A Phase 2a, Single-dose, Open-label Study to Evaluate Diagnostic Performance, Safety & Timing of Postdose Imaging of ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer, in Patients With Solid Tumors Undergoing Routine Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Measure Mean Fluorescence Intensity of Histologically Confirmed Tumor vs Normal Tissue in Patients Undergoing Routine Surgery [Tumor to Background Ratio (TBR)]
研究概览
简要总结
This study is to evaluate diagnostic performance, safety and timing of post-dose imaging of ONM-100, an intraoperative fluorescence imaging agent for the detection of cancer in patients with solid tumors undergoing routine surgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy-confirmed diagnosis of primary or recurrent respective tumor type and scheduled to undergo surgical resection
- •Part 1: Biopsy-confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) or breast cancer
- •Part 2: Biopsy-confirmed diagnosis of HNSCC, breast cancer, colorectal cancer, prostate cancer, ovarian cancer, urothelial carcinoma and non-small cell lung cancer.
- •Part 3: Stage 2 to 4 HNSCC Including T0 or Tx unknown Primary cancers
排除标准
- •Histologically diagnosed by an excisional biopsy procedure
- •Tumors at sites of which the surgeon would assess that in vivo intraoperative imaging would not be feasible
- •Life expectancy <12 weeks
- •Hepatic impairment (Child-Pugh score >5) or significant liver disease including active hepatitis or cirrhosis
研究组 & 干预措施
Patients receiving ONM-100
All patients in this arm will receive ONM-100 for injection and undergo intraoperative imaging.
干预措施: ONM-100 (Drug)
结局指标
主要结局
Measure Mean Fluorescence Intensity of Histologically Confirmed Tumor vs Normal Tissue in Patients Undergoing Routine Surgery [Tumor to Background Ratio (TBR)]
时间窗: 1 day
Part 1: Evaluate the dose(s) at which ONM-100 fluorescence imaging is feasible at 3±2 hours post dose. Part 2: Verify the safety and diagnostic performance of ONM-100 compared to standard pathology at the dose(s) and imaging schedule(s) post dose selected from Part 1 for the detection of primary tumors and the metastatic lymph nodes in a variety of solid cancers (which could have included HNSCC, breast cancer, colorectal cancer, urothelial cancer, prostate cancer, ovarian cancer, and/or non-small cell lung carcinoma \[NSCLC\]). Part 3: Assess the safety and efficacy (sensitivity and positive predictive value \[PPV\] of ONM-100 for intraoperative imaging during HNSCC surgery.
Incidence Rate of All Treatment-emergent Adverse Events (TEAEs) From Time of ONM-100 Administration Through Day 28
时间窗: 28 days
Evaluate safety at the dose(s) used to assess imaging feasibility and select the dose(s) and imaging schedule(s) post dose that are safe and provide optimal imaging of solid tumors and metastatic lymph nodes; the dose and time post dose chosen for the detection of primary tumors and metastatic lymph nodes could be the same or different.
次要结局
- Evaluate Pharmacokinetic Parameters: t1/2(6 days)
- Evaluate Pharmacokinetic Parameters: Cmax(6 days)
- Evaluate Pharmacokinetic Parameters: Tmax(6 days)
- Evaluate Pharmacokinetic Parameters: AUC(6 days)
- Evaluate Pharmacokinetic Parameters: CL(6 days)
- Evaluate Pharmacokinetic Parameters: Vz(6 days)