An Exploratory, Open Label, Multi-Center, Non-Randomized Study of [F-18]VM4-037
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Safety will be the outcome demonstrated in this clinical trial through analyses of adverse events in subjects who receive study drug.
研究概览
简要总结
Phase: Exploratory Study
Objectives: To collect drug bio-distribution data, begin collection of baseline and tumor/background imaging data, acquire experience to improve study design and the conduct of future studies
Design: Exploratory, open label, nonrandomized, multi-center study
Duration: Three visits - one screening, one imaging, and one follow-up visit at 24 hours post-dose
Procedures: Informed consent, collection of demographic information and medical history, physical examinations, vital signs, 12-lead ECGs, routine blood tests to assess major organ functions, complete blood counts and clinical chemistries for safety, blood sample for CA-IX assay, pre-dose and post-dose blood samples for metabolite analysis, dosing with [F-18]VM4-037, PET imaging scan, dosimetry estimation (normals), urine collections (normals), tumor immunohistochemistry with CA-IX biomarker, follow up to imaging to collect adverse events
Subjects: Approximately sixteen (16) adult subjects including four (4) healthy volunteers and twelve (12) cancer subjects who have confirmed or highly suspected diagnosis of head & neck, lung, large solitary hepatic and renal cell cancer, as defined by protocol criteria
详细描述
[F-18]VM4-037 is being developed as a diagnostic radiopharmaceutical for PET imaging.
SMI is seeking to determine if [F-18]VM4-037 might be useful as a PET ligand for the in vivo imaging of CA-IX levels in human tissue.
CA-IX is a very active enzyme which may acidify the extracellular microenvironment of tumor cells in response to hypoxia. Its expression usually promotes tumor growth and invasion, and thus impairs prognosis.
VM4-037 presents no known risks from either in vitro study in cell lines or in vivo study in animals according to in-house preclinical investigations of this compound.
The population to be studied consists of a total of approximately sixteen (16) adult subjects, which includes four normal, healthy volunteers and twelve cancer subjects with a confirmed or highly suspected diagnosis of head and neck cancer, non-small cell lung cancer, large solitary hepatic carcinoma, and renal cell carcinoma as defined by the protocol criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Normal Volunteers
- •Subject is ≥ 18 years old at the time of investigational product administration, and subject is male or female of any race / ethnicity
- •Subject or subject's legally acceptable representative provides written informed consent
- •Subject is capable of complying with study procedures
- •Subject is capable of communicating with study personnel
- •Subject must have renal and hepatic functions and haematological values as defined by laboratory results within defined ranges
- •Cancer Subjects
- •Subject is ≥ 18 years old at the time of the investigational product administration, and subject is a male or female of any race/ethnicity
- •Subject or subject's legally acceptable representative provides written informed consent
- •Subject is capable of complying with study procedures
- •Subject is capable of communicating with study personnel
- •Subject must have renal and hepatic functions and haematological values as defined by laboratory results within defined ranges
- •Subject must have confirmed or highly suspected non-small cell lung cancer (local or with metastases), squamous cell carcinoma (advanced stages) of the head and neck whose primary origin was from oral cavity, oropharynx, hypopharynx or larynx (local or with metastases), large solitary hepatic carcinoma (primary or metastatic), or renal cell carcinoma (local or with metastases )
- •Subject has an adequate size of tumors (≥2 cm) that should be amenable to imaging and biopsy for immunohistochemistry assay using CA-IX and/or hypoxia biomarkers
- •Subject did not have any anticancer treatment intervention between [F-18]VM4-037 scan and sampling of biopsied tissue
- •Subject is scheduled for a clinical [F-18]FDG PET scan within 14 days either prior to or after the investigational, [F-18]VM4-037 scan (with no anticancer treatment interventions between the two PET scans)
- •Subject has a value of ≥ 60% at the time screening according to the Karnofsky Performance Status Scale
排除标准
- •Normal Volunteers
- •Subject is < 18 years old at the time of investigational product administration
- •Subject is nursing
- •Female subject is pregnant
- •Subject is unable to remain still for duration of imaging procedure
- •Subject has a significant hepatic or renal disease as defined by previous medical history or abnormal renal and hepatic functions determined by above lab tests in inclusion criteria
- •Subject has previously received [F-18]VM4-037 at any time
- •Subject has been involved in an investigative, radioactive research procedure within the past 14 days
- •Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data or data quality
- •Subject has a history of significant prescription or non-prescription drug, or alcohol abuse, including but not limited to marijuana, cocaine, heroin or derivatives
- •Cancer Subjects
- •Subject is < 18 years old at the time of investigational product administration
- •Subject is nursing
- •Female subject is pregnant
- •Subject is unable to remain still for duration of imaging procedure
- •Subject has significant hepatic or renal disease as defined by previous medical history or abnormal renal and hepatic functions determined by above lab tests in inclusion criteria
- •Subject has previously received [F-18]VM4-037 at any time
- •Subject has been involved in an investigative, radioactive research procedure within the past 14 days
- •Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data or data quality
- •Subject has a history of significant prescription or non-prescription drug, or alcohol abuse, including but not limited to marijuana, cocaine, heroin or derivatives
- •Subject has had an anticancer treatment intervention between [F-18]VM4-037 scan and biopsied tissue sampling
- •Subject has had an anticancer treatment intervention between [F-18]VM4-037 scan and [F-18]FDG scan
- •Subject has an inadequate tumor sites or volume (< 2 cm) to allow for PET images and biopsy for immunohistochemistry
研究组 & 干预措施
VM4-037
Approximately sixteen (16) adult subjects including four (4) healthy volunteers and twelve (12) cancer subjects who have confirmed or highly suspected diagnosis of head & neck, lung, large solitary hepatic and renal cell cancer, as defined by protocol criteria
干预措施: [F-18] VM4-037 (Drug)
结局指标
主要结局
Safety will be the outcome demonstrated in this clinical trial through analyses of adverse events in subjects who receive study drug.
时间窗: (3) study visits, including the initial screening visit, the imaging visit, and the 24 hour follow-up visit
次要结局
未报告次要终点