: 2 years
The maximum tolerated dose (MTD)
时间窗: from first dose to the end of Cycle 1 (each cycle is 21 days)
次要结局
- Objective response rate (ORR)(2 years)
- Peak plasma concentration (Cmax) of HLX07(2 years)
- Area under the concentration-time curve (AUC) of HLX07(2 years)
- Volume of distribution (Vz) of HLX07(2 years)
- Elimination half-life (t1/2) of HLX07(2 years)
- Clearance (CL) of HLX07(2 years)
- Accumulation Index (Rac) of HLX07(2 years)
- Incidence of treatment-emergent anti-drug antibodies (ADA)(2 years)
- Disease control rate (DCR)(2 years)
- Duration of response (DOR)(2 years)
- Time to peak (Tmax) of HLX07(2 years)