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

NCT06034197 | Terminated Early Phase 1 FDA Drug

• 2 other identifiers: IRB-68096NCI-2024-01204
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

VGT-309

EXPERIMENTAL

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

Interventions

VGT-309 DRUG

0.32mg/kg IV of VGT-309 given 12-36 hours before surgery

VGT-309

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with histologically confirmed distal colorectal adenocarcinoma of any stage.
• Be willing and able to sign the informed consent and comply with study procedures.
• 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
• Have acceptable kidney and liver functions at study entry as evidenced by:
• ALT/AST \< 1.5 times the upper limit of normal,
• Creatinine clearance (according to Cockcroft-Gault Equation) \> 50 mL/min
• Total bilirubin \< 1.5 times the upper limit of normal
• Have an ECOG score of 0-2.
• Be at least 18 years of age.
• 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
• 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.
• 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.

You may not qualify if:

• Adult patients with histologically confirmed distal colorectal adenocarcinoma of any stage.
• Be willing and able to sign the informed consent and comply with study procedures.
• 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
• Have acceptable kidney and liver functions at study entry as evidenced by:
• ALT/AST \< 1.5 times the upper limit of normal,
• Creatinine clearance (according to Cockcroft-Gault Equation) \> 50 mL/min
• Total bilirubin \< 1.5 times the upper limit of normal
• Have an ECOG score of 0-2.
• Be at least 18 years of age.
• 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
• 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.
• 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.
• Pregnant or breastfeeding females

Sponsors & Collaborators

• Stephan Rogalla: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Stephan Rogalla, M.D., PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor, Medicine - Gastroenterology & Hepatology

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: February 7, 2024
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: April 8, 2026

Record last verified: 2026-03

Locations

US (1)