Trial Outcomes & Findings for Phase 2B Safety and Efficacy Study of VGT-309 in Subjects With Cancer in the Lung. (NCT NCT06145048)

Last Updated: 2026-05-13

Results Overview

Proportion of subjects with at least one Clinically Significant Event (CSE) as defined by: A. Intraoperative localization of one or more preoperatively identified lung lesions using VGT-309 with NIR imaging not found w/SOC; and confirmed by histologic examination to be other than normal lung tissue. B. Identification of one or more synchronous or occult lung lesions using VGT-309 with NIR imaging not found with SOC; and confirmed by histologic examination to be cancerous or precancerous. 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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

89 participants

Primary outcome timeframe

Day of surgery

Results posted on

2026-05-13

Participant Flow

Participants were recruited by the Cardiothoracic surgeons acting as Principal Investigators. They were offered participation in the trial if they met basic criteria for known or suspected cancer in the lung and the PI believed they were sufficiently healthy to undergo the planned anesthesia. 105 subjects were consented and 89 received the study drug and underwent planned surgery for removal of a lesion or lesions seen on pre-operative CT and thought to be cancer in the lung.

105 subjects were consented and screened, 16 subjects failed screening and were not considered to be enrolled. The remaining 89 subjects were marked as enrolled in the EDC and received study drug. This is different that the description in the Study Design section of the protocol where all consented were to be defined as enrolled. Programming of the EDC followed certain requirements and the difference between the protocol definition and the resulting assignment was not noted until now.

Participant milestones

Participant milestones
Measure	VGT-309 0.32mg/kg VGT-309 0.32mg/kg IV 12-36 hours pre surgery
Overall Study STARTED	89
Overall Study Dosing	89
Overall Study Surgery	89
Overall Study COMPLETED	88
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	VGT-309 0.32mg/kg VGT-309 0.32mg/kg IV 12-36 hours pre surgery
Overall Study Lost to Follow-up	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VGT-309 0.32mg/kg n=89 Participants VGT-309 0.32mg/kg IV 12-36 hours pre surgery
Age, Categorical <=18 years	1 Participants n=1512 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=1512 Participants
Age, Categorical >=65 years	65 Participants n=1512 Participants
Age, Customized Age	66.9 years STANDARD_DEVIATION 10.66 • n=1512 Participants
Sex: Female, Male Female	57 Participants n=1512 Participants
Sex: Female, Male Male	32 Participants n=1512 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=1512 Participants
Race (NIH/OMB) Asian	10 Participants n=1512 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=1512 Participants
Race (NIH/OMB) Black or African American	4 Participants n=1512 Participants
Race (NIH/OMB) White	70 Participants n=1512 Participants
Race (NIH/OMB) More than one race	0 Participants n=1512 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=1512 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=1512 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	77 Participants n=1512 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=1512 Participants
Region of Enrollment United States	71 participants n=1512 Participants
Region of Enrollment Australia	18 participants n=1512 Participants
Height	167.16 cm STANDARD_DEVIATION 9.681 • n=1512 Participants
Weight	78.79 kg STANDARD_DEVIATION 20.232 • n=1512 Participants
Body Mass Index	28.08 kg/m^2 STANDARD_DEVIATION 6.611 • n=1512 Participants
Smoking History Current	11 Participants n=1512 Participants
Smoking History Previous	45 Participants n=1512 Participants
Smoking History Never	33 Participants n=1512 Participants
Smoking History Missing	0 Participants n=1512 Participants
Packs Smoked Per Day	0.909 packs STANDARD_DEVIATION 0.4281 • n=1512 Participants
Years of Smoking	32.3 years STANDARD_DEVIATION 16.36 • n=1512 Participants
Pack Years	29.985 pack years STANDARD_DEVIATION 20.8719 • n=1512 Participants

PRIMARY outcome

Timeframe: Day of surgery

Population: Intent to Treat Population: all patients who received any amount of VGT-309 and had surgery with NIR imaging after the surgeon first attempted to locate the tumor/nodule by white light and/or palpation

Outcome measures

Outcome measures
Measure	VGT-309 0.32 mg/kg IV Given 12-36 Hours Prior to Surgery n=89 Participants Subjects who received VGT-309 and underwent intraoperative NIR imaging
Clinically Significant Events (CSE)	0.449 Proportion of subjects Interval 0.344 to 0.559

SECONDARY outcome

Timeframe: Day of Surgery

1 - Positive predictive value (1 - PPV) is defined as the probability that a tissue sample does not contain cancer when it fluoresces in vivo. 1 - PPV = (False Positives) / (True Positives + False Positives)

Outcome measures

Outcome measures
Measure	VGT-309 0.32 mg/kg IV Given 12-36 Hours Prior to Surgery n=141 Lesions Subjects who received VGT-309 and underwent intraoperative NIR imaging
1 - Positive Predictive Value	0.250 Proportion of lesions Interval 0.184 to 0.33

SECONDARY outcome

Timeframe: Day of Surgery

Positive predictive value (PPV) is defined as the probability that a tissue sample contains cancer on histologic exam if it fluoresces in vivo. PPV = (True Positives) / (True Positives + False Positives)

Outcome measures

Outcome measures
Measure	VGT-309 0.32 mg/kg IV Given 12-36 Hours Prior to Surgery n=141 Lesions Subjects who received VGT-309 and underwent intraoperative NIR imaging
Positive Predictive Value	0.750 Proportion of lesions Interval 0.67 to 0.816

SECONDARY outcome

Timeframe: Day of Surgery

Sensitivity is defined as the probability that the tissue fluoresces in vivo when it is cancer, as confirmed by histology. Sensitivity = (True Positives) / (True Positives + False Negatives

Outcome measures

Outcome measures
Measure	VGT-309 0.32 mg/kg IV Given 12-36 Hours Prior to Surgery n=141 Lesions Subjects who received VGT-309 and underwent intraoperative NIR imaging
Sensitivity	0.841 Proportion of lesions Interval 0.757 to 0.9

Adverse Events

VGT-309 0.32mg/kg

Serious events: 12 serious events

Other events: 89 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	VGT-309 0.32mg/kg n=89 participants at risk VGT-309 0.32mg/kg IV 12-36 hours pre surgery
Skin and subcutaneous tissue disorders Subcutaneous emphysema	2.2% 2/89 • Number of events 2 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Metabolism and nutrition disorders Hyperglycaemia	1.1% 1/89 • Number of events 1 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Respiratory, thoracic and mediastinal disorders Pneumothorax	3.4% 3/89 • Number of events 3 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.1% 1/89 • Number of events 1 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Respiratory, thoracic and mediastinal disorders Pulmonary air leakage	2.2% 2/89 • Number of events 2 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Cardiac disorders Atrial fibrillation	2.2% 2/89 • Number of events 2 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Cardiac disorders Cardiac failure	1.1% 1/89 • Number of events 1 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Renal and urinary disorders Acute kidney injury	1.1% 1/89 • Number of events 1 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Nervous system disorders Encephalopathy	1.1% 1/89 • Number of events 1 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Nervous system disorders Ataxia	1.1% 1/89 • Number of events 1 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Hepatobiliary disorders Ataxia	1.1% 1/89 • Number of events 1 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Investigations Alanine aminotransferase increased	1.1% 1/89 • Number of events 1 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Investigations Aspartate aminotransferase increased	1.1% 1/89 • Number of events 1 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Infections and infestations Metapneumovirus infection	1.1% 1/89 • Number of events 1 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Infections and infestations Lower respiratory tract infection	1.1% 1/89 • Number of events 1 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting

Other adverse events

Other adverse events
Measure	VGT-309 0.32mg/kg n=89 participants at risk VGT-309 0.32mg/kg IV 12-36 hours pre surgery
Injury, poisoning and procedural complications Procedural Pain	100.0% 89/89 • Number of events 89 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Respiratory, thoracic and mediastinal disorders Cough	22.5% 20/89 • Number of events 20 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Respiratory, thoracic and mediastinal disorders Dyspnoea	14.6% 13/89 • Number of events 13 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Respiratory, thoracic and mediastinal disorders Pneumothorax	10.1% 9/89 • Number of events 9 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	4.5% 4/89 • Number of events 4 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Respiratory, thoracic and mediastinal disorders Haemoptysis	4.5% 4/89 • Number of events 4 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Respiratory, thoracic and mediastinal disorders Pulmonary air leakage	4.5% 4/89 • Number of events 4 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Respiratory, thoracic and mediastinal disorders Wheezing	4.5% 4/89 • Number of events 4 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Gastrointestinal disorders Nausea	19.1% 17/89 • Number of events 17 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Gastrointestinal disorders Abdominal distension	7.9% 7/89 • Number of events 7 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Gastrointestinal disorders Constipation	7.9% 7/89 • Number of events 7 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Gastrointestinal disorders Vomiting	7.9% 7/89 • Number of events 7 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Nervous system disorders Dizziness	5.6% 5/89 • Number of events 5 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Nervous system disorders Headache	5.6% 5/89 • Number of events 5 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Musculoskeletal and connective tissue disorders Muscle spasms	9.0% 8/89 • Number of events 8 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Musculoskeletal and connective tissue disorders Arthralgia	4.5% 4/89 • Number of events 4 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
General disorders Fatigue	10.1% 9/89 • Number of events 9 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Metabolism and nutrition disorders Hypomagnesemia	5.6% 5/89 • Number of events 5 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Vascular disorders Hypotension	6.7% 6/89 • Number of events 6 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Vascular disorders Hypertension	7.9% 7/89 • Number of events 7 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Investigations Aspartate aminotransferase increased	5.6% 5/89 • Number of events 5 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Skin and subcutaneous tissue disorders Pruritis	4.5% 4/89 • Number of events 4 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Skin and subcutaneous tissue disorders Subcutaneous emphysema	4.5% 4/89 • Number of events 4 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Cardiac disorders Atrial fibrillation	5.6% 5/89 • Number of events 5 • Time of dosing through completion of the End-of-Study Visit (Days 25-35). ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting

Additional Information

Maggie Neptune

Vergent Bio

Phone: +1-510-410-9124

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60