VGT-309 Imaging Agent for Lung Cancer Detection
(VISUALIZE Trial)

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Vergent Bioscience, Inc.

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults with suspected or confirmed lung cancer who are fit for surgery and have not been in another clinical trial in the last month. They must be able to consent, have good kidney and liver function, an ECOG score of 0-2, meet surgical requirements, and follow contraception guidelines.

Inclusion Criteria

Have not participated in an interventional clinical trial within the last 30 days

My kidney and liver are functioning well.

I am able to get out of my bed or chair and move around.

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Exclusion Criteria

I have a long QT syndrome or my heart's electrical cycle is longer than normal.

You are allergic to ICG, other contrast agents used in imaging, or any part of VGT-309.

I have been advised against standard surgery by my healthcare team.

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Treatment Details

Interventions

VGT-309 (Cancer Imaging Agent)

Trial OverviewThe study tests VGT-309's safety and effectiveness. It's a fluorescent imaging agent used during lung cancer surgery to help identify tumors. The open-label Phase 2 trial will enroll around 100 subjects to ensure at least 86 evaluable participants.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: 0.32 mg/kg VGT-309Experimental Treatment1 Intervention

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