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Fluorescent Probe VGT-309 to ID Cancerous Colorectal Lesions During Augmented Colonoscopy

Primary Purpose

Colorectal Cancer

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
VGT-309
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1. Adult patients with histologically confirmed distal colorectal adenocarcinoma of any stage. 2. Be willing and able to sign the informed consent and comply with study procedures. 3. Are scheduled to undergo a SOC colonoscopy for restaging following radiochemotherapy or are scheduled to receive a SOC colonoscopy in the OR prior to resection 4. Have acceptable kidney and liver functions at study entry as evidenced by: a. ALT/AST < 1.5 times the upper limit of normal, b. Creatinine clearance (according to Cockcroft-Gault Equation) > 50 mL/min c. Total bilirubin < 1.5 times the upper limit of normal 5. Have an ECOG score of 0-2. 6. Be at least 18 years of age. 7. Female participants must be of non-childbearing potential, or, if of childbearing potential be non-pregnant or lactating and agree to use highly effective contraception from screening through 30 days after probe infusion 8. Male participants, if not surgically sterilized, and if engaging in sexual intercourse with a female partner of childbearing potential, must be willing to use highly effective contraception from screening through 30 days post-dose and agree not to donate semen during this waiting period. 9. Highly effective contraception involves the use of a condom for the male, plus one of the following for the female: Oral, injectable, implantable, intravaginal, or transdermal hormonal contraceptives, or Intrauterine device or intrauterine hormone-releasing system. NOTE: Participants who abstain from heterosexual intercourse as their usual and preferred lifestyle, will not be required to use contraception as described above. They are required to maintain abstinence from screening through Day 30, AND Participants in a same sex relationship, must use a barrier form of contraception (e.g., condom, diaphragm) to protect against the transfer of the study drug in any bodily fluids. Exclusion Criteria: 1. Pregnant or breastfeeding females 2. They have a known allergy or reaction to ICG, other radiographic contrast agents, or any component of VGT-309. 3. Have congenital long QT syndrome or QTcF > 450ms (males) or >470ms (females) by history or at Screening ECG. 4. They are prisoners, institutionalized individuals, or are unable to consent for themselves. 5. Have any other comorbidity or habit that the Investigator believes will interfere with their ability to comply with and complete the study.

Sites / Locations

  • Stanford UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VGT-309

Arm Description

Subjects will receive an IV infusion of 0.32 mg/kg VGT-309 12 to 36 hours before a standard of care endoscopy procedure.

Outcomes

Primary Outcome Measures

Safety Profile of VGT309
Safety profile will be measured by assessing number of Grade 2 or higher adverse events which have been determined to be clinically significant and definitely, probably or possibly related.
Feasibility of VGT-309
Feasibility to visualize colorectal tumors using NIR-endoscopy will be measured by the tumor-to-background ratio (fluorescence intensity of tumor tissue divided by the fluorescence intensity of normal surrounding tissue) and the concordance between white-light endoscopy assessment, histopathological examination and NIR imaging assessment.

Secondary Outcome Measures

Full Information

First Posted
September 5, 2023
Last Updated
October 6, 2023
Sponsor
Stanford University
Collaborators
Stanford's Innovative Medicines Accelerator
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1. Study Identification

Unique Protocol Identification Number
NCT06034197
Brief Title
Fluorescent Probe VGT-309 to ID Cancerous Colorectal Lesions During Augmented Colonoscopy
Official Title
Pilot Open Label Study to Determine the Safety and Efficacy of Fluorescent Probe, VGT-309, to Identify Cancerous Colorectal Lesions During White-Light and Fluorescence Augmented Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
Collaborators
Stanford's Innovative Medicines Accelerator

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to determine the safety and feasibility of VGT-309 for the visualization of colorectal tumors in real-time using near-infrared (NIR) fluorescence endoscopy. In addition, signatures of 50+ biomarkers will be evaluated in biopsies using CODEX multi-plexing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VGT-309
Arm Type
Experimental
Arm Description
Subjects will receive an IV infusion of 0.32 mg/kg VGT-309 12 to 36 hours before a standard of care endoscopy procedure.
Intervention Type
Drug
Intervention Name(s)
VGT-309
Intervention Description
0.32mg/kg IV of VGT-309 given 12-36 hours before surgery
Primary Outcome Measure Information:
Title
Safety Profile of VGT309
Description
Safety profile will be measured by assessing number of Grade 2 or higher adverse events which have been determined to be clinically significant and definitely, probably or possibly related.
Time Frame
18 days
Title
Feasibility of VGT-309
Description
Feasibility to visualize colorectal tumors using NIR-endoscopy will be measured by the tumor-to-background ratio (fluorescence intensity of tumor tissue divided by the fluorescence intensity of normal surrounding tissue) and the concordance between white-light endoscopy assessment, histopathological examination and NIR imaging assessment.
Time Frame
18 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Adult patients with histologically confirmed distal colorectal adenocarcinoma of any stage. 2. Be willing and able to sign the informed consent and comply with study procedures. 3. Are scheduled to undergo a SOC colonoscopy for restaging following radiochemotherapy or are scheduled to receive a SOC colonoscopy in the OR prior to resection 4. Have acceptable kidney and liver functions at study entry as evidenced by: a. ALT/AST < 1.5 times the upper limit of normal, b. Creatinine clearance (according to Cockcroft-Gault Equation) > 50 mL/min c. Total bilirubin < 1.5 times the upper limit of normal 5. Have an ECOG score of 0-2. 6. Be at least 18 years of age. 7. Female participants must be of non-childbearing potential, or, if of childbearing potential be non-pregnant or lactating and agree to use highly effective contraception from screening through 30 days after probe infusion 8. Male participants, if not surgically sterilized, and if engaging in sexual intercourse with a female partner of childbearing potential, must be willing to use highly effective contraception from screening through 30 days post-dose and agree not to donate semen during this waiting period. 9. Highly effective contraception involves the use of a condom for the male, plus one of the following for the female: Oral, injectable, implantable, intravaginal, or transdermal hormonal contraceptives, or Intrauterine device or intrauterine hormone-releasing system. NOTE: Participants who abstain from heterosexual intercourse as their usual and preferred lifestyle, will not be required to use contraception as described above. They are required to maintain abstinence from screening through Day 30, AND Participants in a same sex relationship, must use a barrier form of contraception (e.g., condom, diaphragm) to protect against the transfer of the study drug in any bodily fluids. Exclusion Criteria: 1. Pregnant or breastfeeding females 2. They have a known allergy or reaction to ICG, other radiographic contrast agents, or any component of VGT-309. 3. Have congenital long QT syndrome or QTcF > 450ms (males) or >470ms (females) by history or at Screening ECG. 4. They are prisoners, institutionalized individuals, or are unable to consent for themselves. 5. Have any other comorbidity or habit that the Investigator believes will interfere with their ability to comply with and complete the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joaquin Tabera
Phone
831-710-7387
Email
jtabera7@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Marissa N Dobry
Phone
313-320-2240
Email
mdobry@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Rogalla, M.D., PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joaquin Tabera
Email
jtabera7@stanford.edu
First Name & Middle Initial & Last Name & Degree
Erqi L Pollom, MD
First Name & Middle Initial & Last Name & Degree
Shai Friedland, MD
First Name & Middle Initial & Last Name & Degree
George A Fisher, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Fluorescent Probe VGT-309 to ID Cancerous Colorectal Lesions During Augmented Colonoscopy

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