Phase 2B Safety and Efficacy Study of VGT-309 in Subjects With Cancer in the Lung. (VISUALIZE)

• ClinicalTrials.gov Identifier: NCT06145048
• Recruitment Status: Recruiting
• First Posted: November 22, 2023
• Last Update Posted: January 24, 2024
• Sponsor: Vergent Bioscience, Inc.
• Information provided by (Responsible Party): Vergent Bioscience, Inc.

Tracking Information

• First Submitted Date: November 13, 2023
• First Posted Date: November 22, 2023
• Last Update Posted Date: January 24, 2024
• Actual Study Start Date: October 5, 2023
• Estimated Primary Completion Date: July 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 17, 2023)

Measurements taken under SOC surgical procedures and under NIR imaging [ Time Frame: During surgery and up to 1 month post-surgery ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 17, 2023)

Measurements taken under SOC surgical procedures and under NIR imaging [ Time Frame: During surgery and up to one month post-surgery ]

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Phase 2B Safety and Efficacy Study of VGT-309 in Subjects With Cancer in the Lung.
• Official 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
• 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.

Detailed Description

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.

Following agreement with and signing of the informed consent, subjects will undergo screening measurements for the study within 4 weeks prior to the anticipated dosing:

1. Medical, surgical and medication history.
2. Complete physical exam, including vital signs and height
3. Weight (needed for dose calculation)
4. Chemistry, hematology, coagulation and urinalysis with microscopy clinical laboratory studies.
5. 12-lead ECG.
6. Serum pregnancy test for females of child-bearing potential.

After meeting all enrollment criteria, each subject will receive 0.32 mg/kg VGT-309 by IV administration 12-36 hours prior to surgery (refer to section VGT-309 Dosing, below). Subjects will be observed for 1 hour after dosing is completed and asked about possible treatment emergent adverse events.

Subjects will undergo surgical resection within 12-36 hours after completion of VGT-309 dosing. Measurements of efficacy will be taken during surgery and during the pathological examination of all surgical specimens. (Refer to Efficacy Endpoints and Efficacy Assessments sections).

Following surgery, subjects will be monitored for safety during their hospitalization. Between 7 to 14 and 25 to 35 days after surgery, the subjects will return to the clinic or have a telehealth visit for final safety assessments. At the last visit, if there are no adverse events requiring further follow up, subjects will then be released from the study.

• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

This is an open label study in which all subjects will receive a dose of 0.32mg/kg VGT-309 (based on their weight) at 12-36 hours pre-surgery.

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Lung Cancer
• Lung Metastases

Intervention

Drug: VGT-309

Intravenous drug to be given over 15-20 minutes by syringe pump.

Study Arms

Experimental: 0.32 mg/kg VGT-309

0.32 mg/kg VGT-309 given over 15-20 minutes by syringe pump

Intervention: Drug: VGT-309

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 17, 2023): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 2024
• Estimated Primary Completion Date: July 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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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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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Maggie M Neptune, B.S.; 510-410-9124; mneptune@vergentbio.com

Contact: Eric Bensen, Ph.D.; 952-479-7496; ebensen@vergentbio.com

• Listed Location Countries: Australia, United States

Administrative Information

• NCT Number: NCT06145048
• Other Study ID Numbers: VGT-309-2B-2023
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: The joint publication will be coordinated by Vergent. There is no need for individual sites to review specific IPD from other sites.

• Current Responsible Party: Vergent Bioscience, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Vergent Bioscience, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Curtis Scribner, MD; Vergent Bioscience

• PRS Account: Vergent Bioscience, Inc.
• Verification Date: January 2024