A Phase I/IIa study of intra-tumoral BT-001 (TG6030) administered alone, and in combination with pembrolizumab in patients with cutaneous or, subcutaneous lesions or, easily injectable lymph nodes of metastatic/advanced solid tumors.
This clinical trial is designed to investigate new treatment options for patients with advanced or metastatic solid tumours, including soft tissue sarcoma, Merkel cell carcinoma, melanoma, triple negative breast cancer, or non-small cell lung cancer. The study is divided into two parts. In the first part (Phase I), we are primarily focused on checking the safety of a new drug called BT-001, given directly into cancer growths, either alone or alongside pembrolizumab. We want to understand any side effects. In the second part (Phase IIa), we will look at how well these treatments work in slowing down or shrinking the cancer in different groups of patients over time. This research aims to find more effective and safer ways to treat these cancers.
At a glance
What is this study about?
This study is particularly for people who have advanced cancers which have spread to other parts of the body. These include types like soft tissue sarcoma, Merkel cell carcinoma, melanoma, a specific type of breast cancer (triple negative), and non-small cell lung cancer. We are focusing on cancers that have visible or easily reachable growths on or under the skin, or in lymph nodes, as this allows us to directly inject the new drug.
At the heart of this research is a new treatment called BT-001, also known as TG6030. We are testing this drug in a few ways: either on its own, or combined with another medicine called pembrolizumab. Pembrolizumab is already used to treat some cancers and works by helping your body's immune system fight the cancer. We want to see how safe this new drug (BT-001) is, what side effects it might have, and if it can help control the cancer's growth or even shrink it.
This is an early-stage study, meaning it's one of the first times this new treatment is being given to people. The study has two main phases – Phase I and Phase IIa. Phase I is mostly about checking safety, while Phase IIa moves on to look more closely at how well the treatment works in different groups of patients.
Key takeaways
- This study is testing new treatments for specific advanced cancers.
- It involves a new drug (BT-001) given directly into cancer growths.
- Some patients will also receive an established immunotherapy drug (pembrolizumab).
- The study aims to check safety and how well the treatments work.
- Participation includes regular clinic visits, tests, and monitoring.
- Your decision to join is completely voluntary and you can leave at any time.
Who may be eligible?
To be considered for this study, you must be at least 18 years old. Both men and women are welcome to take part. The study is specifically for patients who have been diagnosed with certain types of advanced cancer that have spread.
These specific cancer types include advanced soft tissue sarcoma, Merkel cell carcinoma, melanoma, triple-negative breast cancer, or non-small cell lung cancer. It's important that your cancer has visible or easily reachable growths on the skin, under the skin, or in lymph nodes that can be injected.
Several other important medical details will also be checked by the study doctor to make sure this trial is the right and safest option for you. These checks involve your general health, how well your organs are working, and any other medications you might be taking. This is to ensure your safety throughout the study.
- Are you at least 18 years old?
- Do you have advanced soft tissue sarcoma, Merkel cell carcinoma, melanoma, triple negative breast cancer, or non-small cell lung cancer?
- Does your cancer have growths that are on or under the skin, or in easily reachable lymph nodes?
- Are you generally well enough to take part in a clinical study?
- Are you able to attend regular clinic appointments for treatment and check-ups?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you will receive either the drug BT-001 by itself, or BT-001 along with pembrolizumab. BT-001 is given as an injection directly into your cancer growths. Pembrolizumab is given into a vein. You will have regular visits to the clinic for treatments, check-ups, and to monitor any side effects.
These visits will involve blood tests, scans (like CT or MRI scans) to see how your cancer is responding, and physical examinations. You might also have further tests depending on your specific situation. The exact number of visits and the total length of your participation will vary, but you will be closely monitored throughout.
There might also be a follow-up period after your main treatment has finished to continue checking your health and the long-term effects of the treatment. All these details will be fully explained before you decide to take part.
Potential risks and benefits
Locations (2)
- —Belgium
- —France
Common questions
What is BT-001?
BT-001 is a new experimental drug being investigated in this study. It's given by injecting it directly into cancer growths.
What is pembrolizumab?
Pembrolizumab is a type of immunotherapy that helps your body's own immune system fight cancer. It's sometimes given alongside BT-001 in this study.
What does 'intra-tumoral' mean?
It means the medicine is injected directly into the cancer tumour or growth itself, rather than into a vein or muscle.
What kind of cancers are included?
This study is for people with advanced soft tissue sarcoma, Merkel cell carcinoma, melanoma, triple negative breast cancer, or non-small cell lung cancer that have spread.
What is the main goal of this study?
The main goals are to find out if the treatments are safe and what side effects they might cause, and to see if they can help control or shrink the cancer.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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