A Phase 1 Study of [225Ac]-FPI-2059 in Adult Participants With NTSR1-Expressing Advanced, Metastatic and/or Recurrent Solid Tumours
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 8
- 主要终点
- Radiation dose of [111In]-FPI-2058 and [225Ac]-FPI-2059 to whole body, organs, and selected regions of interest
研究概览
简要总结
This is a first-in-human Phase 1 clinical trial designed to investigate the safety, tolerability, pharmacokinetics, and biodistribution of [225Ac]-FPI-2059 and [111In]-FPI-2058 in participants with neurotensin receptor 1 (NTSR1)-expressing solid tumours.
详细描述
This is a first-in-human, Phase 1, non-randomized, multi-centre, open-label clinical trial designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics (PK) of [225Ac]-FPI-2059 and [111In]-FPI-2058, as well as the pharmacodynamics and preliminary anti-tumour activity of [225Ac]-FPI-2059 in participants with neurotensin receptor 1 (NTSR1)-expressing advanced, metastatic and/or recurrent solid tumours.
The study will employ a 3+3 dose escalation design to identify the recommended phase 2 dose (RP2D) and regimen of [225Ac]-FPI-2059 administered intravenously every 56 days.
After the RP2D for [225Ac]-FPI-2059 is determined, enrolment will continue into an expansion cohort, to confirm the safety and tolerability of the RP2D, as well as to identify any preliminary evidence of efficacy in selected NTSR1-expressing tumour types.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Signed ICF prior to initiation of any study-specific procedures
- •Histologically and/or cytologically confirmed solid tumor that is metastatic or locally advanced, inoperable, or recurrent. Solid tumors indications may include PDAC, CRC, NED prostate cancer, gastric cancer, SCCHN, and Ewing sarcoma.
- •Disease that has progressed despite prior treatment, and for which additional effective standard therapy is not available or is contraindicated, not tolerable, or the patient refuses standard therapy
- •Measurable disease per RECIST v.1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Sufficient target expression in at least one measurable lesion as determined by imaging following injection of [111In]-FPI-2058
- •Adequate organ function
- •Tumor tissue (either archival within the last 24 months or fresh biopsy)
排除标准
- •Previous treatment with any radiopharmaceutical
- •Contraindications to or inability to perform the imaging procedures required in this study
- •Anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal therapy, targeted therapy, or investigational agents within certain amount of time prior to administration of the first dose of [111In]-FPI-2058
- •Radiation therapy (RT) within 28 days prior to the first dose of [111In]-FPI-2058
- •Patients with known CNS metastatic disease
- •Concurrent severe and/or uncontrolled illness that would limit compliance with study requirements
- •Known or suspected allergies or contraindication to the investigational treatment
- •Received any type of vaccine within 30 days prior to the first dose of [111In]-FPI-2058
研究组 & 干预措施
Phase 1 Dose Escalation
干预措施: [225]-FPI-2059 (Drug)
Phase 1 Dose Escalation
干预措施: [111In]-FPI-2058 (Drug)
Phase 1 Dose Expansion
干预措施: [225]-FPI-2059 (Drug)
Phase 1 Dose Expansion
干预措施: [111In]-FPI-2058 (Drug)
结局指标
主要结局
Radiation dose of [111In]-FPI-2058 and [225Ac]-FPI-2059 to whole body, organs, and selected regions of interest
时间窗: within 56 days of administration
Maximum tolerated dose (MTD) of [225Ac]-FPI-2059
时间窗: 56 days post administration
Incidence of Adverse Events to evaluate safety and tolerability of [225Ac]-FPI-2059 and [111In]-FPI-2058
时间窗: approximately 5 years post final administration
次要结局
- Pharmacokinetics (PK) of [225Ac]-FPI-2059 and [111In]-FPI-2059 by measuring changes in clearance, AUC, Cmax, and half-life(approximately 36 days of final administration)
- Anti-tumor activity of [225Ac]-FPI-2059 regimen measured by response per RECIST v1.1(approximately 5 years post final administration)
- Tumor uptake of [111In]-FPI-2058 by evaluating SPECT/CT and planar images(within 56 days of administration)