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VGT-309 Imaging Technique for Colorectal Cancer
Phase < 1
Recruiting
Led By Stephan Rogalla, M.D., PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Be at least 18 years of age
Must not have
Have congenital long QT syndrome or QTcF > 450ms (males) or >470ms (females) by history or at Screening ECG
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 days
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new substance called VGT-309 that helps doctors see colorectal tumors better during an endoscopy by making them glow under a special light. It targets patients with colorectal tumors to improve detection. The study also looks at various biomarkers in tumor samples.
Who is the study for?
Adults with confirmed colorectal adenocarcinoma who are scheduled for a standard colonoscopy can join. They must have good liver and kidney function, not be pregnant or breastfeeding, agree to use effective contraception, and have an ECOG score of 0-2. Those allergic to ICG or VGT-309 components, with certain heart conditions, or unable to consent cannot participate.
What is being tested?
The trial is testing the safety and effectiveness of VGT-309 as a fluorescent probe during augmented colonoscopy for real-time visualization of colorectal tumors using NIR fluorescence endoscopy. It also examines over 50 biomarkers in biopsies.
What are the potential side effects?
Potential side effects may include reactions related to the infusion of VGT-309 or allergies due to its components. The exact side effects are being studied as part of this trial's purpose.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a colonoscopy in the operating room before surgery or for restaging after treatment.
Select...
I am 18 years old or older.
Select...
I am using a form of hormonal birth control.
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I am able to get out of my bed or chair and move around.
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I have been diagnosed with colorectal cancer.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a long QT syndrome or my heart's electrical cycle is longer than normal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of VGT-309
Safety Profile of VGT309
Side effects data
From 2023 Phase 2 trial • 40 Patients • NCT05400226100%
Procedural pain
63%
Pneumothorax
43%
Hypotension
23%
Nausea
18%
Urinary retention
15%
Sinus bradycardia
15%
Dyspnoea
15%
Hypoxia
13%
Vomiting
13%
Hypomagnesaemia
10%
Aspartate aminotransferase increased
10%
Supraventricular extrasystoles
10%
Cough
8%
Hypokalaemia
8%
Supraventricular tachycardia
8%
Tachycardia
8%
Subcutaneous emphysema
8%
Arthralgia
5%
Oropharyngeal pain
5%
Fatigue
5%
Gamma-glutamyl transferase increased
5%
Wheezing
5%
Hypertension
5%
Atrial fibrillation
5%
Hypocalcaemia
5%
Pulmonary oedema
5%
Amylase increased
5%
Somnolence
5%
Constipation
5%
Dizziness
5%
Hallucination
3%
Traumatic haemothorax
3%
Hypervolaemia
3%
Ileus
3%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
VGT-309 0.32mg/kg
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: VGT-309Experimental Treatment1 Intervention
Subjects will receive an IV infusion of 0.32 mg/kg VGT-309 12 to 36 hours before a standard of care endoscopy procedure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VGT-309
2022
Completed Phase 2
~40
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for colorectal cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy drugs, such as fluorouracil and oxaliplatin, work by interfering with the DNA replication of cancer cells, leading to cell death.
Targeted therapies, like monoclonal antibodies (e.g., cetuximab and bevacizumab), inhibit specific molecules involved in tumor growth and angiogenesis. Immunotherapies, including bispecific antibodies like MGD007, engage the immune system to recognize and destroy cancer cells.
The development of near-infrared fluorescence probes like VGT-309 enhances tumor visualization during colonoscopy, allowing for more precise detection and removal of cancerous lesions. This matters for patients as it can lead to earlier diagnosis, more accurate treatment, and potentially better outcomes.
Colorectal Cancer: An Update on Treatment Options and Future Perspectives.Development of MGD007, a gpA33 x CD3-Bispecific DART Protein for T-Cell Immunotherapy of Metastatic Colorectal Cancer.Recent advances in targeted therapies for colorectal cancer.
Colorectal Cancer: An Update on Treatment Options and Future Perspectives.Development of MGD007, a gpA33 x CD3-Bispecific DART Protein for T-Cell Immunotherapy of Metastatic Colorectal Cancer.Recent advances in targeted therapies for colorectal cancer.
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,469 Previous Clinical Trials
17,501,732 Total Patients Enrolled
Stanford's Innovative Medicines AcceleratorUNKNOWN
Stephan Rogalla, M.D., PhDPrincipal InvestigatorStanford University
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