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.
Additional locations may be listed on ClinicalTrials.gov for NCT06145048.
See trial information on ClinicalTrials.gov for a list of participating sites.
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.
Lead OrganizationVergent Bioscience, Inc.
Principal InvestigatorCurtis Scribne
