Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06145048
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2023-11-13
Brief Title:
Phase 2B Safety and Efficacy Study of VGT-309 in Subjects With Cancer in the Lung
Sponsor:
Vergent Bioscience Inc
Organization:
Vergent Bioscience Inc
Study Overview
Official Title:
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 Cancer in the Lung
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VISUALIZE
Brief Summary:
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 andor secondary objectives
Detailed Description:
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 andor 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 032 mgkg 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
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 032 mgkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None