Phase 2 Study of VGT-309 in Lung Cancer

Study Overview
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Brief Summary
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A Phase 2 open label study to evaluate safety and efficacy of VGT-309 to identify cancer in up to 40 subjects undergoing lung cancer surgery.

Detailed Description
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A Phase 2, open-label study to evaluate the safety and efficacy of VGT-309, a tumor-targeted, activatable fluorescent imaging agent, to identify cancer in subjects undergoing lung cancer surgery. A total of 40 subjects will be enrolled to ensure at least 38 evaluable subjects with the option to expand enrollment by protocol amendment if deemed necessary to meet primary and/or secondary objectives. Following agreement with and signing of the informed consent, subjects will undergo screening measurements for the study. Assessments include the following, unless they have been done within 4 weeks prior to the anticipated dosing: Medical, surgical and medication history. Complete physical exam, including vital signs and weight. Standard pre-operative chemistry, hematology, coagulation and urinalysis clinical laboratory studies. 12-lead ECG. Serum pregnancy test for females of child-bearing potential. Following clearance of all enrollment criteria, each subject will receive an IV administration of 0.32 mg/kg VGT-309 at 12-36 hours prior to surgery (refer to section VGT-309 Dosing, below). Upon dosing, subjects will be observed for up to 2 hours and asked about possible treatment emergent adverse events. Subjects will undergo surgical resection as planned and within the time specified following VGT-309 dosing. Measurements of efficacy will be taken during surgery and during the pathological examination of all surgical specimens. Following surgery, subjects will be monitored for safety during their hospitalization. After discharge from the hospital, and approximately 14 days post-surgery, the subjects will be contacted by telephone to assess their well-being. Between 19 to 39 days post-surgery, subjects will either return to the clinic or participate in a telehealth visit for final safety assessments. If there are no adverse events requiring further follow up, subjects will then be released from the study.

Official Title
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A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of VGT-309, a Tumor-Targeted, Activatable Fluorescent Imaging Agent, to Identify Cancer in Subjects Undergoing Lung Cancer Surgery

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: VGT-309


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be willing and able to sign the informed consent and comply with study procedures. Be between the ages of 18 and 85, inclusive. Be male or female and 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. 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 post-dose 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: 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. Have a lung nodule or mass that might be considered primary lung cancer or lung metastases, whether or not it is biopsyproven. Be scheduled to undergo standard of care surgical resection for a lung nodule or mass with diagnostic and/or curative intent and meet all pre-operative surgical and anesthesia acceptance criteria. Have acceptable kidney and liver functions at study entry as evidenced by: ALT/AST < 1.5 times the upper limit of normal Serum creatinine < 1.5 times the upper limit of normal Have an ECOG score of 0-2. Meet all standard surgical and general anesthesia requirements. Have not participated in a clinical trial within the last 30 days. Exclusion Criteria: They are not a candidate for standard of care surgery based on opinion of the surgeon, anesthesiologist, or other consulting physician. They have a known allergy or reaction to ICG, other radiographic contrast agent, or any component of VGT-309. Have congenital long QT syndrome or QTcF > 450ms (males) or >470ms (females) by history or at Screening ECG. They are prisoners, institutionalized individuals, or are unable to consent for themselves. Have any other co-morbidity or habit that the Investigator believes will interfere with their ability to comply with and complete the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All subjects to be dosed at the same dose level. This is open label and no randomization is required.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.32mg/kg VGT-309<br>Single arm in an open label study | Drug: VGT-309<br>* VGT-309 is an tumor-targeted, activatable fluorescent imaging agent which will be used with near infrared imaging during surgery to identify tumor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with at least one Clinically Significant Event (CSE) | Clinically significant events are defined as: Localization of a Pulmonary Nodule using VGT-309 NIR Imaging when white light and palpation failed to identify a nodule. B. Synchronous Lesion Identification using VGT-309 NIR Imaging when not identified by white light and palpation. C. Positive Margin Identification with only VGT-309 NIR Imaging when deemed negative by the surgeon by white light and palpation. | During surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value of VGT-309 | Sensitivity is defined as the probability that the tissue fluoresces when it is cancer, as confirmed by histology (TP/(TP+FN)) * Specificity is defined as the probability that the tissue does not fluoresce when it is not cancerous as confirmed by histology (TN/(TN+FP)) * Positive predictive value (PPV) is defined as the probability that a tissue sample contains cancer on histologic exam if it fluoresces (TP/(TP+FP)) * Negative predictive value (NPV) is defined as the probability that the tissue sample does not contain cancer on histologic exam if it does not fluoresce (TN/(TN+FN)) * | during surgery |