A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of VGT-309, a Tumor-Targeted, Activatable Fluorescent Imaging Agent, to Identify Cancer in Subjects Undergoing Lung Cancer Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Clinically Significant Event (CSE)
研究概览
简要总结
A Phase 2 open label study to evaluate safety and efficacy of VGT-309 to identify cancer in up to 40 subjects undergoing lung cancer surgery.
详细描述
A Phase 2, open-label study to evaluate the safety and efficacy of VGT-309, a tumor-targeted, activatable fluorescent imaging agent, to identify cancer in subjects undergoing lung cancer surgery. A total of 40 subjects will be enrolled to ensure at least 38 evaluable subjects with the option to expand enrollment by protocol amendment if deemed necessary to meet primary and/or secondary objectives.
Following agreement with and signing of the informed consent, subjects will undergo screening measurements for the study. Assessments include the following, unless they have been done within 4 weeks prior to the anticipated dosing:
- Medical, surgical and medication history.
- Complete physical exam, including vital signs and weight.
- Standard pre-operative chemistry, hematology, coagulation and urinalysis clinical laboratory studies.
- 12-lead ECG.
- Serum pregnancy test for females of child-bearing potential.
Following clearance of all enrollment criteria, each subject will receive an IV administration of 0.32 mg/kg VGT-309 at 12-36 hours prior to surgery (refer to section VGT-309 Dosing, below). Upon dosing, subjects will be observed for up to 2 hours and asked about possible treatment emergent adverse events.
Subjects will undergo surgical resection as planned and within the time specified following VGT-309 dosing. Measurements of efficacy will be taken during surgery and during the pathological examination of all surgical specimens.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be willing and able to sign the informed consent and comply with study procedures.
- •Be between the ages of 18 and 85, inclusive.
- •Be male or female and meet the following conditions:
- •Female participants must be of non-childbearing potential, or,
- •If of childbearing potential be non-pregnant or non-lactating and agree to use highly effective contraception from screening through Day
- •Male participants, if not surgically sterilized, and if engaging in sexual intercourse with a female partner of childbearing potential, must be willing to use highly effective contraception from screening through 30 days post-dose and agree not to donate semen during this waiting period.
- •Highly effective contraception involves the use of a condom for the male, plus one of the following for the female:
- •Oral, injectable, implantable, intravaginal, or transdermal hormonal contraceptives, or
- •Intrauterine device or intrauterine hormone-releasing system
- •NOTE: Participants who abstain from heterosexual intercourse as their usual and preferred lifestyle, will not be required to use contraception as described above.
- •They are required to maintain abstinence from screening through Day
- •Have a lung nodule or mass that might be considered primary lung cancer or lung metastases, whether or not it is biopsy-proven.
- •Be scheduled to undergo standard of care surgical resection for a lung nodule or mass with diagnostic and/or curative intent and meet all pre-operative surgical and anesthesia acceptance criteria.
- •Have acceptable kidney and liver functions at study entry as evidenced by:
- •Alanine Aminotransferase/Aspartate Aminotransferase (ALT/AST) < 1.5 times the upper limit of normal
- •Serum creatinine < 1.5 times the upper limit of normal
- •Have an Eastern Cooperative Oncology Group (ECOG) score of 0-
- •Meet all standard surgical and general anesthesia requirements.
- •Have not participated in a clinical trial within the last 30 days.
排除标准
- •They are not a candidate for standard of care surgery based on opinion of the surgeon, anesthesiologist, or other consulting physician.
- •They have a known allergy or reaction to indocyanine green (ICG), other radiographic contrast agent, or any component of VGT-
- •Have congenital long QT syndrome or QTcF > 450ms (males) or >470ms (females) by history or at Screening ECG.
- •They are prisoners, institutionalized individuals, or are unable to consent for themselves.
- •Have any other co-morbidity or habit that the Investigator believes will interfere with their ability to comply with and complete the study.
研究组 & 干预措施
0.32mg/kg VGT-309
Single arm in an open label study
干预措施: VGT-309 (Drug)
结局指标
主要结局
Clinically Significant Event (CSE)
时间窗: Day of surgery
Identification of the proportion of subjects with at least one CSE as defined by: A. Localization of a Pulmonary Nodule using VGT-309 near-infrared (NIR) Imaging when white light and palpation failed to identify a nodule. B. Synchronous Lesion Identification using VGT-309 NIR Imaging when not identified by white light and palpation. C. Positive Margin Identification with only VGT-309 NIR Imaging when deemed negative by the surgeon by white light and palpation.
次要结局
- Sensitivity(Day of surgery)
- Negative Predictive Value(Day of surgery)
- Specificity(Day of surgery)
- Positive Predictive Value(Day of surgery)