What side effects are associated with this type of intervention?

Common treatments for colorectal cancer include chemotherapy, targeted therapy, and newer techniques like near-infrared fluorescence for tumor visualization. Chemotherapy often involves drugs like 5-fluorouracil and can cause side effects such as myelosuppression, stomatitis, nausea, vomiting, diarrhea, and cutaneous problems. Targeted therapies, such as those involving epidermal growth factor receptor inhibitors, can lead to ocular toxicities, including keratitis and uveitis. For treatments similar to VGT-309, which use near-infrared fluorescence, the primary concerns are related to the safety and feasibility of the procedure, with potential risks including allergic reactions to the fluorescent tracers.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of colorectal cancer, including panitumumab (Vectibix) and bevacizumab. Panitumumab is approved for patients with EGFR-expressing metastatic colorectal carcinoma who have progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing regimens. Bevacizumab, an anti-VEGF monoclonal antibody, was approved for metastatic colon cancer and has spurred further research into antiangiogenic therapies. While VGT-309 focuses on tumor visualization using near-infrared fluorescence, these approved drugs target specific molecular pathways to inhibit tumor growth and progression.

What other types of research exist?

Promising novel alternatives to VGT-309 for colorectal cancer patients include: 1) Combination therapy with trifluridine, tipiracil, and nintedanib, which has shown preclinical promise. 2) Molecular fluorescence-guided surgery using bevacizumab-IRDye800CW, which has been deemed safe and feasible for improved patient selection and optimization of cytoreductive surgery. 3) Radioimmunotherapy (RIT) for small volume disease, which may offer a therapeutic alternative to traditional chemotherapy.

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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 below

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I am scheduled for a colonoscopy in the operating room before surgery or for restaging after treatment.

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I am 18 years old or older.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 days for reporting.

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 • NCT05400226

100%

Procedural pain

63%

Pneumothorax

43%

Hypotension

23%

Nausea

18%

Urinary retention

15%

Hypoxia

15%

Sinus bradycardia

15%

Dyspnoea

13%

Vomiting

13%

Hypomagnesaemia

10%

Cough

10%

Aspartate aminotransferase increased

10%

Supraventricular extrasystoles

Hypokalaemia

Supraventricular tachycardia

Arthralgia

Tachycardia

Subcutaneous emphysema

Pulmonary oedema

Fatigue

Wheezing

Oropharyngeal pain

Gamma-glutamyl transferase increased

Atrial fibrillation

Amylase increased

Somnolence

Constipation

Dizziness

Hypocalcaemia

Hypertension

Hallucination

Ileus

Hypervolaemia

Respiratory failure

Traumatic haemothorax

100%

80%

60%

40%

20%

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

0 / 6Eligibility criteria met

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.