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Trial registered on ANZCTR


Registration number
ACTRN12621000301864
Ethics application status
Approved
Date submitted
20/01/2021
Date registered
18/03/2021
Date last updated
22/11/2024
Date data sharing statement initially provided
18/03/2021
Date results provided
31/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 2 Study to Evaluate the Dosing and Timing of VGT-309, a Tumor-Targeted Fluorescent Imaging Agent for the Identification of Lung Cancer
Scientific title
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
Secondary ID [1] 303125 0
Protocol VGT-309-2-2021AUS
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is a follow-on study to record ACTRN12620000948998

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 320229 0
Condition category
Condition code
Cancer 318165 318165 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 319424 0
Treatment: Other
Intervention code [2] 319769 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326151 0
Number of times the surgeon is able to visualize the tumour when using near-infrared fluorescence imaging with VGT-309
Timepoint [1] 326151 0
At the time of surgery
Primary outcome [2] 326152 0
To evaluate the safety of VGT-309 through the assessment of: treatment-emergent adverse events assessed through regular solicitation of subjects and review of physical examination data, vital sign data including blood pressure measured using a digital blood pressure monitor, heart rate measured as beats per minute, temperature and respiratory rate measured as breaths per minute, ECG data and clinical laboratory assessments of blood and urine: hematology (standard panel), coagulation (INR only), chemistry (standard panel including LFTs and amylase)
Timepoint [2] 326152 0
Treatment-emergent adverse events will be collected from the time of dosing on Day 1 through the Day 28 to Day 35 final safety follow-up visit
Physical examinations will be conducted at screening, on Day 1, Day 4, and Day 28-35
Clinical laboratory assessments of blood and urine will be collected at screening, on screening, on Day 1, Day 4, and Day 28-35
ECGs will be collected at screening, on Day 1, Day 4, and Day 28-35.
Vital signs will be collected at screening, on Day 1, at time of surgery on Day 1 or Day 2, Day 4, and Day 28-35.
Primary outcome [3] 326591 0
To determine the quality or intensity of the fluorescence of the visualised tumours when using near-infrared fluorescence imaging with VGT-309
Timepoint [3] 326591 0
At the time of surgery
Secondary outcome [1] 390257 0
Comparison of tumor-to-background ratio (TBR) in ex vivo surgical specimen(s) from subjects receiving 2 additional VGT-309 doses
Timepoint [1] 390257 0
At time of surgery
Secondary outcome [2] 390258 0
Proportion of subjects requiring VGT-309 and NIR imaging to detect a primary lung lesion that could not be detected after 5 minutes with standard surgical techniques
Timepoint [2] 390258 0
At time of surgery
Secondary outcome [3] 390259 0
Comparison of the estimated depth from the surface of the lung of CT- visible lesions to those detectable from the surface of the lung during use of VGT-309 NIR fluorescent imaging
Timepoint [3] 390259 0
At time of surgery
Secondary outcome [4] 390260 0
Comparison of the rate of positive tumor surgical margins detected by VGT-309 NIR fluorescence imaging to the rate by standard frozen section analysis
Timepoint [4] 390260 0
At the time of surgery
Secondary outcome [5] 390261 0
Comparison of the rate of positive tumor margins detected by VGT-309 NIR fluorescence imaging to the rate by standard formalin-fixed paraffin-embedded (FFPE) sampling
Timepoint [5] 390261 0
Within 24 hours post surgery
Secondary outcome [6] 421121 0
To investigate the influence, if any, of the higher doses, at peak serum concentration on the timing and morphology of the electrocardiogram.
Timepoint [6] 421121 0
Four blood samples to be taken immediately prior to dosing with VGT-309,
within 10 minutes of completion of dosing, 30 minutes after completion of
dosing and, when possible, within 60 minutes prior to the start of surgery.
(Refer to Schedule of Assessments for details)

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Other
Other design features
In the first part of the study, when subjects are deemed eligible for study entry, they were assigned to one of 4 cohorts.
Cohort 1: 6 patients assigned to 0.05 mg/kg, administered either 12-36 hours or 2-6 hours pre-operation
Cohort 2: 6 patients assigned to 0.16 mg/kg, administered either 12-36 hours or 2-6 hours pre-operation
Cohort 3: 6 patients assigned to 0.32 mg/kg, administered either 12-36 hours or 2-6 hours pre-operation
Cohort 4: subjects given the dose and dose timing identified as optimal.

Cohort 1-4 completed in May2022.

Cohort 5: 10 patients were assigned to 0.5 mg/kg, administered either 12-36 hours or 2-6 hours pre-operation
Cohort 6: 10 patients were assigned to 0.64 mg/kg, administered either 12-36 hours or 2-6 hours pre-operation

Cohort 7 will have 10 subjects assigned 0.32 mg/kg, administered intraperitoneally 36-96 hours preoperatively. Recruitment is scheduled to end in Dec2024
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is an early development study and therefore no formal sample size calculations were involved in the sample size determination.

Statistical analyses for both safety and efficacy will be primarily descriptive.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/05/2021
Actual
11/05/2021
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
13/02/2025
Actual
Sample size
Target
57
Accrual to date
50
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18379 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 18380 0
St Vincent's Private Hospital - Fitzroy
Recruitment hospital [3] 24591 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment postcode(s) [1] 32459 0
3065 - Fitzroy
Recruitment postcode(s) [2] 40186 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 307534 0
Commercial sector/Industry
Name [1] 307534 0
Vergent Bioscience Australia, Pty Ltd
Country [1] 307534 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Vergent Bioscience Australia, Pty Ltd
Address
c/o Case Governance Pty Ltd
Level 13
41 Exhibition Street
Melbourne, VIC, 3000
Country
Australia
Secondary sponsor category [1] 308212 0
None
Name [1] 308212 0
Address [1] 308212 0
Country [1] 308212 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307600 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 307600 0
Ethics committee country [1] 307600 0
Australia
Date submitted for ethics approval [1] 307600 0
01/03/2021
Approval date [1] 307600 0
27/04/2021
Ethics approval number [1] 307600 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53430 0
A/Prof Gavin Wright
Address 53430 0
Director of Surgical Oncology
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy, Victoria 3065
Country 53430 0
Australia
Phone 53430 0
+61 3 9419 2477
Fax 53430 0
Email 53430 0
gavin.wright@svha.org.au
Contact person for public queries
Name 53431 0
Gavin Wright
Address 53431 0
Director of Surgical Oncology
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy, Victoria 3065
Country 53431 0
Australia
Phone 53431 0
+61 3 9419 2477
Fax 53431 0
Email 53431 0
gavin.wright@svha.org.au
Contact person for scientific queries
Name 53432 0
Gavin Wright
Address 53432 0
Director of Surgical Oncology
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy, Victoria 3065
Country 53432 0
Australia
Phone 53432 0
+61 3 9419 2477
Fax 53432 0
Email 53432 0
gavin.wright@svha.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Information is not yet available


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AICathepsin detection to identify malignant cells during robotic pulmonary resection2023https://doi.org/10.21037/tlcr-23-370
Dimensions AIFluorescent Probes for Imaging in Humans: Where Are We Now?2023https://doi.org/10.1021/acsnano.3c03564
N.B. These documents automatically identified may not have been verified by the study sponsor.