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

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

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.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: VGT-309

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

   1. ALT/AST < 1.5 times the upper limit of normal,
   2. Creatinine clearance (according to Cockcroft-Gault Equation) > 50 mL/min
   3. 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:

   1. Oral, injectable, implantable, intravaginal, or transdermal hormonal contraceptives, or
   2. 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:

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:

   1. ALT/AST < 1.5 times the upper limit of normal,
   2. Creatinine clearance (according to Cockcroft-Gault Equation) > 50 mL/min
   3. 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:

   1. Oral, injectable, implantable, intravaginal, or transdermal hormonal contraceptives, or
   2. 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. Class 2 or higher obesity, defined by BMI ≥ 35.0.
6. Have any other comorbidity or habit that the Investigator believes will interfere with their ability to comply with and complete the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VGT-309; Subjects will receive an IV infusion of 0.32 mg/kg VGT-309 12 to 36 hours before a standard of care endoscopy procedure.	Drug: VGT-309; 0.32mg/kg IV of VGT-309 given 12-36 hours before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	18 days
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.	18 days

Collaborators and Investigators

• Sponsor: Stephan Rogalla
• Collaborators: Stanford's Innovative Medicines Accelerator
• Investigators: Principal Investigator: Stephan Rogalla, M.D., PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2024
• Primary Completion (Actual): April 4, 2025
• Study Completion (Actual): April 4, 2025

Study Registration Dates

• First Submitted: September 5, 2023
• First Submitted That Met QC Criteria: September 5, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: IRB-68096; NCI-2024-01204 (Registry Identifier: National Cancer Institute Clinical Trials Reporting Program)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No