A Study of SGN-B7H4V in Advanced Solid Tumors
This study is looking into a new medicine, SGN-B7H4V, for adults with advanced solid tumours. This means cancers that have spread to other parts of the body or have come back after previous treatments. The study is in its very early stages (Phase 1), which means it's the first time this medicine is being given to people. Researchers want to find a safe dose of SGN-B7H4V and understand how it affects the body. It’s for people with specific types of cancer, such as certain breast cancers (triple-negative, HER2-negative, HR-positive), lung cancer, ovarian cancer, and others like fallopian tube, gallbladder, and endometrial cancers. The main goal is to see if it’s safe and to learn about any early signs of it working.
At a glance
What is this study about?
This study is exploring a new experimental medicine, known as SGN-B7H4V, for people who have advanced solid tumours. 'Advanced' means the cancer has either spread from where it started to other parts of the body, or it has returned after previous treatments. 'Solid tumours' refer to cancers that form a lump or mass, rather than blood cancers like leukaemia.
The study is in a very early stage called 'Phase 1'. This is often the first time a new medicine is given to people. At this stage, doctors are not yet trying to prove the medicine cures cancer. Instead, their main goals are to find a safe dose that patients can take, understand how the medicine behaves in the body, and carefully watch for any side effects. They also start to look for any early signs that the medicine might be helpful against the cancer.
Researchers are particularly interested in using SGN-B7H4V for several types of cancer that have reached an advanced stage. These include specific forms of breast cancer (like triple-negative, HER2-negative, and HR-positive breast cancer), a type of lung cancer (squamous cell carcinoma), certain ovarian cancers (high-grade serous epithelial), and other less common cancers such as fallopian tube, gallbladder, primary peritoneal, adenoid cystic carcinoma, endometrial, and cholangiocarcinoma. By testing this new medicine, doctors hope to find new ways to treat these difficult-to-manage cancers.
Key takeaways
- Tests a new medicine, SGN-B7H4V, for advanced solid cancers.
- It's an early-stage (Phase 1) study, focusing on safety and dosage.
- Targets specific cancers: breast (triple-negative, HER2-negative, HR-positive), lung, ovarian, and others.
- Open to adults aged 18 and over, both men and women.
- Requires regular hospital visits and health monitoring.
- You can withdraw from the study at any time.
Who may be eligible?
This study is looking for adults aged 18 or older. Both men and women are welcome to take part.
To join, you must have a specific type of advanced solid tumour that has either spread or returned after previous treatments. This includes certain types of breast cancer, lung cancer, ovarian cancer, and others like fallopian tube, gallbladder, and endometrial cancers. The medical team will check to ensure your cancer type matches the study requirements.
There will also be other medical checks to make sure taking part is safe for you. This might include reviewing your general health, other medical conditions you have, and any medicines you are currently taking. The study doctors will go through all the detailed requirements with you to see if you are a good fit for this research.
- Are you 18 years old or older?
- Do you have an advanced solid tumour (cancer that has spread or returned)?
- Is your cancer one of these types: fallopian tube, gallbladder, triple-negative breast, primary peritoneal, HER2-negative/HR-positive breast, specific non-small cell lung, high-grade serous epithelial ovarian, adenoid cystic carcinoma, endometrial, or cholangiocarcinoma?
- Are you able to travel to regular hospital visits for assessments and treatment?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you would receive the new medicine, SGN-B7H4V. Because this is a Phase 1 study, the main focus is on safety and finding the right dose. This means you would have regular visits to the hospital or clinic, which might be quite frequent, especially at the beginning. During these visits, doctors and nurses would perform various assessments. This includes physical examinations, blood tests, urine tests, and scans (like CT or MRI) to check your health and how your body is responding to the medicine.
They will also closely monitor for any side effects. You will be asked about any symptoms you experience. The total length of time you take the study medicine will depend on how you respond and how you are feeling, but it can continue as long as the medicine is helping and you are tolerating it well. There will also be follow-up appointments after you stop taking the study medicine, to make sure you are doing well.
Potential risks and benefits
Locations (4)
- —France
- —Spain
- —Italy
- —Germany
Common questions
What does 'advanced solid tumours' mean?
It means the cancer started as a lump or growth and has either spread to other parts of the body or has come back after treatment.
What is a 'Phase 1' study?
This is an early stage of testing a new medicine in people for the first time. The main goals are to find a safe dose and understand how it works.
Will I definitely get the new medicine?
Yes, if you join this study, everyone receives the new medicine called SGN-B7H4V.
What kinds of checks will I have if I join?
You'll have regular hospital visits, physical exams, blood and urine tests, and scans to monitor your health and how the medicine is affecting you.
Can I leave the study if I change my mind?
Yes, you are free to leave the study at any time, and this will not affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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