Trial Outcomes & Findings for Phase 2 Study of VGT-309 in Lung Cancer (NCT NCT05400226)

Last Updated: 2024-10-17

Results Overview

Identification of the proportion of subjects with at least one CSE as defined by: A. Localization of a Pulmonary Nodule using VGT-309 near-infrared (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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Day of surgery

Results posted on

2024-10-17

Participant Flow

Participant milestones

Participant milestones
Measure	VGT-309 VGT-309 0.32mg/kg IV 12-36 hours pre surgery
Overall Study STARTED	40
Overall Study Dosing	40
Overall Study Surgery	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 2 Study of VGT-309 in Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VGT-309 0.32mg/kg n=40 Participants One-time dose by IV infusion over 15-20 minutes using a syringe pump between 12-36 hours prior to the start of surgery
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	27 Participants n=5 Participants
Age, Customized Age	66 years STANDARD_DEVIATION 10.51 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants
Height	165.33 cm STANDARD_DEVIATION 13.863 • n=5 Participants
Weight	77.61 kg STANDARD_DEVIATION 23.658 • n=5 Participants
Body Mass Index	28.62 kg/m^2 STANDARD_DEVIATION 9.349 • n=5 Participants

PRIMARY outcome

Timeframe: Day of surgery

Population: Efficacy Population: All subjects who received any amount of VGT-309 and had surgery with NIR imaging

Outcome measures

Outcome measures
Measure	VGT-309 0.32mg/kg IV Given 12-36 Hours Prior to Surgery n=40 Participants Subjects who received VGT-309 and underwent intraoperative NIR imaging.
Clinically Significant Event (CSE)	0.425 Proportion of subjects Interval 0.27 to 0.591

SECONDARY outcome

Timeframe: Day of surgery

Sensitivity is defined as the probability that tissue fluoresces intraoperatively when it is cancer as confirmed by histology. Sensitivity = (True Positive)/(True Positive + False Negative)

Outcome measures

Outcome measures
Measure	VGT-309 0.32mg/kg IV Given 12-36 Hours Prior to Surgery n=55 lesions Subjects who received VGT-309 and underwent intraoperative NIR imaging.
Sensitivity	0.850 Proportion of lesions Interval 0.675 to 0.939

SECONDARY outcome

Timeframe: Day of surgery

Population: Efficacy Population: All subjects who received any amount of VGT-309 and had surgery with NIR imaging

Negative predictive value is defined as the probability that a tissue sample does not contain cancer on histologic exam if it does not fluoresce intraoperatively. Negative Predictive Value = (True Negative)/(True Negative + False Negative)

Outcome measures

Outcome measures
Measure	VGT-309 0.32mg/kg IV Given 12-36 Hours Prior to Surgery n=55 lesions Subjects who received VGT-309 and underwent intraoperative NIR imaging.
Negative Predictive Value	0.455 Proportion of lesions Interval 0.202 to 0.733

SECONDARY outcome

Timeframe: Day of surgery

Population: Efficacy Population: All subjects who received any amount of VGT-309 and had surgery with NIR imaging

Specificity is defined as the probability that tissue does not fluoresce intraoperatively when it is not cancerous as confirmed by histology. Specificity = (True Negative)/(True Negative + False Positive)

Outcome measures

Outcome measures
Measure	VGT-309 0.32mg/kg IV Given 12-36 Hours Prior to Surgery n=55 lesions Subjects who received VGT-309 and underwent intraoperative NIR imaging.
Specificity	0.333 Proportion of lesions Interval 0.126 to 0.633

SECONDARY outcome

Timeframe: Day of surgery

Population: Efficacy Population: All subjects who received any amount of VGT-309 and had surgery with NIR imaging

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

Outcome measures

Outcome measures
Measure	VGT-309 0.32mg/kg IV Given 12-36 Hours Prior to Surgery n=55 lesions Subjects who received VGT-309 and underwent intraoperative NIR imaging.
Positive Predictive Value	0.773 Proportion of lesions Interval 0.65 to 0.862

Adverse Events

VGT-309 0.32mg/kg

Serious events: 8 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	VGT-309 0.32mg/kg n=40 participants at risk One-time dose by IV infusion over 15-20 minutes using a syringe pump between 12-36 hours prior to the start of surgery
Gastrointestinal disorders Ileus	2.5% 1/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Gastrointestinal disorders Vomiting	2.5% 1/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Metabolism and nutrition disorders Hypervolaemia	2.5% 1/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.5% 1/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Respiratory, thoracic and mediastinal disorders Pneumothorax	7.5% 3/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Respiratory, thoracic and mediastinal disorders Hypoxia	2.5% 1/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Injury, poisoning and procedural complications Traumatic haemothorax	2.5% 1/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) 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=40 participants at risk One-time dose by IV infusion over 15-20 minutes using a syringe pump between 12-36 hours prior to the start of surgery
Injury, poisoning and procedural complications Procedural pain	100.0% 40/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Respiratory, thoracic and mediastinal disorders Pneumothorax	62.5% 25/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Respiratory, thoracic and mediastinal disorders Dyspnoea	15.0% 6/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Respiratory, thoracic and mediastinal disorders Hypoxia	15.0% 6/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Respiratory, thoracic and mediastinal disorders Cough	10.0% 4/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.0% 2/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	5.0% 2/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Respiratory, thoracic and mediastinal disorders Wheezing	5.0% 2/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Vascular disorders Hypotension	42.5% 17/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Vascular disorders Hypertension	5.0% 2/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Cardiac disorders Sinus bradycardia	15.0% 6/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Cardiac disorders Supraventricular extrasystoles	10.0% 4/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Cardiac disorders Supraventricular tachycardia	7.5% 3/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Cardiac disorders Tachycardia	7.5% 3/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Cardiac disorders Atrial fibrillation	5.0% 2/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Gastrointestinal disorders Nausea	22.5% 9/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Gastrointestinal disorders Vomiting	12.5% 5/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Gastrointestinal disorders Constipation	5.0% 2/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Metabolism and nutrition disorders Hypomagnesaemia	12.5% 5/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Metabolism and nutrition disorders Hypokalaemia	7.5% 3/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Metabolism and nutrition disorders Hypocalcaemia	5.0% 2/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Investigations Aspartate aminotransferase increased	10.0% 4/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Investigations Amylase increased	5.0% 2/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Investigations Gamma-glutamyl transferase increased	5.0% 2/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Renal and urinary disorders Urinary retention	17.5% 7/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
General disorders Fatigue	5.0% 2/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Musculoskeletal and connective tissue disorders Arthralgia	7.5% 3/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Nervous system disorders Dizziness	5.0% 2/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Nervous system disorders Somnolence	5.0% 2/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Psychiatric disorders Hallucination	5.0% 2/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) ClinicalTrials.gov definition of "Adverse Events" was used for data collection and reporting
Skin and subcutaneous tissue disorders Subcutaneous emphysema	7.5% 3/40 • Adverse events were collected from the time of dosing through completion of the End-of-Study Visit (Days 22-36) 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