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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06145048
Registration number
NCT06145048
Ethics application status
Date submitted
13/11/2023
Date registered
22/11/2023
Date last updated
24/01/2024
Titles & IDs
Public title
Phase 2B Safety and Efficacy Study of VGT-309 in Subjects With Cancer in the Lung.
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Scientific title
A Phase 2, Multi-center, Open-label Study to Evaluate the Safety and Efficacy of VGT-309, a Tumor-Targeted, Activatable Fluorescent Imaging Agent, in Subjects Undergoing Surgery for Cancer in the Lung
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Secondary ID [1]
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VGT-309-2B-2023
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Universal Trial Number (UTN)
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Trial acronym
VISUALIZE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lung Cancer
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Lung Metastases
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - VGT-309
Experimental: 0.32 mg/kg VGT-309 - 0.32 mg/kg VGT-309 given over 15-20 minutes by syringe pump
Treatment: Drugs: VGT-309
Intravenous drug to be given over 15-20 minutes by syringe pump.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Measurements taken under SOC surgical procedures and under NIR imaging
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Assessment method [1]
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Proportion of subjects with at least one Clinically Significant Event (CSE) defined as:
A. Intraoperative localization of one or more preoperatively identified lung lesions using VGT-309 with NIR imaging B. Identification of one or more synchronous or occult lung lesions using VGT-309 with NIR imaging when standard surgical techniques using white light and palpation and preoperative imaging failed to identify the lesion(s C. Identification of fluorescence within =10 mm from the inside edge of the closest staple line as measured by the investigator ex vivo in the operating room using NIR imaging, with pathologic margin confirmed by histologic examination to be = 10 mm.
D. Identification of lymph nodes by VGT-309 with NIR imaging confirmed by histologic examination to be cancerous.
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Timepoint [1]
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During surgery and up to 1 month post-surgery
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Secondary outcome [1]
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Measurements taken under SOC surgical procedures and under NIR imaging
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Assessment method [1]
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Efficacy: To evaluate the sensitivity, positive predictive value (PPV), and 1-PPV of VGT-309 with NIR imaging for lesion(s) in vivo. Definitions to apply:
Sensitivity is defined as the probability that the tissue fluoresces when it is cancer, as confirmed by histology (TP/(TP+FN)) *
Positive predictive value (PPV) is defined as the probability that a tissue sample contains cancer on histologic exam if it fluoresces ((TP/(TP+FP))
1-Positive predictive value (1-PPV) is defined as the probability that a tissue sample does not contain cancer when it fluoresces ((FP/(TP+FP))* Where: * TP = true positive, FP = false positive, FN = false negative
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Timepoint [1]
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During surgery and up to one month post-surgery
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Eligibility
Key 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. 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 30 after treatment.
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 after treatment 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: Subjects 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 after treatment.
Note: Subjects in a same sex relationship, must use a barrier form of contraception
(e.g., condom, diaphragm) to protect against the transfer of the study drug in any
bodily fluids.
4. Have a lung nodule or mass that might be considered primary lung cancer or lung
metastases whether or not it is biopsy-proven before surgery.
5. Be scheduled to undergo standard of care surgical resection for a lung nodule or mass
with diagnostic and/or curative intent
6. Have acceptable kidney and liver functions at study entry as evidenced by:
ALT/AST < 1.5 times the upper limit of normal Calculated Creatinine Clearance (CrCl) = 50
ml/min Total bilirubin < 1.5 times the upper limit of normal Have an ECOG score of 0-2.
Meet all standard of care surgical and general anesthesia requirements. 7) Have not
participated in an interventional clinical trial within the last 30 days.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Not a candidate for standard of care surgery based on opinion of the surgeon,
anesthesiologist, or other consulting physician.
2. Have a known allergy or reaction to ICG, other radiographic contrast agent, or any
component of VGT-309.
3. Have congenital long QT syndrome or QTcF > 470ms by history or at Screening ECG.
4. Prisoners, institutionalized individuals, or are unable to consent for themselves.
5. Have any other co-morbidity or habit that the Investigator believes will interfere
with their ability to comply with and complete the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/10/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2024
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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St. Vincent's Hospital - Melbourne
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Recruitment postcode(s) [1]
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3065 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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United States of America
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State/province [2]
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Minnesota
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Country [3]
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United States of America
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State/province [3]
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Pennsylvania
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Country [4]
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United States of America
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State/province [4]
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Texas
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Vergent Bioscience, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase 2, multi-center, open-label study to evaluate the safety and efficacy of
VGT-309, a tumor-targeted, activatable fluorescent imaging agent, in subjects undergoing
surgery for proven or suspected cancer in the lung. Approximately 100 subjects will be
enrolled to ensure at least 86 subjects are evaluable with the option to expand enrollment by
protocol amendment if deemed necessary by the DSC to meet primary and/or secondary
objectives.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06145048
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Curtis Scribner, MD
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Address
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Vergent Bioscience
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Maggie M Neptune, B.S.
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Address
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Country
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Phone
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510-410-9124
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06145048
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