A Phase I Multicentre Open-label Study to Evaluate Safety, Tolerability, and Dosimetry of [111In]-FPI-2107 in Chinese Adult Participants With EGFR Mutation-positive NSCLC
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 6
- 试验地点
- 6
- 主要终点
- Safety and tolerability of [111In]-FPI 2107 following the administration of FPI 2053
研究概览
简要总结
This is a Phase I, multicentre, open-label clinical study designed to investigate the safety, tolerability, dosimetry, biodistribution, PD, and PK of [111In]-FPI-2107 after pre-dose administration of FPI-2053 in Chinese participants with EGFR mutation-positive NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed EGFR mutation positive NSCLC.
- •Without any ongoing anti-cancer therapy or with stable ongoing anti-cancer therapy.
- •At least one lesion that is present on 18F-FDG PET/CT scan during screening.
- •ECOG performance status of 0 or
- •Anticipated life expectancy ≥ 12 weeks, in the opinion of the Investigator.
- •Able to provide tumour tissue for analysis.
排除标准
- •Confirmed radiographic disease progression or Investigator-assessed clinical disease progression within 28 days prior to the administration of [111In]-FPI-
- •Contraindications to or inability to perform the imaging procedures required in this study.
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (≥ once per month).
- •History of myocardial infarction or New York Heart Association Class II-IV congestive heart failure within 6 months of the administration of [111In]-FPI-2107, CTCAE Grade 2 or worse conduction defect or uncontrolled hypertension.
- •Clinically relevant proteinuria, or daily urinary protein excretion > 500 mg).
- •Any antibody-based therapy targeting EGFR and/or c-MET, or investigational agent within 28 days or 5 half-lives prior to the administration of [111In]-FPI-2107, whichever is shorter.
- •Any systemic radiopharmaceutical within 28 days or 5 radioactive half-lives prior to the administration of [111In]-FPI-2107, whichever is shorter.
- •Any anticipated need for switching of any concomitant anti-cancer therapy during the imaging period of the study.
- •External beam radiation therapy within 28 days prior to the administration of [111In]-FPI-2107.
研究组 & 干预措施
[111In]-FPI-2107 and FPI-2053
2 study interventions both based on the same EGFR and c-MET bispecific antibody
干预措施: FPI-2053 (Drug)
[111In]-FPI-2107 and FPI-2053
2 study interventions both based on the same EGFR and c-MET bispecific antibody
干预措施: [111In]-FPI-2107 (Drug)
结局指标
主要结局
Safety and tolerability of [111In]-FPI 2107 following the administration of FPI 2053
时间窗: From the screening period to 21 days after dosing
Safety and tolerability will be evaluated by frequency, duration, and severity of AEs, and changes in clinical, laboratory, and ECG parameters compared to baseline
Dosimetry parameter of [111In]-FPI 2107 following the administration of FPI 2053
时间窗: During the Imaging period (Day1 - Day4/5)
Residence time of the segmented source organs
次要结局
- Tumour uptake of [111In]-FPI-2107(During the Imaging period (Day1 - Day4/5))
- PK of [111In]-FPI-2107: Peak Plasma Concentration (Cmax)(From the dose of investigation product (Day 1) until Day 4/5)
- PK of [111In]-FPI-2107: AUClast(From the dose of investigation product (Day 1) until Day 4/5)
- PK of [111In]-FPI-2107: Clearance(From the dose of investigation product (Day 1) until Day 4/5)
- PK of [111In]-FPI-2107: Half-life(From the dose of investigation product (Day 1) until Day 4/5)