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Phase 2B Safety and Efficacy Study of VGT-309 in Subjects With Cancer in the Lung.
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-10-05
Primary completion: 2024-07-01
Study completion finish: 2024-08-01
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT06145048
Intervention or treatment
DRUG: VGT-309
Conditions
- • Lung Cancer
- • Lung Metastases
Find a site
Closest Location:
St. Vincent's Hospital
Research sites nearby
Select from list below to view details:
St. Vincent's Hospital
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: 0.32 mg/kg VGT-309
| DRUG: VGT-309
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Measurements taken under SOC surgical procedures and under NIR imaging | 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. | During surgery and up to 1 month post-surgery |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Measurements taken under SOC surgical procedures and under NIR imaging | 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 | During surgery and up to one month post-surgery |
Frequently Asked Questions
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