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Study of AdVince (Modified Adenovirus) Treatment Through Hepatic Artery Injection in Patients with Advanced Neuroendocrine Neoplasms

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on treating neuroendocrine neoplasms (NENs), a group of tumors that can develop in various organs, most commonly in the digestive system and lungs. These tumors are often discovered at an advanced stage when they have already spread to other parts of the body. While surgery can cure some cases, more than half of patients have cancer that has spread, making complete removal impossible.

The treatment being tested is called AdVince (also known as ELC-100), which is a modified virus solution that is injected directly into the liver's artery. This medication is a specially engineered version of a human virus that has been modified to target tumor cells. The main purpose of this research is to determine if repeated injections of AdVince into the liver artery are safe for patients with NENs that have spread to other parts of the body.

The study involves giving participants injections of AdVince through the liver artery. During the treatment, doctors will monitor patients' health through blood tests and various imaging techniques including CT scans, MRI, and PET scans. They will also track how the body responds to the treatment by measuring substances in the blood that can indicate tumor activity. The treatment period lasts up to 7 days, and patients will be monitored for any side effects.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Your eligibility for the study will be evaluated based on medical history and test results.
Various tests will be performed, including blood tests to check liver function, blood cell counts, and clotting factors.
Imaging tests will confirm that less than 60% of your liver is affected by the disease.
Step 2
Treatment preparation
Your liver blood flow will be evaluated to ensure proper treatment delivery.
If you have a functioning neuroendocrine tumor, you will receive somatostatin analog medication.
Step 3
Treatment administration
You will receive AdVince, a solution for injection, directly into the liver artery.
The treatment consists of multiple infusions over several cycles.
Blood samples will be collected before injection, 24 hours after, and optionally 72 hours after injection.
Step 4
Monitoring during treatment
Your blood will be tested on days 1, 8, 22, and 50 to measure virus levels.
Your immune response will be checked through blood tests at the start, on day 8, and day 50.
Regular assessments will monitor any side effects of the treatment.
Step 5
Imaging and evaluation
You will undergo imaging tests (CT, PET, and/or MRI) before the first treatment and after the last treatment cycle.
Hormone levels will be regularly monitored throughout the treatment period.
Your disease progression will be evaluated 24 weeks after the fourth treatment cycle.
Step 6
Follow-up period
You will be monitored for 30 days after the last treatment dose.
Any side effects or changes in your condition will be documented during this period.

Who can join the trial?

17 criteria

Must provide written consent to participate in the study
Must be 18 years or older
Must use reliable contraception if sexually active and able to have children
Must have normal kidney function (creatinine blood test below 105 µg/ml)
Must have liver function tests (AST, ALT) less than 5 times the normal limit
Must have bilirubin (liver function test) less than 3 times the normal limit
Must have normal blood clotting tests (PT/INR below 2.0 and normal PTT)
Must have adequate blood cell counts: - White blood cells (neutrophils) above 1,500/µl - Red blood cells (hemoglobin) above 100 g/L - Platelets above 100,000/µl
If you have an active hormone-producing tumor, you must be taking somatostatin medications
Must have confirmed neuroendocrine tumor from gut, pancreas, or lung origin
Must show disease progression in the last 6 months on CT or MRI scans
Must have disease that cannot be removed by surgery
Must have tried all standard treatment options according to European guidelines
Must have proper blood flow to the liver
Must have cancer mainly affecting the liver, with less than 60% of liver involved
Must have good physical function (Karnofsky score 70% or higher, meaning able to care for self but unable to work)
Must have life expectancy of at least 6 months

Who cannot join the trial?

13 criteria

Prior treatment with any oncolytic virus therapy or gene therapy
Active autoimmune disease (a condition where your immune system attacks healthy cells in your body)
Presence of brain metastases (cancer that has spread to the brain)
Severe liver dysfunction
Active or chronic viral infections including hepatitis B, hepatitis C, or HIV
Pregnant or breastfeeding women
History of organ transplantation
Current use of systemic immunosuppressive medications (drugs that weaken the immune system)
Significant heart disease or uncontrolled high blood pressure
Other active cancers within the past 3 years (except for adequately treated non-melanoma skin cancer)
Major surgery within 4 weeks before starting the study
Known allergy or hypersensitivity to study medication components
Any condition that, in the opinion of the study doctor, would make participation unsafe

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Uppsala University Hospital
Uppsala, Sweden

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Investigated drugs

AdVince is a medical treatment that uses a modified virus (recombinant adenovirus) designed to target neuroendocrine tumors. It is given through infusion into the liver artery to reach cancer cells that have spread to the liver. This type of treatment is known as gene therapy, where the modified virus is engineered to specifically attack cancer cells while leaving healthy cells unharmed. The treatment is administered multiple times through the hepatic artery (the blood vessel that supplies blood to the liver).

Human Adenovirus C Serotype 5 With E1 Gene Controlled By Chromogranin A Promoter And Hexon Modified With Protein Transduction Domain Motif

What is already known about the treatment

AdVince – A recombinant adenovirus-based therapeutic agent administered through hepatic artery infusion, specifically designed for treating neuroendocrine neoplasms (NENs) with liver metastases. This investigational treatment belongs to the class of gene therapy products and works by using a modified adenovirus to target and destroy cancer cells in the liver. The medication is currently being studied in clinical trials to evaluate its safety and efficacy in patients with metastatic neuroendocrine tumors, with a particular focus on determining the maximum tolerated dose through repeated infusions into the hepatic artery.

Investigated diseases

Neuroendocrine neoplasms (NENs) - A diverse group of tumors that develop from specialized cells called neuroendocrine cells. These tumors can occur throughout the body but are most commonly found in the digestive system (gastroenteropancreatic system) and lungs. The condition varies in how it presents and develops, with different tumors showing different growth patterns and behaviors. Neuroendocrine neoplasms can produce various hormones and chemicals that affect body functions. The disease typically develops slowly over time, though some forms may grow more rapidly. These tumors can spread from their original location to other parts of the body, particularly to the liver.