ACTRN12621000301864招募中2 期
A Phase 2, Open-label Study to Evaluate the Safety, Efficacy, Dosing, and Timing of VGT-309, a Tumor-Targeted, Activatable Fluorescent Imaging Agent for the Intraoperative Identification of Lung Cancer
Vergent Bioscience Australia, Pty Ltd0 个研究点目标入组 44 人开始时间: 2021年3月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 44
研究概览
简要总结
VGT-309 was shown to be well-tolerated with few side effects related to the study drug. Most of those were mild or moderate and required no additional treatment. One possible side effect was serious, resulting in elevations of some lab tests after surgery. This these tests returned to normal levels without treatment. Using VGT-309 and a special surgical fluorescence imaging system (that can make the lesions where VGT-309 has accumulated, glow), cancerous lesions were seen by the surgeon in 16 of the 27 trial subjects with brighter fluorescence observed at higher doses and longer periods of time between dosing and surgery. Importantly, in 8 subjects, the use of VGT-309 helped identiy cancer that would not have been found otherwise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Be willing and able to sign the informed consent and comply with study procedures
- •2. Be at least 18 years of age
- •3. Be scheduled to undergo planned standard of care surgical resection for a lung nodule or mass, whether or not it is biopsy-proven
- •4. Have an ECOG score of 0-1
- •5. Have an acceptable hematologic and coagulation status and kidney and liver functions at study entry
- •6. Be male or female and meet the following conditions:
- •a. Female participants must be of non-childbearing potential, or,
- •b. If of childbearing potential be non-pregnant or lactating and agree to use highly effective contraception from screening through Day 30.
- •c. 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 90 days post-dose and agree not to donate semen during this waiting period.
- •d.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 30.
- •7. Are judged to be an acceptable surgical risk by the operating surgeon and the anesthesiologist/anesthetist.
- •8. Have not participated in a clinical trial within the last 30 days.
排除标准
- •1. Have a history of myocardial infarction, cerebrovascular accident, uncontrolled congestive heart failure, significant liver disease, or unstable angina within 6 months prior to enrollment.
- •2. Have any other condition that causes the Investigator to deem them unfit for lung resection.
- •3. Are receiving a Class IA (i.e. quinidine, procainamide) or Class III (i.e. dofetilide, amiodarone, sotalol) antiarrhythmic agents
- •4. Have congenital long QT syndrome or QTcF > 450 ms (males) or >470 ms (females) by history or at Screening ECG.
- •5. Have a history or evidence of interstitial pneumonitis or pulmonary fibrosis
- •6. A known allergy or reaction to ICG or other radiographic contrast agents
- •7. Any other co-morbidity or habit that the Investigator believes will interfere with their ability to comply with and complete the study
研究者
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