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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06145048




Registration number
NCT06145048
Ethics application status
Date submitted
13/11/2023
Date registered
22/11/2023
Date last updated
28/03/2025

Titles & IDs
Public title
Phase 2B Safety and Efficacy Study of VGT-309 in Subjects With Cancer in the Lung.
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
Secondary ID [1] 0 0
VGT-309-2B-2023
Universal Trial Number (UTN)
Trial acronym
VISUALIZE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 0 0
Lung Metastases 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Measurements taken under SOC surgical procedures and under NIR imaging
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
During surgery and up to 1 month post-surgery
Secondary outcome [1] 0 0
Measurements taken under SOC surgical procedures and under NIR imaging
Assessment method [1] 0 0
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: 1. Sensitivity is defined as the probability that the tissue fluoresces when it is cancer, as confirmed by histology (TP/(TP+FN)) \* 2. Positive predictive value (PPV) is defined as the probability that a tissue sample contains cancer on histologic exam if it fluoresces ((TP/(TP+FP)) 3. 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
Timepoint [1] 0 0
During surgery and up to one month post-surgery

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.

-
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/02/2025
Sample size
Target
Accrual to date
Final
89
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Vergent Bioscience, Inc.
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Curtis Scribner, MD
Address 0 0
Vergent Bioscience
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Maggie M Neptune, B.S.
Address 0 0
Country 0 0
Phone 0 0
510-410-9124
Email 0 0
mneptune@vergentbio.com
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06145048