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Study on the Safety and Effectiveness of ATTR-01 for Adults with Certain Types of Solid Tumors

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What is this trial about?

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

This clinical trial is focused on studying a new treatment for certain types of cancer known as epithelial solid tumors. These are cancers that start in the cells that line the surfaces of organs and tissues in the body. The treatment being tested is called ATTR-01, which is a special type of medicine designed to target and attack cancer cells. It is given to patients through an injection into a vein, known as an intravenous method.

The purpose of the study is to understand how safe and tolerable ATTR-01 is for patients with these types of cancers. The study will also look at how well the treatment works in shrinking or controlling the tumors. ATTR-01 is a genetically modified virus that specifically targets cancer cells that have a certain protein on their surface. Once inside the cancer cells, it helps the body’s immune system to fight the cancer by producing a cancer-fighting antibody called atezolizumab.

Participants in the study will receive either the ATTR-01 treatment or a placebo. The study will be conducted in different phases to determine the best dose of the treatment and to monitor its effects over time. Patients will be closely observed for any side effects and to see how their cancer responds to the treatment. The study aims to provide valuable information that could lead to new treatment options for people with these types of cancers in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be informed about the trial's purpose, procedures, and potential risks and benefits. You will be asked to provide your consent to participate.
You must meet specific criteria, such as being an adult with a certain type of cancer and having a life expectancy of more than three months.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate your health status. This includes checking your organ function and ensuring you have measurable disease according to specific criteria.
You will also be required to follow certain hygiene and protection measures, especially after receiving the treatment.
Step 3
Treatment administration
You will receive the study medication, ATTR-01, which is administered as an intravenous suspension. The dosage and frequency will be determined based on the specific sub-protocol you are enrolled in.
The treatment aims to evaluate the safety and effectiveness of ATTR-01 in treating your type of cancer.
Step 4
Monitoring and follow-up
Throughout the trial, you will undergo regular monitoring to assess your response to the treatment and any side effects. This includes scans and other clinical assessments.
The trial will track various outcomes, such as the response rate to the treatment and the duration of any response.
Step 5
End of participation
Your participation in the trial will conclude after the treatment period and follow-up assessments are completed.
You will be informed about the results of the trial and any further steps if applicable.

Who can join the trial?

12 criteria

Adults aged 18 years or older with certain types of solid tumors that have a high level of a specific protein called αvβ6 integrin receptor.
Must follow rules about stopping previous treatments and using birth control related to genetically modified organisms and cancer treatments.
For a specific part of the study (SP-A): Must have cancer confirmed by a test called a biopsy, and the cancer must be at stage IV.
For SP-A: Only those with tumors that can be safely accessed for a biopsy can join.
Can have had previous treatments with certain immune therapies, either alone or with other cancer treatments.
Must have tried and not responded to standard treatments, or cannot tolerate them, if eligible.
Must have a tumor that has not been treated with radiation and is safe for biopsies before and after treatment.
Must have measurable disease according to a specific set of guidelines called RECIST Version 1.1.
Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status scale, which measures daily living abilities.
Must have a life expectancy of more than three months.
Must agree to follow hygiene and protection measures, such as regular hand washing and avoiding close contact with certain groups of people for ten days after the last treatment. These groups include pregnant or breastfeeding women, children under one year old, nursing home residents, and people with weakened immune systems.
Must have adequate organ function.

Who cannot join the trial?

5 criteria

Patients with any medical condition other than select epithelial solid tumors cannot participate. Epithelial solid tumors are a type of cancer that starts in the cells that line the surfaces of organs.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may have additional risks or require special protections.
Patients who are not able to follow the study procedures or comply with the study requirements cannot participate.
Patients who have any other condition or factor that the study doctors believe would make it unsafe or inappropriate for them to participate cannot join the study.

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Verified sites

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Verified
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain

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Investigated drugs

ATTR-01 is a medication being studied for its potential to treat certain types of solid tumors that form in epithelial cells, which are the cells that line the surfaces of organs and structures in the body. The main goal of the study is to see if ATTR-01 is safe and well-tolerated by patients. Researchers are also trying to find the best dose of ATTR-01 to use in future studies. Additionally, they are looking at how well ATTR-01 can help reduce or control the growth of these tumors. This medication is given to patients through an intravenous (IV) infusion, which means it is delivered directly into the bloodstream through a vein.

ATTR-01

What is already known about the treatment

ATTR-01 – ATTR-01 is administered through an intravenous method, meaning it is delivered directly into the bloodstream via a vein. Currently, this medication is being studied in clinical trials to assess its safety and effectiveness in treating select epithelial solid tumors, which are a type of cancer. The main goal of using ATTR-01 is to evaluate its ability to reduce or control tumor growth in these specific cancers. At the molecular level, ATTR-01 works by targeting specific pathways that are involved in the growth and survival of cancer cells, although the exact mechanism is still under investigation. It is classified pharmacologically as an investigational cancer therapy, meaning it is still being tested and is not yet approved for general medical use.

Investigated diseases

Select Epithelial Solid Tumours – These are a group of cancers that originate in the epithelial cells, which line the surfaces and cavities of organs and structures throughout the body. The progression of these tumours typically involves the uncontrolled growth of abnormal cells that can invade nearby tissues. Over time, these tumours may spread to other parts of the body through the bloodstream or lymphatic system, a process known as metastasis. The growth rate and pattern of spread can vary depending on the specific type of epithelial tumour. As the tumour enlarges, it may cause symptoms related to the affected organ or tissue. The behaviour and characteristics of these tumours are influenced by their location, size, and cellular makeup.