ANZCTR - Registration

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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

21/04/2023

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]

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

Condition category

Condition code

Cancer

Lung - Non small cell

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Approximately 24 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 was enrolled in this study in 4 dose cohorts.

Subjects were sequentially assigned into one of four cohorts as detailed below. Within each of Cohorts 1 to 3, subjects were dosed either 12 to 36 hours or 2 to 6 hours before surgery depending on their admission to the hospital. The split into each of the dosing time windows was not be equal but best efforts will be made to ensure that a minimum of two subjects at each dose level are assigned to a dosing window. In Cohort 4, approximately 6 subjects were given the dose of VGT-309 and dose timing identified as the optimal dose that is safe and gives the best visualisation of the tumor.
VGT-309 was administered as a single intravenous infusion over 15 to 20 minutes. Doses of VGT-309 were administered in hospital under medical supervision.The doses for this study were:
Cohort 1: 0.05 mg/kg given either 12-36 hours pre-op or 2-6 hours pre-op
Cohort 2: 0.16 mg/kg given either 12-36 hours pre-op or 2-6 hours pre-op
Cohort 3: 0.32 mg/kg given either 12-36 hours pre-op or 2-6 hours pre-op
Cohort 4: Optimal dose defined in Cohort 1 as a safe dose that produces the best visualisation of the tumor.
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 is scheduled to commence Apr2023.
In Cohort 5 to 6 , approximately 20 subjects will be given the dose of VGT-309 and dose timing identified as the optimal dose that is safe and gives the best visualisation of the tumor.

The doses for this study are
Cohort 5: 0.5 mg/kg given either 12-36 hours pre-op or 2-6 hours pre-op
Cohort 6: 0.64 mg/kg given either 12-36 hours pre-op or 2-6 hours pre-op

Intervention code [1]

Treatment: Other

Intervention code [2]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Number of times the surgeon is able to visualize the tumour when using near-infrared fluorescence imaging with VGT-309

Timepoint [1]

At the time of surgery

Primary outcome [2]

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]

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]

To determine the quality or intensity of the fluorescence of the visualised tumours when using near-infrared fluorescence imaging with VGT-309

Timepoint [3]

At the time of surgery

Secondary outcome [1]

Comparison of tumor-to-background ratio (TBR) in ex vivo surgical specimen(s) from subjects receiving 2 additional VGT-309 doses

Timepoint [1]

At time of surgery

Secondary outcome [2]

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]

At time of surgery

Secondary outcome [3]

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]

At time of surgery

Secondary outcome [4]

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]

At the time of surgery

Secondary outcome [5]

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]

Within 24 hours post surgery

Secondary outcome [6]

To investigate the influence, if any, of the higher doses, at peak serum concentration on the timing and morphology of the electrocardiogram.

Timepoint [6]

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?

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

Open label ascending dose study.
When subjects are deemed eligible for study entry, they were assigned to one of 4 cohorts.
Cohort 1, 2, 3 had 6 subjects assigned to each cohort and 1 of 2 dosing time windows. Cohort 4 had approximately 6 subjects given the dose and dose timing identified as optimal. Cohort 1-4 completed in May2022.

Cohort 5 and 6 will have 10 subjects assigned to each dose and recruitment is scheduled to begin in Apr2023.

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

12/09/2023

Actual

Date of last data collection

Anticipated

16/10/2023

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment hospital [2]

St Vincent's Private Hospital - Fitzroy

Recruitment hospital [3]

Royal Melbourne Hospital - Royal Park campus - Parkville

Recruitment postcode(s) [1]

3065 - Fitzroy

Recruitment postcode(s) [2]

3052 - Parkville

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Vergent Bioscience Australia, Pty Ltd

Address [1]

c/o Case Governance Pty Ltd
Level 13
41 Exhibition Street
Melbourne, VIC, 3000

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent's Hospital Melbourne Human Research Ethics Committee

Ethics committee address [1]

Research Governance Unit
Level 5, Building E (Aikenhead Building)
27 Victoria Parade
Fitzroy VIC 3065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/03/2021

Approval date [1]

27/04/2021

Ethics approval number [1]

Summary

Brief summary

This study is to look at the efficacy and safety of VGT-309, a tumour targeted imaging agent, when used intra-operatively in subjects with scheduled surgical resection or biopsy of suspicious or proven lung cancer

Who is it for?
You may be eligible for this study if you are an adult man or woman at least 18 years of age and you are scheduled to undergo surgical resection or excisional biopsy (per standard of care) of a lung nodule that is suspicious for, or proven to be, lung cancer. 

Study details
If you meet the entry criteria you will be assigned to one of two dosing cohorts and will receive a single dose of VGT-309 which will be given to you as in intravenous infusion over a period of 15 to 20 minutes either 12-36 hours before your surgery or 2-6 hours before your surgery.  Total participation will last about 35 days (not including the 28 day screening period) and during this time for safety you will have blood and urine samples drawn, your vital signs will be checked, you will have physical examinations and ECGs will be conducted.

It is hoped this research will enable doctors in the future to use VGT-309 as an intraoperative fluorescent imaging agent to identify lung cancer compared to surrounding normal tissue

Trial website

https://www.vergentbio.com/

Trial related presentations / publications

Public notes

not available yet

Contacts

Principal investigator

Name

A/Prof Gavin Wright

Address

Director of Surgical Oncology
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy, Victoria 3065

Country

Australia

Phone

+61 3 9419 2477

Fax

[email protected]

Contact person for public queries

Name

Gavin Wright

Address

Director of Surgical Oncology
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy, Victoria 3065

Country

Australia

Phone

+61 3 9419 2477

Fax

[email protected]

Contact person for scientific queries

Name

Gavin Wright

Address

Director of Surgical Oncology
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy, Victoria 3065

Country

Australia

Phone

+61 3 9419 2477

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		VGT-309 was shown to be well-tolerated with few si... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Cathepsin detection to identify malignant cells during robotic pulmonary resection	2023	https://doi.org/10.21037/tlcr-23-370
Dimensions AI	Fluorescent Probes for Imaging in Humans: Where Are We Now?	2023	https://doi.org/10.1021/acsnano.3c03564

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically