None listed
Conditions
Brief summary
TThis study aims to evaluate the efficacy and safety of VGT-309, a tumor-targeted imaging agent, when used intraoperatively in subjects scheduled for surgical resection or biopsy of suspicious or confirmed lung cancer. Who is it for? This study is for adult men and women aged 18 years and older who are scheduled to undergo surgical resection or excisional biopsy (as per standard care) of a lung nodule that is suspicious for, or confirmed to be, lung cancer. Study Details Eligible subjects will receive a single intravenous infusion of VGT-309, administered 36-96 hours preoperatively. Total participation will last approximately 35 days (excluding a 28-day screening period). During this time, subjects will undergo safety monitoring, including blood and urine sample collections, vital sign checks, physical examinations, and ECGs. This research aims to enable doctors to use VGT-309 as an intraoperative fluorescent imaging agent to differentiate lung cancer from surrounding normal tissue in the future.
Interventions
Approximately 27 subjects scheduled for surgical resection or excisional biopsy of a lung nodule suspected of, or confirmed to be, lung cancer were enrolled in cohorts 1-4 during the first part of the study. An additional 30 patients were enrolled in cohorts 5-7 to determine the optimal dose and timing prior to surgery.
The dosing regimen for this study was as follows:
Cohort 1: 0.05 mg/kg, administered either 12-36 hours or 2-6 hours pre-operation
Cohort 2: 0.16 mg/kg, administered either 12-
Approximately 27 subjects scheduled for surgical resection or excisional biopsy of a lung nodule suspected of, or confirmed to be, lung cancer were enrolled in cohorts 1-4 during the first part of the study. An additional 30 patients were enrolled in cohorts 5-7 to determine the optimal dose and timing prior to surgery. The dosing regimen for this study was as follows: Cohort 1: 0.05 mg/kg, administered either 12-36 hours or 2-6 hours pre-operation Cohort 2: 0.16 mg/kg, administered either 12-36 hours or 2-6 hours pre-operation Cohort 3: 0.32 mg/kg, administered either 12-36 hours or 2-6 hours pre-operation Cohort 4: Optimal dose defined in Cohort 1 as the safest dose providing the best tumor visualization Cohort 5: 0.5 mg/kg, administered either 12-36 hours or 2-6 hours pre-operation Cohort 6: 0.64 mg/kg, administered either 12-36 hours or 2-6 hours pre-operation Cohort 7: 0.32 mg/kg, administered intraperitoneally 36-96 hours preoperatively. VGT-309 was given as a single intravenous infusion over 15 to 20 minutes, administered in a hospital setting under medical supervision. The recruitment for cohort 1-4 was completed in May2022. Additional 20 men or women who are scheduled to undergo surgical resection or excisional biopsy of a lung nodule that is suspicious for, or proven to be, lung cancer will now be enrolled in this study in the cohort 5 and 6 for extension phase 2 study. Recruitment for cohort 5 and 6 commenced Apr2023.
Sponsors
Vergent Bioscience Australia, Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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
Outcome results
None listed